Morning Briefing
Summaries of health policy coverage from major news organizations
Are Social Media Influencers Boosting Pharma Sales? The FDA Wants To Investigate
In 2015, Kim Kardashian promoted a morning-sickness pill to her millions of followers on social media, boosting sales by 21% over just a few months, a high-profile example of how so-called influencers can hold sway over the public at large. But given that there are countless influencers lurking on social media 鈥 some of whom are celebrities, others are lesser-known cheerleaders 鈥 the Food and Drug Administration plans to study the extent to which these paid endorsements affect consumers who take prescription medicines. (Silverman, 1/28)
The majority of Americans have health insurance that includes coverage for prescription drugs. But unfortunately that doesn't ensure that they can afford the specific drugs their doctors prescribe for them. In fact, many Americans report that their insurance plans sometimes don't cover a drug they need 鈥 and nearly half the people whom this happens to say they simply don't fill the prescription. That's according to a poll released this month on income inequality from NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health. (Neighmond, 1/27)
Presidential candidates can鈥檛 stop talking about insulin. At a campaign stop here on Sunday, Sen. Amy Klobuchar retold the now-familiar story of Alec Smith, whose highly publicized death from insulin rationing in 2017 sparked nationwide outrage. Sen. Elizabeth Warren, who has vowed to lower the drug鈥檚 price on her first day in office, lambasted Eli Lilly, one of just three U.S. insulin manufacturers, at an Iowa rally the day before. And since July, when Sen. Bernie Sanders joined a highly publicized 鈥渋nsulin caravan鈥 seeking cheaper prices in Canada, he has flooded this state with television ads that picture him brandishing an insulin vial in outrage. Even in a primary dominated by broader health care issues, insulin has emerged as particularly alluring campaign fodder for Democrats. (Facher, 1/28)
President Donald Trump has one big option to make good on his promise to slash drug prices: Tie the cost of U.S. drugs to the lower prices paid overseas. There鈥檚 only one problem. It鈥檚 too late for him to make a dent in what people pay for their prescription drugs before the election. (Karlin-Smith and Cancryn, 1/24)
Novartis reported strong sales of new drugs including gene therapy Zolgensma, a sign the company鈥檚 focus on cutting-edge medicines is starting to pay off. The Swiss pharmaceutical company on Wednesday said revenue from continuing operations rose 8% to $12.4 billion in the fourth quarter of last year, while core operating income, a measure watched closely by analysts, increased 11% to $3.46 billion. Net income fell 7% to $1.1 billion on a one-time tax charge. (Roland, 1/29)
When Global Blood Therapeutics won approval for its new sickle cell disease drug聽Oxbryta聽last year, execs predicted a 鈥減aradigm shift鈥澛爄n the way patients are treated. Now, the company is running into a common hurdle in today's聽U.S. launch paradigm鈥攑ushback聽from cost watchdog聽ICER. In a draft聽report, ICER concluded that sickle cell disease drugs from GBT, Novartis and Emmaus Medical are too expensive聽to meet traditional cost-effectiveness measures.聽To fall within one measure of cost-effectiveness鈥攂elow $150,000 per quality-adjusted life year鈥攖he聽companies would have to聽dramatically cut their prices, ICER said. (Sagonowsky, 1/27)
The Food and Drug Administration released a slew of gene therapy policies Tuesday aimed at encouraging drug makers to bring more of the medicines to market and perhaps forcing them to lower their prices. The FDA has approved just four gene therapies since 2017, and each has carried a sky-high price tag. The FDA鈥檚 most recent approval, AveXis鈥 Zolgensma, costs $2.1 million, the most expensive drug in history. (Florko, 1/28)
FDA may have to double staff reviewing gene therapies in the next five years to deal with a flood of new applications, a senior official said today as the agency issued final policy guidances on gene therapy manufacturing and clinical development. The agency has received more than 900 investigational new drug applications for gene therapy, said Peter Marks, director of FDA鈥檚 Center for Biologics Evaluation and Research. (Allen, 1/28)
In some towns, it is getting harder to pick up your blood-pressure pills with that gallon of milk and rotisserie chicken. Hundreds of regional grocery stores in cities from Minneapolis to Seattle are closing or selling pharmacy counters, which have been struggling as consumers make fewer trips to fill prescriptions and big drugstore chains tighten their grip on the U.S. market. (Terlep and Kang, 1/26)
Biotech earnings season kicks off Thursday with fourth-quarter reports from Alexion Pharma (ALXN), Amgen (AMGN), Biogen (BIIB), and Vertex Pharma (VRTX). That鈥檚 a full day 鈥 and meaningful because all four companies will be providing investors with their financial outlooks for 2020. 鈥淯nsettled鈥 might be the best way to describe sentiment at the start of the year. The gathering of the biotech tribe for the annual J.P. Morgan Healthcare confab聽came and went without any significant deal-making or buyouts. Global markets are being roiled by the coronavirus outbreak in China. The biotech sector鈥檚 most closely followed stock index is down 4%. (Feuerstein, 1/28)
The number of class-action lawsuits claiming securities fraud committed by life sciences companies climbed to a new high last year, continuing a trend in which drug and device makers remain attractive targets for investors, according to a new analysis. A total of 97 such lawsuits were filed against life sciences companies in 2019, a nearly 13% rise from the 88 lawsuits filed the year before. Looked at another way, almost 1 out of 4 of all securities fraud class action lawsuits were filed against these companies, a 3.7% increase from 2018, when only 1 out of 5 such actions were filed against drug and device makers. (Silverman, 1/28)
Lowering health costs emerged as a major part of Gov. Gavin Newsom鈥檚 2020 agenda earlier this month when he unveiled plans to get state government in the business of selling prescription drugs. California would be the first state to create its own drug label, which would contract with existing manufacturers to produce lower-cost drugs. Newsom said he鈥檚 already in negotiations related to the plan. (Bollag, 1/27)
While Gov. Gretchen Whitmer will target fixing the roads during her State of the State address Wednesday, at least one pocketbook issue 鈥 tackling the spiraling costs of prescription drugs聽鈥斅爓ill be on the agenda as well. 鈥淲e want to show that we're taking this seriously 鈥 we know that the increase in prescription drug costs has just been skyrocketing. It's a bigger part of our budget,鈥 she said. 鈥淎nd it鈥檚 costing people in ways that are really impacting their ability to just make their rent payment or take care of their kids.鈥 (Gray, 1/29)
People will be able to pick up prescriptions at certain pharmacies in Michigan that are not staffed by an on-site pharmacist under legislation signed by Gov. Gretchen Whitmer. The measure enacted last week allows for "remote" pharmacies, which proponents support as a way to expand access to pharmacy services and improve health outcomes in rural and underserved areas. Pharmacists at "parent" pharmacies will be able to use a real-time audio and video link to review a prescription before it is dispensed by pharmacy technicians. (1/28)
An Oklahoma state senator is working to lower prescription drug prices for state employees through a newly filed bill. Sen. Paul Scott has filed Senate Bill 1901, which would replace the state鈥檚 third-party Pharmacy Benefit Managers with a direct-to-pharmacy payment system. Scott says the move could save the state millions and help lower prescription drug prices for state employees. (1/27)
The latest effort to rein in sky-high drug prices was unveiled Monday by Sen. Troy Singleton, D-7 of Delran, and calls for the creation of a drug affordability board with the authority to recommend caps on the price of certain prescription drugs it finds are excessive. A second bill would require the state Department of Treasury to seek to enter into bulk purchasing arrangements for the most-frequently needed drugs of state employees and Medicaid recipients. (Levinsky, 1/27)