STAT: A no good, very bad week for the FDA

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Dietary supplements, really, really aren’t regulated, huh?
The law governing the FDA’s oversight of dietary supplements is remarkably weak — the agency doesn’t approve supplements like traditional medicines, and it can’t even really police the claims that pepper the bottles of these products. But the law does include one provision meant to keep consumers safe: Any time a supplement maker introduces a totally new ingredient into the market, they are supposed to tell the FDA about it and provide the agency with some information on why they think it’s safe.
There’s just one problem: Dietary supplement makers aren’t actually submitting the info. The FDA believes that it should have received notices about roughly 4,600 new ingredients, but it has only received roughly 1,200.
Pieter Cohen, a prominent watchdog of the supplement industry, told STAT the whole saga demonstrates “the collapse of the [limited] safety system that was put in place to protect consumers from dangerous new ingredients.”
The FDA thinks it has a strategy to get the industry to start complying with the law — but supplement makers still aren’t convinced.
Read my deep dive on the dysfunction here.
Drug pricing nerds: You’re going to want to see this
The drug pricing sleuths at 46Brooklyn may have stumbled upon the motherload: A database of drug prices in the highly controversial drug discount program known as 340B. Technically, 340B prices are considered confidential, but 46Brooklyn stumbled upon a dataset published by the Texas Department of Health and Human Services that estimates the 340B price pursuant to a wonky agreement with federal regulators. They’ve built a tool to analyze that data here.
The data is complex – but we’ll be on the lookout for trends and other surprises. Just the decision to publish it is also a little controversial, 46Brooklyn’s CEO Antonio Ciaccia told STAT.
“This type of data being publicly available will piss off a lot of people,” Ciaccia said. “I like the chaos that this creates.”
Note: After this email newsletter went out, STAT spoke with experts who questioned the validity of some of the Texas data. We’ll have more on that in next week’s edition.
A no good, very bad week for the FDA
Let’s be honest: It’s been a rough week for the FDA and Commissioner Robert Califf, especially on Capitol Hill. He’s been taken to task by lawmakers both in person and in correspondence. Here’s our rundown of the biggest 👀 moments.
On the infant formula shortage: A formula shortage is a bad headline for any administration, but the situation got particularly worse for the FDA on Thursday when the chair of the House Appropriations committee, Democratic Rep. Rosa DeLauro, told Califf, heatedly, that the shortage “was caused in large part by the lack of action by the FDA.” DeLauro was mad the FDA did not quickly investigate an earlier whistleblower complaint about problems at a major formula manufacturing facility. (Califf declined to tell lawmakers why the FDA did not investigate the complaint earlier, but generally pushed for greater resources for the FDA’s food program.) Califf will testify on the issue again in the House Wednesday and in the Senate Thursday.
On e-cigarettes: When the FDA disclosed last week that it wouldn’t be finished reviewing applications from e-cigarette companies until June 2023 — despite a federal judge directing the FDA to finish this work by last September, Califf got a strongly worded letter from several Democratic senators, who said the delay “threatens public health.” (An FDA spokesman said it “remains committed to providing continued regular updates to the public about our premarket review.”)
On pediatric vaccines: The FDA announced Monday it will hold its advisory committee meeting for Pfizer’s pediatric vaccine the same day it reviews Moderna’s pediatric application. It’s good news for parents, but it’s likely to fuel suspicion — and anger — that the FDA waited until Pfizer’s application was ready to approve Moderna’s application, which was filed last month. “If the administration really does evaluate both vaccines at the same time (ie appears to have delayed Moderna till Pfizer could “catch up”), hell’s gonna break loose,” former Surgeon General Jerome Adams tweeted Monday in response. (The FDA spokesperson noted that holding the panels together will “allow the most optimal decision-making by FDA experts because they will have the comprehensive analyses for both vaccines in the youngest patient populations before them.”)
Learn more about monkeypox, the world’s next infectious disease threat
When STAT’s Pulitzer finalist infectious disease reporter Helen Branswell zeroes in on a new infectious disease threat, it’s best to pay attention.
A monkeypox outbreak is causing growing concern among the global health community because seemingly unrelated cases are popping up in Europe, Canada, Australia, and the United States — places where infections don’t usually occur. That means it’s possible that there’s been undetected spread, and the disease has a long incubation period that can range from five days to three weeks, according to the World Health Organization.
And now, even though they have had trouble convincing Congress to scrounge up $10 billion for ongoing Covid-19 response efforts, senior Biden administration officials are asking for more biodefense funding. In a call with reporters Friday, they made a pitch for lawmakers to fulfill an $88.2 billion budget request to invest in pandemic preparedness and infectious disease threats like monkeypox, my colleague Rachel Cohrs reports.
Here’s more of STAT’s must-read dispatches on monkeypox:
What is monkeypox and how does it spread?
A CDC official answers questions about how monkeypox spreads and what symptoms look like
The first confirmed monkeypox case in the United States surfaced in Massachusetts
A primer on why health officials are concerned about the outbreak, including background about available vaccines
What we’re reading
How a complex web of businesses turned private health records from GE into a lucrative portrait of patients, STAT
The C.D.C.’s pandemic team will surrender some responsibilities, New York Times
Pfizer to refund $290,000 to consumers in four states over misleading copay coupons, STAT
An Obamacare fiasco could blow up on Democrats right before the midterms, Politico
The Buffalo shooting is igniting a debate over the role of genetics researchers in white supremacist ideology, STAT