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Morning Briefing

Summaries of health policy coverage from major news organizations

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Wednesday, May 10 2017

吃瓜不打烊 Original Stories 4

  • Nearly 1 In 3 Recent FDA Drug Approvals Followed By Major Safety Actions
  • Grassley, Chaffetz Send Fiery Response To HHS Memo They Say Chills Whistleblowing
  • Reactions To The GOP Health Bill: Voices From The States
  • Parents Of Sick Children Fear Trap If States Have Say On 'Preexisting Conditions'

Health Law 6

  • Amid Fierce Criticism, McConnell Defends All-Male Panel: 'Everybody Is At The Table'
  • In Senate, GOP Is Walking A Razor-Thin Margin And These Deal-Breakers Could Nudge Them Over Edge
  • Republican Health Replacement Bill's Provisions On Medicaid Are Key Concern For Senators
  • Republicans Face Angry, Rowdy Crowds At Town Halls
  • The Evidence Is Clear: People Do Die From Lack Of Access To Health Insurance
  • Journalist Arrested After Asking HHS Secretary About Preexisting Conditions In GOP Health Law

Administration News 3

  • Despite Senators' Concerns Over Ties To Pharma Industry, Gottlieb Confirmed To Lead FDA
  • As Push Grows For Ever-Faster Approvals, Report Finds One-Third Of FDA-Cleared Drugs Posed Safety Risks
  • Grassley And Chaffetz Skewer HHS Memo Limiting Employees' Comments To Congress

Marketplace 1

  • BlueCross BlueShield Of Tennessee Steps In To Fill Knoxville Market Gap

Capitol Watch 1

  • Window For Republicans To Roll Back Obama Regulations Closing

Public Health 2

  • House Panel To Investigate Role DEA And Drug Distributors Have Played In Opioid Flood
  • Harms Of Thyroid Cancer Screenings Outweigh Benefits, Task Force Says

Women鈥檚 Health 1

  • Week Of Anti-Abortion Movement Wins Buoys Supporters, Mobilizes Opponents

State Watch 2

  • Maryland Governor Selects Obamacare Critic To Lead State's Health Care Commission
  • State Highlights: D.C. Zika Testing Program Botched Results; Ga. Gov. Signs Optometry Bill But Also Issues Related Executive Order

Prescription Drug Watch 2

  • Money-Back Guarantees Protecting Patients From Buying A Lemon When It Comes To Pricey Drugs
  • Perspectives: When Drug Prices Are High Patients Take Fewer, Leading To More Expensive Care

Editorials And Opinions 3

  • Contemplating GOP Health Plan Politics: Can The Senate's Panel Of White Men Come To The Rescue?; Who Voted How And Said What?
  • Different Takes: Obamacare's Impact On Families' Financial Health; Can Washington Get Health Care Right?
  • Viewpoints: The Link Between Despair And The Opioid Crisis; Big Tobacco And E-Cigarettes

From 吃瓜不打烊 - Latest Stories:

吃瓜不打烊 Original Stories

Nearly 1 In 3 Recent FDA Drug Approvals Followed By Major Safety Actions

More than 70 drugs approved from 2001 through 2010 ran into safety concerns later that resulted in withdrawals from the market, 鈥渂lack box鈥 warnings or other actions. ( Sydney Lupkin , 5/9 )

Grassley, Chaffetz Send Fiery Response To HHS Memo They Say Chills Whistleblowing

The two Republican lawmakers sent a letter to HHS Secretary Tom Price warning him that whistleblowers in HHS could be intimidated into silence by a department memo instructing employees to get clearance before talking with members of Congress and their staffs. ( Rachel Bluth , 5/9 )

Reactions To The GOP Health Bill: Voices From The States

What will happen to people with preexisting conditions is one worry some Americans expressed; the high costs of insurance under Obamacare is another. ( 5/10 )

Parents Of Sick Children Fear Trap If States Have Say On 'Preexisting Conditions'

"I'm not going to risk my son's health on the political whims of Jefferson City," says one Missouri father, whose son requires about $20,000 to $30,000 in medical care expenses a year. The new GOP health bill to repeal the Affordable Care Act lets states decide whether or not insurers must cover people with preexisting conditions, such as birth defects. ( Bram Sable-Smith, Side Effects Public Media , 5/10 )

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Summaries Of The News:

Health Law

Amid Fierce Criticism, McConnell Defends All-Male Panel: 'Everybody Is At The Table'

Democrats are concerned that there are no women involved in the health law working group because they say the legislation is particularly harmful to women.

The Senate passed a significant milestone this year: 21 of its members are now women, the highest number in American history. But as the recent wrangling over the American health care system in Congress shows, there isn鈥檛 always power in numbers. After the House passed a health care bill that gave states the option to drop pregnancy and maternity care from required insurance coverage, Republican leaders in the Senate seemed poised to answer criticism from women. Instead they courted more, naming a 13-member, all-Republican working group on health care legislation, without a single woman on it 鈥 forcing Senator Mitch McConnell of Kentucky, the majority leader who approved the panel, on the defensive on Tuesday. (Steinhauer, 5/9)

After a meeting of the Senate healthcare group, lawmakers were bombarded with questions as to why no women were named to the 13-man panel. Senate Majority Leader Mitch McConnell tried to explain. "The working group that counts is all 52 of us," McConnell told reporters, referring to all 52 Republican senators in the 100-member chamber. "Nobody is being excluded based upon gender ... Everybody's at the table. Everybody." Democrats pounced. Republican men are negotiating "a secret healthcare plan, which I really hope is not happening in the men's locker room," said Senator Patty Murray, a member of the Democratic leadership from Washington state. (5/9)

McConnell also downplayed the working group鈥檚 importance, arguing his entire conference will be involved in the debate. 鈥淣obody is being excluded based upon gender,鈥 he said. (Bolton and Sullivan, 5/9)

The Senate working group met on Tuesday and Sen. Shelley Moore Capito (R., W. Va.) attended to participate in a discussion on Medicaid, but she is not joining the group on a permanent basis, a spokeswoman said. Republican Sen. Lisa Murkowski of Alaska said 鈥淸I] sure hope so鈥 when asked if a woman would be added to the health-care working group. 鈥淚 just want to make sure we have some women on,鈥 she added. Sen. Susan Collins (R., Maine) spoke for about 15 minutes in the Senate GOP lunch on Tuesday on the health-care proposals and said she planned to continue to participate in the debate.鈥淚鈥檓 going to keep speaking up regardless,鈥 Ms. Collins said. 鈥淲e know how to make our voices heard.鈥 (Peterson, 5/9)

Republicans can afford to lose only two of their own members on any Obamacare repeal bill, which they plan to pass using powerful budget reconciliation procedures that can circumvent Democratic filibusters. 鈥淚t鈥檚 just foolish to think that we鈥檙e excluding somebody,鈥 Cornyn said. (Schor and Everett, 5/9)

On Tuesday, all 48 members of the Senate Democratic Caucus released a letter to McConnell asking for Republicans to include Democrats as they work on health care, and promising that they would oppose wholesale changes to the health care law. (Yokley, 5/9)

Senate Democrats pounced on the issue to paint GOP leaders as insensitive to women鈥檚 healthcare needs. "If you look at the House bill, it is so discriminatory against women," said Senate Democratic Leader Charles Schumer (N.Y.). (Bolton, 5/9)

In Senate, GOP Is Walking A Razor-Thin Margin And These Deal-Breakers Could Nudge Them Over Edge

Politico looks at four hot-button topics that could cost Republican votes needed to pass health care legislation. Other media outlets offer explanations on taxes, the Byrd Rule and what will happen if the senators can't pass a repeal-and-replace law.

The Senate鈥檚 fresh attempt to dismantle Obamacare is already running into its first roadblock 鈥 the growing list of demands from GOP lawmakers eager to leave their own mark on the legislation. Just days into the chamber鈥檚 health care debate, centrists and self-styled mavericks are testing the party鈥檚 razor-thin margin for victory and setting the stage for a series of high-profile negotiations. Those stare downs are likely to shape big parts of the legislation, since GOP leaders can only absorb two defections if Democrats and the chamber鈥檚 two independents stand unified in opposition. (Cancryn, 5/9)

Sen. Ted Cruz, a defiant loner whose feuds with Republican Party leaders have made him a conservative favorite, suddenly felt an itch to collaborate. It was late March, just after the dramatic collapse of House Republicans鈥 initial attempt to pass a sweeping overhaul of the nation鈥檚 health-care system. Cruz (R-Tex.) sent notice to party colleagues that he wanted to convene a working group to keep alive the GOP鈥檚 pledge to undo the law known as Obamacare. (Costa and Sullivan, 5/9)

After four years of taunting and torturing fellow Republicans, Ted Cruz is shedding his just-say-no persona in the Senate for a new identity: Team player. And this is no idle tryout. Majority Leader Mitch McConnell 鈥 a man Cruz once derided as a liar and an ally of Democrats 鈥 is counting on the Texan to help navigate an Obamacare repeal bill through the Senate with virtually no margin for error. As a trusted voice of the conservative wing of the GOP and conduit to the House Freedom Caucus, Cruz is fast emerging as a pivotal player in the Republican bid to do away with the landmark Democratic health care law. (Everett, 5/9)

As they take up the campaign to replace the Affordable Care Act, Senate Republicans face a critical choice between cutting taxes or preserving health coverage for millions of Americans, two competing demands that may yet derail the GOP push to roll back the 2010 healthcare law. House Republicans, who passed their own Obamacare repeal measure last week, skirted the dilemma by cutting both taxes and coverage. (Levey, 5/9)

Republican senators said it鈥檚 unclear whether their chamber will repeal all of the taxes imposed under Obamacare as they set aside the health-care bill passed by the House and prepare to write their own from scratch.鈥淭hat鈥檚 hard to say right now. We just have to see,鈥 said Senate Finance Chairman Orrin Hatch, the Utah Republican whose panel oversees health-care and tax policy. 鈥淚t鈥檚 going to be negotiated.鈥 (Kapur, 5/9)

The success of Republican efforts to repeal and replace Democrat Barack Obama's Affordable Care Act could depend on an obscure Senate rule that few people have heard of and even fewer understand. It's called the Byrd rule, named for the late West Virginia Sen. Robert Byrd and designed decades ago to preserve Senate filibuster rights. What it means for health care is that many Republican ideas may be ruled ineligible. (5/10)

Senate Republicans want to do their own Obamacare repeal plan 鈥 but they have about 52 different ideas about how to do it. Several working groups and coalitions have sprung up as GOP lawmakers start to figure out exactly how they鈥檙e going to repeal the Affordable Care Act. (Haberkorn, 5/9)

Republicans in Washington are taking a massive risk when it comes to health insurance policy, and it鈥檚 separate and apart from passing a bill through the House of Representatives that restructures the US healthcare system without a score from the聽Congressional Budget Office. From President Trump on down, Republicans are pointing to the fact that as insurance companies are abandoning the health insurance exchanges created by the Affordable Care Act, they're slowly creating a situation in which some Americans will have no exchange-based options at all in 2018. (Garver, 5/9)

It鈥檚 only the first full work week since the Senate received the House-passed measure to reorder the nation鈥檚 health insurance system, and leaders in both parties are wasting no time hurling criticism at each other over how to approach the legislation. Using the time reserved for leadership press conferences after Tuesday鈥檚 policy lunches, Republicans criticized Democrats for refusing to come to the table and negotiate a fix to a health care system they described as in chaos. Democrats accused the GOP of crafting a bill in secret, by an all-male working group, that would drastically reduce benefits for vulnerable people. (Williams, 5/9)

Sen. John Cornyn (R-Texas) pledged Tuesday that the Senate will pass a bill repealing and replacing ObamaCare this year. Senators have been cautious not to commit themselves to an exact timeframe聽in the wake of last week鈥檚 House vote, but the upper chamber鈥檚 No. 2 Republican has said healthcare reform will be completed in 2017. When pressed by reporters on whether a measure would be passed before the end of the fiscal year on Sept. 30, he wouldn鈥檛 commit. (Roubein, 5/9)

As the American Health Care Act moves toward the Senate, many people around the country are reacting to it. Among them, people with preexisting conditions who worry about losing their coverage.One of the biggest concerns about the House bill is its treatment of preexisting conditions. Several lawmakers were worried it would leave sicker people in the lurch, so an additional $8 billion was negotiated to help that population. (5/10)

The Senate's ObamaCare repeal bill is unlikely to go through the committee process, Sen. Orrin Hatch (R-Utah) said Tuesday.聽"I don't think it's going to go through the committees, at least from what I know about it," the Senate Finance Committee chairman said. The Senate is devising its own healthcare plan rather than taking up the House's, which passed last week. (Hellmann, 5/9)

The Republican bill that passed the House is almost certain to undergo a makeover in the Senate. Still, it marks an opening gambit in a new conservative political landscape, a gambit with a huge real-world impact on families, their taxes and budgets. Opinions on the plan in Georgia, so far, are mixed, and often quite strong. (Hallerman, 5/9)

Republican Health Replacement Bill's Provisions On Medicaid Are Key Concern For Senators

One of the thorniest issues for Republicans is how to handle the Affordable Care Act's expansion of Medicaid.

Republican senators hailing from states that took ObamaCare's Medicaid expansion are taking different tacks on defending the program as much of their party looks to end it.聽Sen. Rob Portman (R-Ohio) told reporters Tuesday that he supports rolling back the Medicaid expansion by ending the extra federal money for it, as long as there is a "soft landing." But Sen. Shelley Moore Capito (R-W.Va.) told The Hill that she wants the expansion of coverage to remain, though she said it did not have to be in the same form.聽(Sullivan, 5/9)

Senators from states that expanded Medicaid met Tuesday to discuss issues such as how proposed tax credits could help consumers who enrolled in the federal-state program through the health care law's expansion, said Sen. Rob Portman, R-Ohio. The meeting was separate from another discussion on Medicaid held later among the senators tapped for a health care working group by Majority Leader聽Mitch McConnell,聽R-Ky. Portman, who said he has been talking with about 20 senators, met Tuesday with at least half a dozen Republicans from states that broadened Medicaid eligibility to the working poor under the 2010 health care law. 聽(Young and Mershon, 5/9)

The Senate has broken into a series of 鈥渨orking groups鈥 to begin writing its own version of legislation to replace the Affordable Care Act. There鈥檚 the leadership-driven group, a group of moderates and there was talk about a more conservative group before it was mostly absorbed into the leadership group. But the most powerful bloc in the Senate, based on the size and clout of its members, are the Republicans who come from states that took advantage of the 2010 health law鈥檚 federal expansion of Medicaid to provide insurance to millions of lower-income Americans. (Kane, 5/9)

Medicaid is becoming the Senate鈥檚 first focus as lawmakers try their hand at a bill to repeal and replace major parts of the Affordable Care Act. Though the topic received less attention in the House, how the replacement to the ACA treats expansion of the federal program for low-income Americans is set to be a major component of debate in the Senate. The opioid crisis is at the center of the issue for some Republican senators who represent states that expanded Medicaid. (McIntire, 5/9)

The House bill to repeal and replace parts of the Affordable Care Act makes big changes to how Medicaid operates and is funded, and those changes have healthcare providers worried. Officials at area hospitals fear the cuts will come on the backs of the most vulnerable in the state. (Christ, 5/9)

Proposed changes to expanded Medicaid making their way through Congress would effectively eliminate a program that has about 20,000 enrollees in North Dakota, the state鈥檚 lone congressional Democrat warned this week. ... the American Health Care Act would spell the end for Medicaid expansion, said Sen. Heidi Heitkamp, D-N.D., who derided the bill as a tax break for the richest Americans that would leave more people uninsured. 鈥淭he American Health Care Act is a horrible piece of legislation,鈥 Heitkamp said in an interview Monday. She has pushed for fixing parts of the current law instead of repealing it. (Hageman, 5/9)

The U.S. House health care overhaul legislation approved last week could trigger the end of the state鈥檚 Healthy Michigan Medicaid expansion program or require legislators to make major changes, the state鈥檚 health director said Tuesday. It would cost the state roughly $800 million a year to continue the low-income insurance plan on its own if federal funding is reduced to the standard matching rate for other Medicaid enrollees, said Michigan Health and Human Services Director Nick Lyon. (Oosting, 5/9)

Republicans Face Angry, Rowdy Crowds At Town Halls

Voters have been turning out in force to voice their objections to their lawmakers vote on the American Health Care Act.

United States representatives often hold town halls with constituents in their home districts during a congressional recess. But this week, with the House on a break, few of the 217 Republicans who approved legislation to repeal and replace critical parts of the Affordable Care Act, or Obamacare, chose to defend their votes at public meetings. Those who did were, in several cases, greeted by shouts and criticism. (Fortin and Victor, 5/9)

Town hall meetings got loud for some Republican members of Congress this week, as they defended the passage of the American Health Care Act by the House of Representatives. Constituents have been asking a lot of questions, and we've been fact-checking the answers given by some leading GOP lawmakers. (Kodjak, 5/9)

Critics of Republican U.S. Rep. Dave Brat and the House health care bill he voted for packed a raucous town hall meeting in his Virginia district Tuesday night, booing and shouting down the congressman from start to finish. (5/9)

Rep. Dave Brat faced a rancorous crowd at a town here Tuesday night that took issue with his positions on health care, Russia investigations and, frankly, most other topics. Brat, meanwhile, took issue with many of the attendees鈥 frequent shouting over him, saying it was counterproductive to civil discourse. ... Contention defined the hour-and-a-half town hall, which was co-hosted by Brat and Virginia state Sen. Amanda Chase. Health care was the hot topic, but questions touched on a wide array of issues from the federal budget process to President Donald Trump鈥檚 tax returns to environmental and internet policies. (McPherson, 5/9)

鈥淓verybody asks for town halls so we can have civil discourse,鈥 a frustrated Brat told more than 700 people at a suburban Richmond church. 鈥淭hat鈥檚 what I鈥檓 trying to do. If we go this route, it鈥檚 going to be very hard to have rational civil discourse. I鈥檓 trying.鈥 Trouble began even before Pastor Stan Grant of Clover Hill Assembly of God finished his invocation. As he prayed to God that the discussion would go forth 鈥渋n a way that will honor you,鈥 a handful of Brat鈥檚 critics stood holding small signs aloft. 鈥淣ope,鈥 鈥淪hame鈥 and 鈥淪top using the Bible as a weapon,鈥 they read. (Vozzella, 5/10)

House Republicans should not have celebrated the chamber鈥檚 passage of its health care bill last week, one of their own said Tuesday. Rep. Peter King (R-N.Y.) said the narrow vote to pass legislation to repeal and replace Obamacare was too serious an issue to commemorate the way President Donald Trump, administration aides and House Republicans did Thursday 鈥 with a public celebration at the White House. (McCaskill, 5/9)

Rep. Rodney Frelinghuysen may have escaped a rowdy crowd by holding a town hall via telephone, but that didn鈥檛 stop constituents from repeatedly hammering the New Jersey Republican Tuesday evening over his recent support of the House Obamacare repeal bill. Frelinghuysen, chairman of the House Appropriations Committee, was repeatedly forced during the one-hour event to justify why he voted in favor of the American Health Care Act last week after having opposed an earlier version of the bill. (Jennings, 5/9)

About 30 demonstrators, some holding signs that read 鈥淧utin鈥檚 favorite congressman,鈥 鈥淒ump Dana 2018鈥 and 鈥淛ust say no to Trumpcare,鈥 gathered outside Rep. Dana Rohrabacher鈥檚 office in downtown Huntington Beach on Tuesday afternoon to protest the Republican congressman鈥檚 support for President Trump鈥檚 policies. The gathering was organized by Indivisible OC 48, a left-leaning group of constituents in Rohrabacher鈥檚 48th Congressional District who have planned protests outside his office at 101 Main St. since Trump鈥檚 inauguration. They started at the office and marched down the street to the pier. (Fry, 5/9)

One House Democrat was in enemy territory Monday night, and he was on a mission. 鈥淚鈥檓 Rep. Sean Patrick Maloney,鈥 the New York lawmaker told a crowd gathered at an industrial event space in Kingston in a neighboring Empire State district. 鈥淲here the heck is your congressman?鈥 Maloney was participating in his 鈥淎dopt a District鈥 event, an idea he had after he found out that the 19th District鈥檚 Republican congressman, Rep. John J. Faso, was not holding town hall meetings during the weeklong House recess. So far, at least three other House Democrats are planning to do the same, though Maloney said the effort is not centrally organized. (Bowman, 5/10)

Wisconsin Rep. Mark Pocan has accepted an invitation to attend a town hall in Kenosha on Friday despite it being in a neighboring congressional district represented by Speaker Paul D. Ryan. Pocan became the latest Democratic member of Congress to show up in a Republican district in recent days 鈥 mostly to hear from constituents about the health care bill the House passed last week. Many Republicans, meanwhile, have largely stayed out of public view during the current recess. (Rema Rahman, 5/9)

As part of a tweet storm condemning the House Republican bill to overhaul the Affordable Care Act, Sen. Kamala D. Harris (D-Calif.) used a talking point that a number of Democrats have used when attacking the changes that proposed legislation would make concerning the handling of preexisting medical conditions in the individual market.聽We have examined those changes in depth in a report and exposed the false talking point that rape or sexual assault would be considered a preexisting condition. So how does this figure of 129 million fare? (Kessler, 5/10)

The Evidence Is Clear: People Do Die From Lack Of Access To Health Insurance

Critics were quick to contradict Rep. Raul Labrador (R-Idaho) when he said, 鈥淣obody dies because they don鈥檛 have access to health care.鈥

Rep. Ra煤l Labrador, R-Idaho, found himself in a pickle (and in a cameo in a Jimmy Kimmel monologue) when he suggested they don鈥檛. He later elaborated that he was making the point that no one would 鈥渄ie in the streets鈥 under the Republican health care plan, because hospitals are required by law to treat any patient in need of emergency care. But health care advocates say his explanation falls short of reality, pointing to a host of studies that show access to health care does prevent premature death, in the case of Americans with conditions such as cancer, diabetes, coronary heart disease, respiratory failure and asthma. (Clark, 5/9)

California Sen. Kamala Harris had some heated words this week for an Idaho congressman's assertion at a town hall that 鈥渘obody dies because they don鈥檛 have access to healthcare." "Like this guy, this congressman, you might as well say, 鈥楶eople don't starve because they don't have food.' What the ... is that?聽What are you saying? How聽can you say that?" Harris said during an interview with Pod Save America, a聽podcast run by former Obama administration staffers. It was recorded live in front of聽an audience of more than 2,000 people in San Francisco, according to her staff. (Wire, 5/9)

Journalist Arrested After Asking HHS Secretary About Preexisting Conditions In GOP Health Law

Dan Heyman, a veteran journalist with Public News Service, was jailed on the charge of willful disruption of state government processes and was released later on $5,000 bail.

As Health and Human Services Secretary Tom Price walked through a hallway Tuesday in the West Virginia State Capitol, veteran reporter Dan Heyman followed alongside him, holding up his phone to Price while attempting to ask him a question. Heyman, a journalist with Public News Service, repeatedly asked the secretary whether domestic violence would be considered a preexisting condition under聽the聽Republican bill to overhaul the nation鈥檚 health care system, he said. 鈥淗e didn鈥檛 say anything,鈥 Heyman said聽later in a news conference. 鈥淪o I persisted.鈥 (Schmidt, 5/10)

Dan Heyman, a reporter for Public News Service, said he was arrested at the West Virginia State Capitol after trying to ask Health and Human Services Secretary Tom Price a question about the House-passed healthcare bill to repeal and replace ObamaCare...According to Heyman鈥檚 account, he waited for Price to come into the building and then reached past those accompanying Price with his phone and repeatedly asked his healthcare questions, adding that a number of other reporters wanted to bring up the issue of preexisting conditions. (Beavers, 5/9)

Administration News

Despite Senators' Concerns Over Ties To Pharma Industry, Gottlieb Confirmed To Lead FDA

Dr. Scott Gottlieb was seen as a moderate choice of President Donald Trump, compared with other candidates he was reportedly considering.

The Senate voted 57 to 42 on Tuesday to confirm Dr. Scott Gottlieb as commissioner of the Food and Drug Administration, where he will be responsible for regulating drug companies to which he has had close ties in recent years. Dr. Gottlieb, 44, has promised to divest himself from several health care companies and recuse himself for one year from decisions involving those businesses, but that was not enough for many Democratic senators, including Patty Murray of Washington. (Thomas, 5/9)

Gottlieb, a physician and venture capitalist with long ties to the pharmaceutical industry, served as a deputy聽FDA commissioner and a high-ranking official at the Centers for Medicare and Medicaid Services during the George W. Bush administration. He assumes the agency's helm as it faces mounting pressure from President Trump and other Republicans to further accelerate its drug-approval process and to take a more aggressive role in combating the nation's opioid epidemic. (McGinley, 5/9)

Gottlieb is a far more traditional candidate than others Trump initially considered for the job, including associates of activist financier Peter Thiel, who pledged to blow up the entire approval process by no longer mandating drugs demonstrate effectiveness before they can be sold. However, Gottlieb is still expected to push the boundaries of FDA reviews and using new authority under the 21st Century Cures Act to speed up evaluations. (Karlin-Smith and Griffiths, 5/9)

鈥淒r. Gottlieb has the necessary experience to serve in this key role. Not only has he worked in hospitals, interacted directly with those affected by disease and treatment, but he also has developed and analyzed medical policies in both the public and private sectors,鈥 said Majority Leader Mitch McConnell, R-Ky. (Siddons, 5/9)

Gottlieb is expected to speed up the approval of new drugs and devices, a process he has called too slow and burdensome. He has also advocated for greater physician autonomy to decide to administer experimental drugs for patients. (DIckson, 5/9)

At the FDA, one of Gottlieb鈥檚 top priorities will be confronting the opioid crisis. Several Democrats have raised concerns about the FDA鈥檚 role in responding to rising rates of opioid addiction across the nation. At his Senate confirmation hearing in April, Gottlieb said tackling the opioid epidemic was the 鈥渂iggest crisis facing the agency.鈥 (Reid, 5/9)

As Push Grows For Ever-Faster Approvals, Report Finds One-Third Of FDA-Cleared Drugs Posed Safety Risks

Problems with 71 of the 222 drugs approved in the first decade of this millennium were discovered after the drugs were approved, according to a new study. Those "safety events" warranted a 鈥渂lack box鈥 warning on side effects or a safety announcement about the dangers.

Almost a third of drugs cleared by the Food and Drug Administration pose safety risks that are identified only after their approval, according to a study聽published Tuesday. The researchers said the study, which appeared in JAMA, shows the need for ongoing monitoring of new treatments years after they hit the market. 鈥淲e seem to have decided as a society that we want drugs reviewed faster,鈥 said lead author Joseph Ross, an associate professor of medicine and public health at Yale University. That makes it critically important 鈥渢hat we have a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively,鈥 he said. (McGinley, 5/9)

The rate of such new safety issues after approval by the Food and Drug Administration was about twice as high among drugs that won accelerated approvals from the agency, compared to medicines approved in standard ways. (Burton, 5/9)

鈥淲hile the administration pushes for less regulation and faster approvals, those decisions have consequences,鈥 Ross said. The Yale researchers鈥 previous studies concluded that the FDA approves drugs faster than its counterpart agency in Europe, and that the majority of pivotal trials in drug approvals involved fewer than 1,000 patients and lasted six months or less. (Lupkin, 5/9)

Grassley And Chaffetz Skewer HHS Memo Limiting Employees' Comments To Congress

In a letter, the chairmen of key committees in the Senate and House say the guidance to workers at the Department of Health and Human Services 鈥渋s potentially illegal and unconstitutional, and will likely chill protected disclosures of waste, fraud, and abuse.鈥

An internal memo instructing Health and Human Services employees to consult with senior department personnel before talking to Congress has outraged two congressional Republicans, and they're demanding answers from Secretary Tom Price. In a letter released Tuesday, Sen. Chuck Grassley of Iowa and Rep. Jason Chaffetz of Utah said federal employees have a constitutional right to communicate directly with Congress. (Freking, 5/9)

Senate Judiciary Committee Chairman Charles E. Grassley (R-Iowa) and House Oversight and Government Reform Committee Chairman Jason Chaffetz (R-Utah) said the policy that Price鈥檚 chief of staff outlined in a memo last week 鈥渋s potentially illegal and unconstitutional, and will likely chill protected disclosures of waste, fraud, and abuse.鈥 (Eilperin, 5/9)

The chairmen acknowledge that the memo doesn鈥檛 鈥渦ltimately prohibit鈥 direct communication, but said 鈥渋t forces employees to expose their communications with Congress to agency management, necessarily subjecting them to a significantly increased risk of reprisal.鈥 Chaffetz and Grassley requested that HHS send written guidance to agency employees clarifying that they have a right to communicate 鈥渄irectly and independently with Congress.鈥 (Siddons, 5/9)

The May 3 memo from HHS Secretary Tom Price鈥檚 chief of staff, Lance Leggitt, instructed employees not to have 鈥渁ny communications鈥 with members of Congress or their staffs without first consulting the department鈥檚 assistant secretary for legislation. Leggitt鈥檚 memo said he was only restating a long-standing policy on congressional relations and gave eight examples of contacts needing approval, including requests for calls, briefings, hearings and oversight. (Bluth, 5/9)

Marketplace

BlueCross BlueShield Of Tennessee Steps In To Fill Knoxville Market Gap

In related news, early signals indicate that Affordable Care Act premiums will jump in the coming year and the Trump administration is stepping back from penalizing exchange plans that did not do risk-adjustment program audits.

Blue Cross Blue Shield of Tennessee said Tuesday it聽would re-enter the marketplace in a region of the state with no other option for individual health insurance, but that policies might cost more because of political uncertainty. Calling the move 鈥渁n extension of our mission,鈥 while noting the company appeared to be turning a corner in Tennessee after three tough years financially, BCBS President and CEO J.D. Hickey said the聽decision was an effort to lower risk as Congress and President Trump continue their efforts to repeal Obamacare. (Blau, 5/9)

BlueCross BlueShield of Tennessee will offer Affordable Care Act marketplace plans in the Knoxville region of Tennessee next year, filling a potential gap left when Humana Inc. announced it would pull out of all of the exchanges where it does business. The 16-county region had been at risk of having no insurer offering exchange plans in 2018, and the situation had gained attention as part of the political fight over the future of the ACA. (Wilde Mathews and Radnofsky, 5/9)

BlueCross BlueShield of Tennessee is negotiating with state officials about a聽return to the individual insurance market in 2018 in Knoxville聽鈥 an area that lacks an insurer for the next year.聽The decision is contingent upon the state agreeing to some conditions. The insurer still has reservations about the risk on the individual market but sees expanding into Knoxville as "an extension of our mission,"聽 J.D. Hickey, president and CEO of BCBST, wrote in a letter to the insurance commissioner dated May聽9. (Fletcher, 5/9)

Early clues suggest that health insurance prices in Affordable Care Act marketplaces could jump again for the coming year, defying predictions that premium rates would begin to level off. Amid the uncertainties hovering over those marketplaces as the Trump administration and a Republican Congress try to dismantle major parts of the law, many states have postponed for another few months their spring deadlines for insurers to report how much they want to charge for ACA health plans in 2018. (Goldstein, 5/9)

Uncertainty among insurers about how the Trump administration will handle the Affordable Care Act could translate into double-digit premium increases for 2018. Insurers are beginning to file rate requests with state insurance regulators, and some states could see premium increases of 50 percent or more. (Hellmann, 5/10)

Health insurance plans on the Affordable Care Act鈥檚 individual and small group markets in Virginia could cost an average of 20 percent more in 2018, according to initial rate filings with the state鈥檚 Bureau of Insurance. While the rates must be further reviewed by the bureau before they become final, the filings show that almost all insurers offering plans on the exchange expect premiums to increase. (O'Connor, 5/9)

The Trump administration won't penalize insurers for failing to verify the number of severely ill patients they've enrolled through the insurance exchanges. The Affordable Care Act established a risk-adjustment program that's aimed at preventing insurers from cherry-picking the healthiest members. Instead, the goal is to spread the insurance risk. Companies that cover people with complex health conditions receive money from companies that have generally healthier members. (Dickson, 5/9)

Capitol Watch

Window For Republicans To Roll Back Obama Regulations Closing

The Congressional Review Act gives Congress about 60 days to vote by a simple majority to overturn agency rules passed late in former President Barack Obama鈥檚 administration.

The window for Republicans to use an obscure law to rescind regulations enacted in the last six months of former President Barack Obama鈥檚 administration is closing, although at least one lawmaker is hoping a loophole may allow for an extension. ... The Congressional Review Act gives Congress about 60 days to vote by a simple majority to overturn agency rules passed late in Mr. Obama鈥檚 administration. That is a lower-than-usual threshold to pass legislation in the Senate, where 60 votes are often needed. (Andrews, 5/9)

Republicans intent on rolling back Obama-era regulations have made liberal use of a once-obscure tool: the Congressional Review Act. The act has been used to undo 13 regulations since President Donald Trump took office, and another one is on the president鈥檚 desk but hasn鈥檛 been signed. Removing the regulations聽has affected聽a range of issues聽from聽the environment to the workplace to health and education. (Beilfuss, 5/9)

Public Health

House Panel To Investigate Role DEA And Drug Distributors Have Played In Opioid Flood

The House Energy and Commerce Committee wants answers from the Drug Enforcement Administration about its efforts to combat the epidemic and from the nation鈥檚 three largest drug distribution companies about shipping practices. Other news stories focus on steps the Trump administration is taking to tackle the drug crisis.

A congressional committee Monday opened an investigation into the Drug Enforcement Administration鈥檚 slowdown of enforcement efforts in the face of a national opioid epidemic and demanded to know why drug distributors had shipped hundreds of millions of painkillers to communities in West Virginia. The House Energy and Commerce Committee sent letters to the DEA and the nation鈥檚 three largest drug distribution companies, giving them until June 8 to answer questions about their responsibilities to combat the rising epidemic, which has claimed nearly 180,000 lives during the past decade. (Higham and Bernstein, 5/9)

Cardinal Health and the nation鈥檚 two other dominant drug distributors are being investigated by a U.S. House subcommittee based on reports the companies did not give proper oversight to a spike in powerful painkiller orders in West Virginia between 2007 and 2012. The House Energy and Commerce Committee has given Cardinal, AmeriSourceBergen and McKesson a June 8 deadline to submit responses to its questions. (Rose, 5/9)

When Tom Price, U.S. secretary of health and human services, and presidential adviser Kellyanne Conway came to Lansing Tuesday, there was no talk about the vote in the House of Representatives last week to repeal and replace Obamacare and what impact that might have on Michigan. Instead the two members of President Donald Trump鈥檚 administration had a more personal issue to discuss with Gov. Rick Snyder: opioid abuse. (Gray, 5/9)

A Trump administration proposal to cut the $388 million budget of the Office of National Drug Control Policy by 95 percent has聽given new urgency to that question, with some administration officials arguing the ONDCP聽simply duplicates work already done by other agencies. They have also said the proposal is only preliminary. But Regina LaBelle, who worked in the office from October 2009 to January 2017 for the Obama administration, says slashing the office鈥檚 budget would be 鈥減enny-wise and pound-foolish,鈥 arguing that it makes work at agencies across the government more efficient. (Joseph, 5/10)

And from New York City聽鈥

John Harte has been shooting up heroin for more than four decades, but he cut back this year because he is afraid of fentanyl, an often deadly synthetic opioid being used to spike heroin. 鈥淚t鈥檚 really, really dangerous,鈥 said the 67-year-old Staten Island resident. 鈥淚t鈥檚 like you鈥檙e chasing a dream. And then when you wake up from the dream, your reality is a f鈥攊ng nightmare. Or you鈥檙e dead.鈥 (Kanno-Youngs, 5/9)

Harms Of Thyroid Cancer Screenings Outweigh Benefits, Task Force Says

Despite an industry-backed push for more people to be screened for thyroid cancer, the U.S. Preventive Services Task Force has added the option to its don't-do-it category. In other public health news: pain relievers and heart risks, statins, syphilis, mental health care for children, and smoking.

If you hear rock star Rod Stewart's husky voice in a radio spot imploring you to get your thyroid checked for cancer, don't be seduced. An industry-backed foundation has been putting out that message, with Stewart as a celebrity spokesman, but it's not based on sound science. No major medical organization recommends mass screening for thyroid cancer. (Harris, 5/9)

The pain relievers known as nonsteroidal anti-inflammatory drugs, or Nsaids, are known to carry heart risks. A new analysis found that those risks can arise within a week of starting the drugs. Researchers did a systematic review of studies involving more than 446,000 people ages 40 to 79, of whom more than 61,000 had heart attacks. (Bakalar, 5/9)

Statins, the widely used cholesterol-lowering drugs, have well-known side effects, but some of the most common may be caused more by psychological factors than by the drugs themselves. Researchers looked at more than 10,000 patients who had been randomly assigned to take either atorvastatin (Lipitor) or a placebo. They tracked their reports of more than two dozen different side effects over an average of more than three years. (Bakalar, 5/9)

Decades later, it's still hard to grasp what the federal government did to hundreds of black men in rural Alabama 鈥 even if you're among their descendants, lighting candles in their memory. For 40 years starting in 1932, medical workers in the segregated South withheld treatment for unsuspecting men infected with a sexually transmitted disease simply so doctors could track the ravages of the horrid illness and dissect their bodies afterward. (Reeves, 5/10)

Harvard researchers posing as the parent of a depressed 12-year-old called hundreds of child psychiatrists and pediatricians looking for appointments, and discovered what many actual parents know through bitter experience: Most of the time the calls were fruitless.聽The group phoned 913 doctors listed as network providers by Blue Cross Blue Shield organizations in Boston, Chapel Hill, N.C., Houston, Minneapolis, and Seattle. (Kowalczyk, 5/9)

Social smokers 聽smoke occasionally and almost always in groups. They don't consider themselves addicted to nicotine and don't have a daily habit, researchers said. But their risk for high blood pressure and high cholesterol is identical to those who light up every day, new research has found. (Farkas, 5/9)

Women鈥檚 Health

Week Of Anti-Abortion Movement Wins Buoys Supporters, Mobilizes Opponents

The Associated Press tallies the new momentum for foes of abortion on the federal and state level. Meanwhile, news outlets report on related developments out of Kansas, Texas, Delaware and Iowa.

From the U.S. Capitol and the White House to far-flung battlegrounds in Arizona, Iowa and elsewhere, it's been a dramatic fortnight in the debate over access to abortion and birth control. Foes of abortion celebrated a series of advances and claimed new momentum, as abortion rights supporters mounted protests to try to blunt it. Planned Parenthood, the anti-abortion movement's prime target, called it "the world's worst week for women's health." (Crary and Silber, 5/9)

Along with Texas, Kansas leads the nation when it comes to imposing abortion restrictions not supported by scientific evidence, according to a report by a leading abortion rights organization. The Guttmacher Institute looks at 10 categories of abortion restrictions it says are not grounded in science. The analysis finds that Kansas and Texas have enacted laws in all 10 鈥 although courts have blocked the restrictions in two of those categories: requirements that abortion clinics meet the standards for ambulatory surgical centers and that doctors have admitting privileges at nearby hospitals. (Margolies, 5/9)

The state Senate has narrowly passed a bill to ensure abortion remains legal in Delaware if the U.S. Supreme Court ruling in Roe v. Wade is ever overturned. The bill, approved Tuesday and sent to the House, revises Delaware鈥檚 current abortion law, which is still on the books despite being superseded by federal law. (Chase, 5/9)

The Iowa Supreme Court has extended a temporary injunction that suspends part of a new law that mandates a three-day waiting period before an abortion. When Planned Parenthood and the ACLU first asked for the injunction last week, they argued that the Iowa Department of Public Health had not yet developed certain materials which the new law mandates women be provided before having an abortion. (Boden, 5/9)

State Watch

Maryland Governor Selects Obamacare Critic To Lead State's Health Care Commission

Robert E. Moffit is a senior fellow at the Heritage Foundation who advocates for full repeal of the Affordable Care Act. He has been on the Maryland panel commission since 2015.

Maryland Gov. Larry Hogan (R) on Tuesday appointed a leading critic of the Obama administration鈥檚 Affordable Care Act to chair the state鈥檚 health-care commission, drawing immediate criticism from Democrats. Robert E. Moffit has served as a member of the commission, which oversees hospitals and health care in the state, since 2015. A senior fellow at the conservative Heritage Foundation, he has called for a full repeal of the federal health-care law, promoted Medicare vouchers and applauded the controversial health-care bill that House Republicans passed last week. (Hicks, 5/9)

Gov. Larry Hogan has appointed Robert Emmet Moffit, a critic of Obamacare who has called for the repeal of the health care law, to chair the Maryland Health Care Commission. Moffit is a senior fellow at the Center for Health Policy Studies at the Heritage Foundation, the conservative think tank in Washington. In February, he wrote a paper for the foundation calling Obamacare "a proven policy failure" and urged the administration of President Donald Trump and Congress to "completely repeal" it. (McDaniels, 5/9)

State Highlights: D.C. Zika Testing Program Botched Results; Ga. Gov. Signs Optometry Bill But Also Issues Related Executive Order

Media outlets report on news from Washington, D.C., Georgia, Arizona, Colorado, New Jersey, Florida, Ohio, Massachusetts, Louisiana and Wisconsin.

Three people in the District were wrongly told they did not have the Zika virus last year, and 26 others who may have been infected were mistakenly given a clean bill of health, according to the final accounting of results botched by the city鈥檚 public health lab, officials say. At least one of the three who did not know she had the virus was pregnant at the time. She has since given birth, and the baby did not have microcephaly, the severe birth defect caused by Zika and characterized by an abnormally small head size and often an underdeveloped brain. (David, 5/9)

Gov. Nathan Deal took an extra look at a bill that expands the abilities of optometrists in the state. He signed into law Tuesday Senate Bill 153, which intitally related to hearing aids but was transformed into a bill that allows an optometrist to diagnose and treat certain eye conditions through injection 鈥 a procedure previously only ophthalmologists performed. (Baruchman, 5/9)

Four years, thousands of work hours,聽$80,000 in fundraising and a last-minute miracle later, a group of Arizona State University students聽has finished a large-scale charity project just in time for its last two members to graduate.聽Five women and one man make up聽Engineering Smiles, a group聽that designed a mobile dental clinic that will serve tens of聽thousands of people聽in Nicaragua and underserved communities in Arizona and California. (White, 5/9)

Eight years ago, Colorado created a program to give hospitals more money to cover uncompensated costs on the promise it would lower insurance rates for all. The state鈥檚 hospitals received $6.4 billion since then to cover charity care and unpaid bills from indigent patients 鈥 all money intended to reduce the cost-shift to people with private insurance. But private payers 鈥 which make up the majority of Colorado 鈥 never saw the benefits trickle down. (Frank, 5/9)

New Jersey Attorney General Christopher S. Porrino on Tuesday announced the expansion of a聽hidden-camera loan program,聽to make it available not just in private homes, but also in nursing homes and other institutional settings. The Safe Care Cam program of the New Jersey Division of Consumer Affairs, started in December to help people who suspected that their loved ones were being mistreated or neglected, allows state residents to borrow free micro-surveillance equipment to keep an eye on loved ones. The state is not disclosing how many of the cameras it purchased or how many are in use. (Brubaker, 5/9)

Two deaf patients from Miami won the right to sue Baptist Health South Florida for discrimination after a federal appeals court on Monday reversed a lower court鈥檚 dismissal of their case 鈥 and published a detailed opinion that advocates say spells out the responsibility for all hospitals to ensure 鈥渆ffective communication鈥 with patients who cannot hear. The patients, Cheylla Silva and John Paul Jebian, filed a lawsuit in 2014 under the Americans with Disabilities Act after they said Baptist Hospital Miami and South Miami Hospital 鈥 both owned by Baptist Health 鈥 had refused to provide in-person interpreters of American Sign Language. (Chang, 5/9)

A new report shows that the quality of Ohio鈥檚 nursing homes is lower than the national average, though the reason is unclear. The report, by the Scripps Gerontology Center at Miami University, looked at residents who stay in a facility for 100 days or more. It showed that Ohio ranked below the national average on all 10 of the quality measures used by the Centers for Medicaid and Medicare Services, including instances of urinary tract infections, unexplained weight loss, pain, pressure ulcers and use of antipsychotic medications. (King, 5/10)

Disabled Massachusetts residents are about to get their own version of a college savings plan: a tax-free account that lets families set aside up to $14,000 a year for an array of expenses ranging from health care to education, without losing federal disability benefits. It鈥檚 a national program some eight years in the works, and the culmination of a tireless effort by families to make their case to Congress. (Healy, 5/10)

Those experiences suggest that the price of an office visit - likely the simplest and most common encounter patients have with the health care industry - is far more complicated than most people anticipate. Perhaps because patients know what they paid for office visits in years past, concerns over their rising prices came up over and over. The effort required to comprehend those prices is emblematic of the snarled system of health care billing. 聽(Lipinski, 5/10)

Gov. Nathan Deal signed into law Tuesday a measure that expands the state鈥檚 medical marijuana program. Senate Bill 16 makes six more conditions eligible for treatment with a limited form of cannabis oil allowed in Georgia: AIDS, Alzheimer鈥檚 disease, autism, epidermolysis bullosa, peripheral neuropathy and Tourette鈥檚 syndrome. It also allows patients in hospice care to possess the oil. (Baruchman, 5/9)

With livestock-contamination of drinking water a growing concern in Wisconsin, the Department of Natural Resources has quietly started efforts to provide temporary water supplies to people with tainted wells. The DNR posted an update on its website in April that said it would provide temporary emergency drinking water when tests show that a water supply is contaminated and is likely due to groundwater contaminated by manure, a person on the property contracts a water-borne illness or there is a sudden change in color or odor of well water. (Bergquist, 5/9)

With retail pot shops set to open next year in Massachusetts, advocates are worried that medical cannabis patients could be forced to pay higher prices for the drug, lose access to specialized preparations, or simply end up marginalized among the coming flood of recreational users. To ensure medical marijuana lasts, proponents are lobbying for changes that include making it easier and cheaper to register as a patient, guaranteeing a steady supply of marijuana just for patients, and encouraging investment by allowing nonprofit medical dispensaries to convert to for-profit businesses. (Adams, 5/9)

Prescription Drug Watch

Money-Back Guarantees Protecting Patients From Buying A Lemon When It Comes To Pricey Drugs

News outlets report on stories related to pharmaceutical pricing.

Warranties and money-back guarantees, long used to entice buyers of products like hand tools and kitchen gadgets, are now being used to sell something more crucial: pricey new-generation drugs for diseases like rheumatoid arthritis and cancer. Deals being negotiated between drugmakers and the insurers who buy medicines now sometimes include extra rebates 鈥 or even full refunds 鈥 if drugs don鈥檛 help patients as expected. (Johnson, 5/3)

[Pharmacy-benefit managers] occupy a key crossroads of the health system, acting as a nexus among insurers, employers and drug companies. Through a complex web of agreements they help decide what drugs are covered by a patient鈥檚 insurance, and how much they鈥檒l cost at the pharmacy counter. The problem, say critics, is that opacity makes it hard for employers to know how much the PBM is paying and profiting on each transaction -- an impression reinforced by restrictions on who can audit them and how. (Weinberg and Langreth, 5/4)

A new California bill aims to reduce the pharmaceutical industry鈥檚 influence in medical decision-making by restricting payments and gifts from drug companies to doctors and other medical providers. State Sen. Mike McGuire (D-Healdsburg), who authored the bill, said that when drugmakers woo physicians with meals and other enticements they generate brand loyalty, which can raise health care costs and even compromise patient safety. (Bartolone, 5/10)

True to its word, the pharmaceutical industry trade group has revised its membership criteria in a bid to deflect stinging criticism that too many drug makers aggressively raise prices, but issue empty promises about investing in research and development to produce needed medicines. Going forward, companies will now have to invest an average of 10 percent of global sales on R&D and spend at least $200 million annually on R&D over a three-year period, in order to be a member of the Pharmaceutical Research & Manufacturers of America. (Silverman, 5/9)

In a significant shift, total spending on medicines in the US rose by 5.8 percent, to $450 billion, in 2016, which was less than half the rate seen in the last two years. In 2015, for instance, drug spending climbed 8.9 percent and聽it had rocketed up by 12 percent the year before. (Silverman, 5/4)

The Senate HELP Committee added language addressing drug importation and complex generics to the FDA user fee reauthorization bill it is scheduled to mark up Wednesday. Both issues have been portrayed in recent months as ways to address high drug costs. (Karlin-Smith, 5/8)

The newest multiple sclerosis drug could be a boon for patients 鈥 and a threat to the multibillion-dollar business of Biogen Inc., the leading seller of MS treatments... While it鈥檚 too early to project Ocrevus sales, there鈥檚 little doubt it could pose a tough challenge for Cambridge-based Biogen. (Weisman, 5/8)

The quest to cure multiple sclerosis, or even to discover its cause, has remained elusive. But in March, the U.S. Food and Drug Administration approved a new drug to treat the most severe form of the disabling neurologic condition, which causes the body鈥檚 immune system to malfunction, attacking the cells of the spinal cord and brain.聽聽MS affects more than 450,000 people 鈥 more often women 鈥 in the United States. The new drug, Ocrevus, has been hailed by researchers and physicians as a game-changer, with the potential to lead to new avenues of treatment for other diseases, as well. (Bauers, 5/8)

It is one of the most acute indignities of being uninsured in this country: Those with the least ability to pay are asked to spend the most for their prescription drugs. That鈥檚 because people without health insurance are forced to pay the list price for brand-name drugs, while insurers have access to a lower, negotiated rate for the same products. (Thomas, 5/8)

n a bid to defuse sharp criticism of prescription drug pricing, the nation鈥檚 largest pharmacy benefit manager, Express Scripts, and several pharmaceutical companies are teaming up to offer discounts on more than three dozen brand medicines. The program, called InsideRx, is geared primarily to聽patients who lack insurance or who have high-deductible health plans, and offers average discounts of 34 percent on medicines for treating diabetes, high cholesterol, acid reflux, and respiratory problems such as asthma. (Silverman, 5/9)

In the latest effort to respond to criticism over drug pricing, Sanofi says it will limit price hikes to a level at or below the medical rate of inflation in the US, which is projected to reach 5.4 percent this year. And like other companies, the drug maker released recent price increases 鈥斅燽efore and after rebates paid to middlemen 鈥攁nd vowed to continue doing so in the future. (Silverman, 5/9)

After weeks of anticipation, PTC Therapeutics has decided to charge $35,000 a year 鈥攄epending upon patient weight 鈥斅爁or a newly purchased drug for treating Duchenne muscular dystrophy, although the price may be a hard sell to some insurers and families. The pricing is well below the $89,000 that Marathon Pharmaceuticals planned to charge before selling the decades-old steroid last month to PTC. But whether this lower price is enough to assuage parents or make it worth the $140 million purchase 鈥斅爌lus royalties and other payments 鈥斅爄s unclear. (Silverman, 5/8)

PTC Therapeutics Inc. said聽Monday聽that it would receive a net price of $35,000 annually per patient for Emflaza, the muscular dystrophy drug it acquired from Marathon Pharmaceuticals LLC last month.PTC didn鈥檛 explain how it calculated the 鈥渘et price,鈥 a term drugmakers sometimes use to describe the net revenue they receive for a drug after providing discounts, copay assistance and free medicine to patients without insurance. PTC said the $35,000 鈥渘et price鈥 reflected how much it expected to receive from a typical pediatric patient weighing 25 kilograms, or about 55 pounds. (Walker, 5/8)

There鈥檚 widespread interest, all the way up to the Oval Office, in driving聽down prescription drug prices. Where things tend to get聽stickier, policy wonks say, is in finding a way to do it that doesn鈥檛 discourage drug companies from spending聽big on research. To try to generate fresh ideas that strike the聽right balance, the Washington think tank Brookings Institution commissioned a set of three white papers from top scholars. They were released this week. (Robbins, 5/4)

The Ohio Drug Price Relief Act, a citizen-initiated statute slated for the November ballot, would require the state of Ohio to pay no more聽for prescription drugs than the U.S. Department of Veterans Affairs, which has negotiated a discount of up to 40 percent. The reason people think the campaign will be so costly is that last year, more than $128 million was spent on a similar (and ultimately unsuccessful) ballot measure in California. (Pelzer, 5/2)

Perspectives: When Drug Prices Are High Patients Take Fewer, Leading To More Expensive Care

Read recent commentaries about drug-cost issues.

Many studies have demonstrated what economics theory tells us must be true: When consumers have to pay more for their prescriptions, they take fewer drugs. That can be a big problem. For some conditions 鈥 diabetes and asthma, to name a few 鈥 certain drugs are necessary to avoid more costly care, like hospitalizations. This simple principle gives rise to a little-recognized problem with Medicare鈥檚 prescription drug benefit. (Austin Frakt, 5/8)

Colon cancer is one of the biggest killers in the developing world. The disease claims more than 600,000 lives every year. Breakthrough treatments can contain this disease and dramatically extend life. However, many colon cancer patients are currently denied access to these breakthrough treatments because of short-sighted government policies. (Andrew Spiegel, 5/5)

For more than a year now, every time the biotech IPO window has seemed to open a crack it has rapidly聽slammed shut. But a recent surge of deals and a period of relative stability in the market suggest this time might be different. Last year saw the smallest number of biotech IPOs since 2012 -- 36 offerings that raised about a third of what 2014 or 2015's bumper crops raised. But things appear to be looking up. The second quarter is less than halfway over, and already new companies have raised nearly as much money as they did in any quarter in 2016. (Max Nisen, 5/9)

America is the undisputed leader in biopharmaceuticals and medical innovation, at least for now. In countries around the world, governments are taking steps to weaken their U.S. competitors while advancing their own domestic industries 鈥 hampering continued investment in innovative new therapies for patients. This is why it is so vital that America鈥檚 trade negotiators ensure that we enter into deals with true reciprocity and tough enforcement 鈥 something echoed by both the recently released Special 301 Report and President Trump鈥檚 April 29 executive order targeting trade abusers. We are happy to compete on a level playing field, but we have to do so with our eyes wide open 鈥 recognizing that other countries may not always share our commitment to fair play. (Stephen J. Ubl, 5/4)

There is no doubt that the increasingly globalized nature of trade within the United States and around the globe has opened the door to an expansive number of goods and services for consumers. In fact, the growth of globalization has encouraged some policymakers to suggest that importation of prescription drugs would be a worthwhile opportunity for millions of Americans. (George Karavetsos, 5/6)

Editorials And Opinions

Contemplating GOP Health Plan Politics: Can The Senate's Panel Of White Men Come To The Rescue?; Who Voted How And Said What?

Editorial writers take on the optics involved as Senate Majority Leader Mitch McConnell (R-Ky.) taps a group of Republican senators to craft a repeal-and-replace package, and handicap the reasons behind some representatives' votes in the House, if they will be held accountable and what could happen next.

I know there aren鈥檛 that many women in the U.S. Senate. Just 21 of the 100 U.S. senators are female, and probably some of them had other plans. But still, couldn鈥檛 Senate Majority Leader Mitch McConnell (R-Ky.) find one woman to join the 13 men on his Obamacare overhaul posse? Just one? True, most of the women in the Senate are Democrats and would probably be annoying about pap smears, mammograms and Planned Parenthood. They might also point out that the Republican鈥檚 plan to replace the Affordable Care Act will invariably affect women. Women have a higher rate of poverty than men. (Mariel Garza, 5/9)

Is there an Obamacare provision for self-inflicted wounds? If so, Senate Republicans should file a claim pronto before they repeal and replace the offending legislation. It鈥檚 hard to understand how the GOP leadership could run head-first into such an avoidable misstep. They appointed 13 members to the Senate health care working group last week, either not noticing or not caring that all 13 of those senators are white men. (Patricia Murphy, 5/10)

When House Republicans passed the American Health Care Act on May 4, President Trump bullishly predicted that the bill would pass the Senate and arrive at his desk to be signed into law聽鈥 though the timeline for the bill's passage is unclear. 鈥淲e're going to get this passed through the Senate,鈥 he said, surrounded by beaming GOP congressmen. 鈥淚 feel so confident.鈥 (Peter W. Stevenson, 5/9)

Coongressman Mo Brooks, R-Ala., of the conservative House Freedom Caucus, recently implied that "people who lead good lives" do not have pre-existing conditions. I lived a very good life by most standards. I never drank. I never smoked. I exercised. Yet at age 35, while pregnant with my third child, I was diagnosed with Stage 2 breast cancer. It was an aggressive cancer, and treatment could not be delayed. Chemotherapy was started while I was pregnant. After my baby was born, I had both my breasts surgically removed, followed by surgery to remove my ovaries. Genetic testing showed I carried a mutation (BRCA), which increases my risk of breast, ovarian and other cancers. Born with this mutation, I have a 50 percent chance of passing it to my children 鈥 through no fault of mine or theirs. (Sarah Nadeem, 5/9)

Joyce's stated reasons were sound, grounded in concern about the well-being of Ohioans. As he wrote on Twitter, "The idea that premiums could potentially skyrocket for people with pre-existing conditions and increase three to five times for people nearing retirement is something I find unacceptable." Joyce, of Geauga County's Bainbridge Township in Geauga County, also said he was troubled by the bill's threat to funding for opioid addiction treatment. (5/10)

There鈥檚 no issue before Congress more crucial than healthcare. So why would two Miami-Dade lawmakers whose constituents heavily rely on the affordability of Obamacare for their health insurance vote to repeal the Affordable Care Act? Partisan politics, ambition, and deal-making maybe. (Fabiola Santiago, 5/9)

Barack Obama emerged from his short-lived political retirement on Sunday to call on Members of Congress to show the 鈥減olitical courage鈥 to preserve ObamaCare. But wait. That plea doesn鈥檛 square with the deluge of recent stories predicting that Republicans have doomed their majority in 2018 by voting last week to repeal Obamacare. (5/9)

Different Takes: Obamacare's Impact On Families' Financial Health; Can Washington Get Health Care Right?

News outlets' editorial sections highlight policy issues in play as the debate over the GOP health plan continues.

Here鈥檚 another benefit of the Affordable Care Act you may not have read much about, but is profoundly threatened by the Republican repeal effort: It has reduced the tide of healthcare-related personal bankruptcies. That鈥檚 the finding of a recent survey published by Consumer Reports, based on a poll of 2,000 consumers conducted this year and statistics showing that personal bankruptcy filings have fallen from more than 1.5 million in 2010 to 770,846 last year. (Michael Hiltzik, 5/9)

A recent article in Consumer Reports said that the Affordable Care Act, better known as Obamacare, has helped reduce personal bankruptcies, which have fallen by about half since 2009. The article also cites a bankruptcy lawyer who reported a dramatic decline in the number of clients who turn to the courts because they鈥檙e unable to pay their medical bills. It鈥檚 important to take conclusions like this with a grain of salt. There were other factors that probably had a lot to do with the fall in personal bankruptcy. ... Still, it would be a mistake to discount the ACA. (Noah Smith, 5/9)

In March, when House Speaker Paul Ryan and his fellow Republicans threatened to repeal the Affordable Care Act, I pulled a pussyhat over my infant son鈥檚 bald head, fetched my 6-year-old daughter from school and raced to a pop-up protest at the Capitol. The sign I鈥檇 quickly made wasn鈥檛 artful, but it was sincere: 鈥淚 am a postpartum R.N. This bill is bad for mamas and babies. Vote no!鈥 (Kyla Nguyen, 5/9)

If the 2016 election was a rejection of incrementalism as asserted in this space last year, then Republicans should fear what will happen to their governing trifecta should they fail to repeal and replace Obamacare. Failure is not an option in dealing with the Kobayashi Maru brought on by Obamacare. Republicans must get this right not just because of their campaign promises, but because of the underlying fiscal problems Obamacare has wrought on the budgets of working families and state governments. (Scott Jennings, 5/9)

To see what House Republicans are really up to, start with Medicaid 鈥 and common sense. They would reduce Medicaid spending by some $880 billion over a decade. The program鈥檚 federal expenditures run about $550 billion a year. You simply can鈥檛 make a cut of that magnitude without major consequences. ... Republican governors understand the dilemma all that would present and are voicing their concerns. And unlike the House, Senate Republicans may just take those matters seriously. That鈥檚 encouraging 鈥 even if one suspects their biggest worry is for their own political health. (Scot Lehigh, 5/9)

The American Health Care Act strips coverage from millions of struggling Americans. It would let states flee not only from Obamacare鈥檚 mandatory coverage of minimum, essential benefits聽but its requirement to cover preexisting conditions as well. States could herd sick people into high-risk pools, which would be underfunded, if the real-world experience聽that conservatives used to prize is any guide. (Rich Barlow, 5/10)

With any health care system, it is critical we thread the needle of compassion and reality. As a doctor, providing options for the most vulnerable isn鈥檛 just a talking point, it鈥檚 been my job description for over 26 years. But the reality today is one-third聽of U.S. counties have only one company left offering insurance on the ACA exchanges. (Brad Wenstrup, 5/9)

Americans simply don鈥檛 want to face the harsh reality that, like any other good or service, health care is finite and must be rationed. If it is not rationed through prices set by the marketplace, it will be rationed through rules set by the bureaucracy. At some point, one or the other is going to say no. And that鈥檚 the one word nobody in politics is ever allowed to say. (A. Barton Hinkle, 5/9)

Viewpoints: The Link Between Despair And The Opioid Crisis; Big Tobacco And E-Cigarettes

A selection of public health opinions from around the country.

Addiction thrives when people and communities don鈥檛. That鈥檚 the essential lesson of a recently released聽Brookings Institution study聽that has deep implications for how our nation will address its opioid crisis. We assume that life expectancy will continue to improve in the United States. Yet this study found that the death rate of non-Hispanic whites between the ages of 45 and 54 who don鈥檛 have a college degree has increased by half a percent every year from 1999 to 2013. What鈥檚 going on? One key contributor that the researchers cite is a rise in the number of 鈥渄eaths of despair鈥 鈥 deaths from drugs, alcohol, and suicide 鈥 that can be traced to waning economic opportunities and a frayed social fabric. In other words, deaths that spring from lack of hope, purpose, and opportunity. (Manal Aboelata, Larry Cohen and Sheila Savannah, 5/9)

Harm reduction encompasses strategies aimed at reducing harmful physical or social consequences that stem from legal and illegal behaviors. It accepts that individuals will engage in potentially risky behaviors, and so aims to minimize their impact. Examples of harm reduction strategies include providing methadone to heroin users, endorsing the use of condoms to prevent pregnancy and the spread of sexually transmitted diseases, opening needle exchanges to prevent the spread of HIV and hepatitis among individual who inject drugs, and promoting e-cigarettes or smokeless tobacco as alternatives to smoking combustible cigarettes. Harm reduction interventions reduce some, but not all, of the short-term and long-term risks for any given behavior. It is not necessarily inconsistent with the goal of total cessation or abstinence, but that isn鈥檛 its main priority. (Amy Fairchild and Ronald Bayer, 5/8)

Jennifer Evans鈥 tweet shot through the Twitter clutter. 鈥淏eing a cancer mom is tough, but nothing like what my son is going through. I pray we can get cannabis legalized here in NC!!鈥 In late 2015, a month before his 14th birthday, Aaron Evans was diagnosed with a brain tumor. Imagine it was you hearing the words, 鈥淕rade-three anaplastic astrocytoma,鈥 and the brain scan you see was your son鈥檚 or daughter鈥檚. Your entire being would be fired with the passion to do whatever it would take to save your child鈥檚 life 鈥 which is exactly what Jennifer Evans did. (Keith Larson, 5/9)

In my 20s, I was neutral about parenthood partly because, as a woman with cerebral palsy, I was spared the usual intrusive questioning and expectations about having children that most women are subject to. People never pressured me to have children; they just assumed that I could not. In fact, it became clear very fast that women like me are expected not to reproduce. Now, in my 40s, I find these attitudes ignorant and prejudicial, but as a young woman, it seemed like a bit of freedom to be excused from the usual problems women complain about. (Jennifer Bartlett, 5/10)

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