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It’s UFA week in Washington
Policy wonks are waiting with bated breath for the Senate HELP committee’s user fee reauthorization draft, which, as I scooped on Friday, will include reforms to the FDA’s regulation of dietary supplements, cosmetics, and lab-based tests. Staffers and lobbyists expected that draft to be released as soon as Monday, though the timeline has slipped a little. HELP is hoping to release the draft this morning, a senior committee staffer told STAT Monday evening.
On the House side, the full Energy & Commerce Committee will also hold their markup of the user fee bill on Wednesday. So far E&C — which loves to plug its bipartisan attitude but often gets bogged down in 12+ hour marathon markups thanks to partisan fights — has had virtually no fireworks during its debate over the bill. It passed its package out of the E&C health subcommittee last week 30-0.
Here’s are two fights you should be watching as the user fee package inches closer to President Biden’s desk:
Dietary supplements: We at STAT will be particularly interested to see how senators tackle this one, which is a priority of the Senate HELP Committee Chair Sen. Patty Murray. And there’s clearly a fight brewing: the five supplement groups in Washington all have very different — and very strong — feelings about the main bill being considered, which would require supplement makers to submit information, like the products they sell and their ingredients, to the FDA.
At the center of the spat are the Council for Responsible Nutrition, which represents industry giants like Nestlé and Bayer and supports the bill, and the vociferously opposed Natural Products Association, which represents both supplement makers and retailers. The latter has rallied nearly 5,000 letters to lawmakers arguing the bill would “allow bioterrorists to introduce contaminants into the food supply” because it would require supplement makers to publicly disclose sensitive details about their supply chains. (Adding to the fun: the two groups share several members.)
A last-minute accelerated approval blitz: Doctors for America, the liberal doctors group co-founded by Surgeon General Vivek Murthy, is in Washington this week pushing lawmakers to go even further in reforming the agency’s so-called accelerated approval pathway.
They want lawmakers to strike a part of the package that would let drug makers complete the follow up studies for accelerated approval drugs using so-called real-world evidence. They’re also calling for language in the bill that would automatically pull a drug’s accelerated approval when the company’s follow-on study doesn’t show a clinical benefit.
By the way, want more info about how the FDA’s accelerated approval pathway and all its other approval pathways work? STAT has a new in-depth report that’ll answer all your questions. Check it out here.
What happens when the federal government stops giving away Covid vaccines for free?
During the pandemic, the federal government took the highly unusual step of buying massive quantities of Covid-19 vaccines and therapeutics to give them away for free. But the handouts won’t last forever.
As Senate Republicans continue to slow-walk more funding for pandemic response efforts, a reality where vaccines and treatments are bought and sold like other medicines is more and more likely. Executives at both Moderna and Pfizer have faced questions from investors in recent weeks about what their strategies are.
A transition would be logistically fraught, and could present the same challenges that plague every other disease area — particularly the possibility of price hikes, and inequitable access to lifesaving medicines. My colleague Rachel Cohrs breaks down the biggest questions as the health care system plans for what’s next.
Schrader’s moment of truth
Rep. Kurt Schrader (D-Ore.), one of the key players who helped water down Democrats’ drug pricing ambitions in last fall’s intense negotiations, today faces an “existential primary threat” from progressive challenger Jamie McLeod-Skinner, in the words of prominent elections analyst Amy Walter.
A drugmaker-backed dark money group aligned with moderate Democrats called Center Forward has spent more than $1 million to protect Schrader, according to OpenSecrets. The brand-drug lobby PhRMA gave Center Forward $1.6 million in tax year 2019.
In one of his recent ads, Schrader touted his drug pricing credentials, citing the introduction of his comparatively modest drug pricing proposal as “taking on drug companies,” and claimed he is “leading the fight to get big money out of politics.” Schrader also has a rare endorsement from President Biden.
Did the public health emergency see its shadow?
The federal public health emergency — and all the regulatory flexibilities that come with it — doesn’t technically end until July 15. But the Biden administration has adamantly insisted that officials will give at least 60 days’ notice before ending it, which would have had to come Monday. Given that there was no word of a termination, it seems likely the administration will extend the designation at least through October, my colleague Rachel Cohrs points out.
That means that one of the most disruptive changes — a process that could kick millions of people off of Medicaid rolls nationwide — will likely kick into gear after the midterm elections in November.
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The NIH has agreed to license Covid-19 vaccine technologies to the developing world.
Digital health companies are bracing for the FDA to get tougher toward industry.