The end of an era for the FDA’s longtime drug chief

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One last talk with Woodcock (for now)

It’s the end of an era for the FDA’s longtime drug chief. But she’s already got plans underway for her next chapter, and plenty of thoughts on where the agency stands in the ongoing battle for public trust.

In a far-ranging interview with STAT just days before her retirement from more than three decades at White Oak, Janet Woodcock talked about the “flexibility” federal officials need to take on as science and society evolve, her future plans, and even some of the criticisms that have trailed CDER under her tenure.

The longtime drug division director has been a stalwart defender of accelerated approval pathways, for instance, though she acknowledged that changes are underway to bulk up post-marketing requirements. And while she won’t talk about the looming mifepristone decision, Woodcock said there’s a culture shift that scientific authorities need to address. Read the whole interview.

Ready, set, argue

Lawyers for AstraZeneca and the government on Wednesday will make oral arguments in a lawsuit against Medicare’s new power to negotiate drug prices that could help set the tone for several similar legal challenges.

My colleague John Wilkerson will provide a dispatch from the federal court in Delaware where the oral arguments will take place. This is the second such lawsuit to reach the oral argument stage – there are nine lawsuits aimed at stopping Medicare from negotiating drug prices. Lawyers for pharma ally U.S. Chamber of Commerce argued their case in September. The Trump-appointed judge in that case rejected the Chamber’s request to stop work on the program while he weighs whether it’s constitutional.

Like the Chamber, AstraZeneca argues that the negotiation program deprives drug companies of their right to sell products at prices that are free from government meddling. The company also is asking the judge, also a Trump appointee, to cancel certain guidelines for implementing the program. If AstraZeneca were to win that procedural argument, it could delay Biden’s signature health care achievement from taking effect.

It’s a big week for Medicare’s drug pricing powers — the government is set to make its initial pricing bids for the first 10 drugs on Thursday. (Rachel had more on that in last week’s newsletter, here.)

A health-filled March for SCOTUS

The Supreme Court will hear two major cases questioning federal health authorities this spring, setting up for a showdown on both Covid-19 policies and abortion access.

The first, Murthy v. Missouri, is before the court on March 18. At the core of this lawsuit is whether the federal government’s requests for social media and search giants like Google, Facebook, Twitter and YouTube to moderate Covid-19 misinformation violated users’ First Amendment rights. A lower court already told the government they stepped outside their power, but SCOTUS paused that ruling, for now. More on what could happen, and how we got here.

The second, much-discussed case focuses on the FDA’s regulation of the abortion pill mifepristone. Advocates on both sides of the suit have agitated for SCOTUS to take up the case, which will be the first major test of abortion limits since the same panel overturned Roe. The court could side with appeals judges who struck down a Biden move to allow mail-order mifepristone—or they could challenge the original approval, throwing FDA authority into question. More from me.

ICYMI: Drugmakers agree to Senate testimony

Merck CEO Robert Davis and Johnson & Johnson CEO Joaquin Duato have agreed to voluntarily testify before the Senate health committee, avoiding a threatened subpoena, the committee announced Friday.

The decision by the executives came after a public pressure campaign by Sanders to get the two executives and Bristol Myers Squibb CEO Chris Boerner to testify about why prices for their drugs are higher in the United States than in other countries, Rachel Cohrs writes.

The companies had protested that the hearing was retribution for their decisions to sue the Biden administration over Democrats’ new Medicare drug price negotiation program, and offered executives other than the CEO to testify. Several other pharmaceutical companies and trade associations have also filed lawsuits against the law that established the program. More from Rachel.

What we’re reading

• From a small town in Wales, a scientific sleuth has shaken Dana-Farber — and elevated the issue of research integrity, STAT
• Andrey Shevelyov would rather live on the street than take antipsychotic medication. Should it be his decision to make? The New York Times
• A call to add sexual orientation and gender identity data to electronic health records, STAT
• Pa. Supreme Court grapples with question of whether abortion access is protected by state constitution, The Philadelphia Inquirer