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Early 👀 lobbying reports, tobacco companies’ campaign cash, and a heated debate about accelerated approval

   

 

D.C. Diagnosis

Hello and happy Thursday, everyone! We’re less than three weeks out from Election Day, and we are on the lookout for any interesting health- and science-related ads you see popping up on your social media feeds or television screens (or, more likely, those of your friends and relatives in Georgia, Pennsylvania, Wisconsin, or Nevada, where there’s a little more excitement on the ballot). Drop a line anytime to rachel.cohrs@statnews.com.  

The cost of a big drug pricing reform law

AARP was one the most vocal proponents of the legislation Democrats passed in August to let Medicare negotiate drug prices. Turns out there was money behind that support: the seniors’ group dropped a whopping $4.79 million on their lobbying activity between July and September, according to STAT’s review of new federal filings. They spent $2.9 million in the same quarter back in 2021. 

More reports are still trickling in today, but that figure’s likely to make them among the top 10 highest spenders in the country, based on past quarters. AARP employs 20 registered lobbyists, and its filing shows that in addition to the Inflation Reduction Act, the group pressed lawmakers about a whole host of other Medicare- and Medicaid-related issues. (If you haven’t read it, former DCD author Nicholas Florko wrote a great profile of their aggressive advocacy strategy.)

It’s not clear yet if the pharmaceutical industry spent wildly to fight back: Amgen’s spending did go up to $3.15 million last quarter, a boost from the $2.62 million it spent in Q3 2021, but Eli Lilly’s dropped, from $1.3 million down to $1.2 million. We’ll keep our eyes peeled for the filings from PhRMA, BIO, and any other eyebrow-raisers as they come in.

The complicated politics of tobacco 

Rep. Donald McEachin (D-Va.) (Chip Somodevilla/Getty Images)

What do the majority of Democrats receiving campaign checks from the maker of Newport cigarettes this election cycle have in common? They’re Black.

In a new story for STAT, my colleague Nick Florko digs into the latest federal election data to track how cigarette makers are targeting Black Democrats just as those same companies are rallying opposition to the FDA's plan to ban menthol cigarettes, which are overwhelmingly preferred by Black smokers. 

The statistics are striking: Reynolds American, the maker of Newport cigarettes, gave to only 17 Democrats this election cycle, 13 of whom are Black. 

For more, check out Nick’s story here

A heated debate over accelerated approval and racial equity

A key FDA advisory panel told the agency to pull from the market a drug for preventing premature births, after an extraordinary three-day hearing — one that had major implications for the increasingly controversial accelerated approval program. 

As my colleague Ed Silverman reports, the hearing came amid growing questions about whether the accelerated approval program is living up to its promises, especially as confirmatory studies take longer than expected to complete and some follow-up trials fail to demonstrate expected benefits. It’s also raising questions about whether the FDA has the power to really enforce the terms of the program. 

The company behind Makena, however, pitched the issue as a broader one of racial equity: The company argued the initial approval trial was conducted in the U.S. with nearly 60% of Black participants, but the required confirmatory trial was international in scope with mostly white participants. It says Makena may therefore work for Black women and that it should be kept on the market to help the Black community and improve racial equity in the United States.

It’s not over yet: the FDA doesn’t have to follow its advisory panels’ advice, and it could take up to 6 months to decide what to do next. More from Ed, here

(And I’ll also highlight this new op-ed on the subject, from Mikkael A. Sekeres, the former chair of the FDA’s Oncologic Drugs Advisory Committee, on ‘What the Makena vote means about accelerated approval, trust, and the FDA.’) 

What we’re reading 

  • Large insurer’s decision to cover some prescription digital therapies may be a milestone for app makers, STAT
  • Covert network provides pills for thousands of abortions in U.S. post Roe, The Washington Post

  • In new White House plan, Biden administration outlines ambitious strategy to prevent and prepare for pandemics, STAT

  • Half the world has a clitoris. Why don’t doctors study it?, The New York Times 

  • FDA, DOJ sue 6 vape shops for ignoring warnings about selling illegal products, STAT

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Thanks for reading! More next week,

Rachel Cohrs

Thursday, October 20, 2022

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