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PhRMA and BIO descend on D.C. & the latest FDA funding drama



You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox.

It’s raining biopharma execs

As the pharmaceutical industry faces down a possible defeat on its number-one, most-feared policy priority in recent years, a slew of top drug company executives will descend on the District this week, I report with my D.C. Diagnosis co-author Rachel Cohrs.

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PhRMA board executives are gathering in Washington for their regularly scheduled annual meeting, four industry sources told STAT. It’s awfully convenient timing for them to gather, as Democrats are just a few months from the deadline to enact their domestic agenda — and drug pricing’s clearly a central part of it. Companies may take their own initiative to pay a visit to Capitol Hill during their time in the swamp.

BIO will also be in town next week. Members of the group’s executive board are flying into Washington for their annual retreat and will be trekking up to Capitol Hill to meet with lawmakers, lobbyists for BIO member companies confirmed to STAT.

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Rachel will be staking out the Capitol this week, but we know our readers have many more sets of eyeballs all around town. If you see any recognizable faces wandering the halls of Congress this week or out and about, shoot us a message and let us know who you spot!

In other drug pricing news: 25 progressive drug pricing groups and a slew of individual patients wrote to Senate Majority Leader Chuck Schumer (D-N.Y.), raising concerns that the Senate’s latest drug pricing bill doesn’t include a cap on how much people can pay for their insulin and doesn’t allow the health department to negotiate over the price of insulin.

Making sense of the user fee drama

If you follow the FDA closely, your heart probably sank on Thursday when Sen. Richard Burr (R-N.C.), the lawmaker perhaps most known across Washington for antagonizing the agency, effectively pulled his support for the Senate’s massive user fee reauthorization package.

In a new story for STAT, I unpack the shockingly modest policy riders that prompted Burr to pull his support, what’s likely to happen if Congress can’t get it’s sh*t together — and why I think, in the end, things will be just fine.

More here.

Another missed tobacco deadline for FDA

Last week we reported that the FDA was facing a major congressional deadline to decide which so-called synthetic nicotine products can stay on the market. And now they’ve officially missed it.

The FDA, it turns out, has ruled on zero synthetic nicotine applications so far. The agency hasn’t even decided how to deal with Puff Bar, the most popular vaping product with kids, which STAT confirmed as of Monday is still on shelves.

Instead, the FDA announced late last week that it was taking action against two companies – AZ Swagg Sauce LLC and Electric Smoke Vapor House – that did not submit an application to the FDA at all. It also announced that it was cracking down on more than 100 stores selling synthetic products to kids.

While both of those steps are notable from a public health perspective, it’s unclear why the FDA decided not to take action against more companies ahead of the congressional deadline. In a statement, the agency assured stakeholders it was going to be taking more action in the coming days. The FDA also said it’s processing applications for “approximately one million non-tobacco nicotine products submitted by more than 200 manufacturers.”

It’s time for hot lobbying goss

Health care companies will have to disclose on Thursday how much they spent on lobbying this spring. And while we won’t know till later this week how much PhRMA is spending as Congress pushes toward a drug pricing deal, or how much Juul is dedicating to advocacy as the FDA tries to push the company off the market, there are already some tidbits that caught our eye.

GenBioPro, the only generic drug maker in the U.S. approved to sell the abortion pill mifepristone has hired its first lobbyist ever, I reported on Friday.

An advocacy group created to lure Biden’s medical research agency, ARPA-H, to Massachusetts has hired three lobbyists at the firm Capitol Counsel, too.

And it seems that a number of companies that were pushing potential Covid-19 products on the Hill are hanging those efforts up. Inovio, the biotech company that failed to develop a Covid-19 vaccine, has dropped one lobbying firm they hired to advocate for that shot. (It’s still unclear, however, if the company plans to cease lobbying altogether.) So, too, did the High-Throughput Diagnostic Testing Coalition, a coalition of Covid-19 testing companies like Quidel that lobbied for “Medicare reimbursement incentives to encourage point-of-care diagnostic testing capacity.” UV-Concepts, a company that pushed for use of their UV light technology in airports, and Perspectum, a diagnostic company that wanted funding to study Covid-19, fired their lobbyists, as well.

I also couldn’t help but double take when I saw the company Biomeme had hired a lobbyist, too. (I was sad to learn the company does not create biotech memes – instead, they seem to be trying to get funding for their Covid-19 test.)

What we’re reading

  • Biotech executives pull in some of health care’s biggest paydays, with Regeneron’s CEO sitting atop the pack, STAT
  • Anthony Fauci wants to put Covid’s politicization behind him, Politico
  • UnitedHealth Group says Medicare Advantage saves money, but the data say otherwise, STAT
  • Kids’ coronavirus vaccines are hard to find in Florida. Many blame DeSantis, Washington Post
  • Dozens of lawmakers urge HHS to fine drugmakers for curtailing discounts to a federal program, STAT

Correction: An earlier version of this newsletter implied BIO executives would be in Washington this week. Their retreat begins next week. 





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