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Alex Azar, President Trump’s pick to serve as Health and Human Services secretary, represents everything wrong with the incestuous relationship that often exists between government officials and the industries they oversee. This is a guy who, after being active in George W. Bush’s presidential campaign, landed a plum job with the Department of Health and Human Services despite being a lawyer with no background in healthcare. (David Lazarus, 11/15)

President Donald Trump announced Monday he is nominating former pharmaceutical executive Alex Azar as secretary of Health and Human Services. Azar would fill the Trump administration position vacated by Tom Price, who resigned in September amid criticism of his use of private planes as HHS secretary. Under President George W. Bush, Azar served as HHS general counsel and deputy secretary. He stepped down as president of the U.S. affiliate of pharmaceutical giant Eli Lilly in January. Trump tweeted Monday that his HHS secretary pick would "lower drug prices." (Hayley Hoefer, 11/13)

Two immense problems plague the prescription drug marketplace: The costs of prescription drugs are spiraling out of control, and few people are able to access accurate information about drugs’ effectiveness, safety, or side effects, all of which are needed for wise use of these drugs. Pharmacy benefit managers (PBMs) are contributing to the cost problem and failing to address the information problem. (Linda Cahn, 11/15)

Drug companies are always figuring out creative ways to sustain high prices on brand-name medications. In the latest twist, Allergan this fall transferred the patents covering its eyedrop Restasis to the sovereign St. Regis Mohawk Tribe, admitting outright that its goal was to prevent the patents from being overturned. (Carrier, 11/14)

Some ideas are bad. Others are simply terrible. A group of congressional lawmakers has found a way to put military personnel at risk and undermine regulatory standards for approving medicines — all at once. Under legislation that was crafted by House and Senate negotiators, a special Department of Defense panel would be authorized to approve certain drugs and devices for emergency use when members of the armed forces confront “agents of war.” (Ed Silverman, 11/14)

Discussions on access to prescription drugs are back in vogue in the nation’s capital, where the Senate recently convened a fiery hearing on the drug delivery system and President Trump is reiterating a commitment to addressing the cost of prescription drugs. One way to rein in drug costs would be to reduce government interference in arrangements between drug makers and insurers that reward better patient outcomes and lower costs. (Joel White, 11/10)

A Consumer Reports Best Buy Drugs national telephone poll survey recently reported three fourths of Americans 65 and older currently take an average of six prescription medications. The poll also reported one third of people over 65 experienced drug costs increases during the previous 12 months and paid an average of $53.00 more for at least one of their drugs. Other drugs have increased as well. Even though Americans over 65 have insurance coverage such as Medicare, drugs continue to increase and out-of-pocket costs for drugs increase as well. Many individuals live on a fixed income feel the price pain. (Keith Miller, 11/14)

When state legislators started enacting laws in 2011 to prevent insurance companies from charging patients more for oral cancer drugs than they do for cheaper, infused medicines, the idea was to shield the public from sky-high, out-of-pocket drug costs. But a new study is raising disturbing questions about the effectiveness of these “parity” laws, which have been enacted in 43 states and the District of Columbia. (Arlene Weintraub, 11/9)

This question often comes up: At what point will we reach a critical tipping point where we can't afford to provide the therapies that we want? This is becoming a problem as we start to think about multiple combination therapies, either combinations of novel immuno-oncology agents such as checkpoint inhibitors, novel targeted agents, or a combination of targeted agents and checkpoint inhibitors. (Leonard B. Saltz, 11/9)

In May 2017, the US Food and Drug Administration (FDA) announced a Drug Competition Action Plan, designed to address competition and pricing in the generic market and improve access to prescription drugs.1 One of FDA’s stated goals is to reexamine “places where its rules—including standards and procedures related to generic drug approvals—are being used in ways that may create obstacles to generic access,” instead of ensuring the vigorous competition Congress intended. In this Viewpoint, we examine FDA’s 2006 Unapproved Drugs Initiative (UDI), designed to strengthen the agency’s regulatory oversight related to unapproved marketed drugs. Using an illustrative example, we discuss this initiative’s unintended consequences, as it appears to have created obstacles to generic drug access, likely increasing prescription drug costs. (Aaron Hakim, Ravi Gupta and Joseph S. Ross, 11/13)

In May 2017, the US Food and Drug Administration (FDA) denied a 6-month extension of market exclusivity for Sensipar (cinacalcet), a drug manufactured by Amgen to manage hypercalcemia, common among patients with end-stage renal disease who are undergoing dialysis. The FDA determined that Amgen’s pediatric studies had been conducted inadequately and had provided inconclusive safety data. Amgen brought a lawsuit, Amgen v HHS (US Department of Health and Human Services), to challenge the denial. If Amgen prevails, it can delay generic competition for 6 months for a drug that generated $1.24 billion of revenue in 2016.2 More broadly, a decision favoring Amgen could diminish the FDA’s ability to encourage clinically meaningful pediatric studies and thus undermine the purpose of Congress in offering patent extensions to reward pediatric research. (Jeanie Kim, Joseph S. Ross and Amy Kapczynski, 11/8)