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March-in mania
The White House today will take a long-awaited step to potentially broaden the government’s authority to undermine patents for medicines developed with taxpayer funding — including considering a drug’s price as one part of the framework, my co-author Sarah and I report.
The pharmaceutical industry has argued that the possibility of patents being invalidated creates instability in the funding pipeline. But it’s unclear whether the Biden administration is actually planning to use this authority at all in the next year.
Predictably, progressives celebrated today, and my colleague Sarah Owermohle asked new NIH Director Monica Bertagnolli about her opinion on how march-in rights should be used. All that and more in the full article — and stay tuned for more details later today.
Scooplet: HELP committee to hold hearing on diabetes
After grilling insulin manufacturer CEOs early this year, Senate health committee chair Bernie Sanders (I-Vt.) is planning to return to the issue of diabetes with another hearing next week, he told me in a hallway interview. (This is in addition to the SUPPORT Act hearing that my colleague Lev Facher and I also scooped. Busy people over on HELP!)
Beyond that, details are scant. Will they talk about insulin prices? Public health issues? GLP-1 drugs? Your guess is as good as mine!
Have you been invited to testify? Got prep materials to help your boss figure out what to ask? Ping me at [email protected].
Pfizer says bye bye BIO
Pfizer has become the latest in a string of pharmaceutical companies to leave an industry trade group with its planned exit from BIO, I scooped this week. It’s also a tough start for BIO’s new CEO, rare disease advocate and biotech executive John Crowley.
Pfizer is a big player in the brand-drug lobby PhRMA, and the company’s CEO Albert Bourla is PhRMA’s board treasurer. The company has also run into financial difficulties post-Covid. Revenues are plunging, and the company last month announced layoffs in Connecticut and Michigan as part of a $3.5 billion cost-cutting campaign.
“The economic situation for the industry is difficult indeed and we of course are disappointed that any company would be forced to take a break from its BIO membership. We certainly hope that when economic conditions improve, we can welcome those companies back and welcome new members to join us as well, but it in no way affects our mission of protecting patients and medical innovation in the United States,” said BIO’s Chief Public Affairs and Marketing Officer Rich Masters. Masters said he wouldn’t comment on the status of any particular member.
DeSantis’ moment to shine on health care
The GOP presidential field (minus its leading candidate) had yet another debate that toward the very end broke some new ground on health care, at least for Florida Gov. Ron DeSantis. Here’s the quick version of his main points:
- Called for price transparency in health care
- Criticized vaccine mandates
- Promised to “clean house” at the NIH, CDC, and FDA to hold officials accountable for the approval of Covid-19 vaccines
Entrepreneur Vivek Ramaswamy called for reform of the physician payment system, and to end antitrust exemptions for health insurance companies. He also:
- Called for a 10-year lobbying ban for officials after leaving government service (with a dig at former FDA Commissioner Scott Gottlieb for his position on Pfizer’s board)
- Attacked liability protections for the manufacturers of Covid-19 vaccines
FDA, meet PTO
My colleague Ed Silverman digs into what collaboration between the FDA and PTO to lower drug prices could really mean.
Patent gaming can be tough to prevent, but if the two agencies shared data, it could give the government more tools to combat it. The White House two years ago ordered cooperation, but Ed distills the challenges of that effort to get on the same page.
In other patent-related news, the FTC’s efforts to demand brand-drug makers fix their patent listings in a government registry hasn’t gone too well, Ed reports — only one company has responded, and the FTC is planning to sue other companies, including AbbVie, AstraZeneca, and GSK.
What we’re reading
- China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes, Reuters
- Stephen Hemsley, UnitedHealth Group board chair, sells nearly $113 million in stock, STAT
- The Pentagon wants to root out shoddy drugs. The FDA is in its way. Bloomberg
- Mexico’s activist ‘companion networks’ quietly provide abortion pills and support to U.S. women, STAT
Correction: This article was corrected to fix erroneous attributions of two statements made by Vivek Ramaswamy during the GOP presidential debate.