How thyroid drugs became a MAHA flashpoint

Politico

a day ago

Driving the Day
THYROID DRUG PUSHBACK — A recent FDA letter to makers and distributors of a decades-old thyroid medication has stoked outrage among a subset of pharmacists and wellness influencers linked to the Make America Healthy Again movement led by Health Secretary Robert F. Kennedy Jr.
The products in question are known as desiccated thyroid extracts, which are 'the dried, ground-up thyroid glands of pigs,' according to Tenille Davis, the Alliance for Pharmacy Compounding's chief advocacy officer. The animal-derived drugs, which predate the FDA as an institution, are among the treatment options for people with an underactive thyroid, or hypothyroidism, though the agency says most patients take FDA-approved synthetic hormone replacements.
But last week, the FDA informed firms that market animal-derived versions that it would take action if they continued to sell them. The agency said it received more than 500 adverse event reports from the products between 1968 and February 2025 — with a substantial increase seen between 2019 and 2020.
'FDA is committed to pursuing the first-ever approval of desiccated thyroid extract, pending results of the ongoing clinical trials. In the mean time, we will ensure access for all Americans,' FDA Commissioner Marty Makary posted on social media platform X on Thursday.
The agency said it would give 'adequate time' for providers to transition patients to FDA-approved options, noting it expects them to need about 12 months.
The uproar: Some wellness influencers with ties to Kennedy panned the FDA's move on social media and urged their followers to sign online petitions urging the agency to back down.
Brigham Buhler, who owns the compounding pharmacy ReviveRX and is aligned with many of Kennedy's policy priorities, suggested the agency's position favors AbbVie, which makes synthetic thyroid medicines and has another candidate in clinical trials.
'Is this an example of fda working for Pharma again to create another monopoly over a drug that has been used for 100 plus years so that they can raise the prices like Pharma bro Martin [Shkreli] again?' he said in a text message.
AbbVie said it would work with the agency to ensure access is not interrupted. The FDA did not respond to an interview request.
'With our ongoing clinical trials, we remain committed to these patients and their providers,' AbbVie posted Thursday on X.
Why it matters: The drugs are used to prevent side effects of hypothyroidism, such as fatigue and weight gain. A doctor must closely monitor dosing because the margin between a low dose that might not be effective and a high dose that could cause side effects is small.
Davis said some patients don't respond well to the synthetic drugs. While their blood panels might suggest the medication works, she said, patients continue to 'feel really crappy' until they switch to the animal-derived versions.
Those people might be in the minority, Davis said, but they're still a sizeable population given the number of Americans with hypothyroidism. 'It's happened enough times where these patients aren't crazy,' she said.
IT'S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. The FDA cautioned against sunscreens that come in mousse form this week, saying they might not be effective.
Send tips to David Lim ([e-mail], @davidalim or davidalim.49 on Signal) and Lauren Gardner ([e-mail], @Gardner_LM or gardnerlm.01 on Signal).
AROUND THE AGENCIES
VAX SAFETY GROUP IS BACK — HHS said Thursday it's bringing back a 1990s-era task force on safer childhood vaccines, fulfilling a demand made by the secretary's old colleagues at an anti-vaccine group, Lauren reports.
The department is reinstating the group, which was created by the 1986 law establishing a compensation program for vaccine-injured people, 'to improve the safety, quality, and oversight of vaccines administered to American children,' HHS said in a statement.
NIH Director Jay Bhattacharya will lead the effort, with leaders from the FDA and the CDC participating. An HHS spokesperson didn't specify who else from the agencies would sit on the panel.
HHS Secretary Robert F. Kennedy Jr. has long questioned the safety of the modern childhood vaccination schedule, suggesting the number of shots young kids receive may contribute to myriad chronic conditions, including autism. Dozens of scientific studies have found no link between vaccines and autism.
Background: The Task Force on Safer Childhood Vaccines' earlier iteration disbanded in 1998 after issuing recommendations for ways the government could support the development of safer vaccines, improve adverse event surveillance and educate the public about their benefits and risks.
But the law that established the task force also directed HHS to report to Congress every two years about actions it had taken to promote safer products — a paperwork burden that the Kennedy-founded group Children's Health Defense says was never met.
HHS's announcement came the day before the federal government is due to respond to CHD's May lawsuit regarding Kennedy's failure to reestablish the task force. In a deadline extension request filed last month and approved, Justice Department lawyers indicated the parties could reach a settlement.
'It took nearly 30 years for HHS to do this, but at last, we have an HHS secretary who is following the law on this vital issue,' CHD President and CEO Mary Holland said in a statement.
What's next: The task force is supposed to collaborate with the Advisory Commission on Childhood Vaccines, a lesser-known federal advisory committee in the vaccine space, in developing its recommendations.
The secretary can appoint up to nine ACCV voting members, evenly split among health professionals, attorneys and the general public — at least two of whom have children who were injured by a vaccine. Of the current roster, no member's term ends before July 2026, and it's unclear whether Kennedy might try to shake it up before then as he did with the CDC's independent vaccine panel.
Drug Pricing
LILLY'S MFN PLAY? Indianapolis-based Eli Lilly said Thursday it would raise prices on its drugs in European markets as a way to lower costs for American consumers — an apparent response to President Donald Trump's most-favored-nation pressure campaign, Lauren writes.
The statement came two weeks after Trump sent letters to the leaders of major drug manufacturers — and posted them on social media — demanding they embrace most-favored-nation pricing that ties U.S. prices to lower figures paid in other wealthy nations or face unknown consequences.
'Lilly supports the administration's goal of keeping the United States the world's leading destination for biopharmaceutical research and manufacturing, and the objective of more fairly sharing the costs of breakthrough medical research across developed countries,' the company said in a statement.
When asked to elaborate on how the drugmaker will achieve that goal — and which drugs may be implicated — a company spokesperson referred to the online statement.
Eye on the FDA
GOLD STANDARD SCIENCE? The FDA quietly posted a new staff manual laying out the 'core tenets of gold standard science' online this week, following up on an executive order from President Donald Trump in May.
'In conducting our mission to protect and promote public health, FDA must generate and evaluate science in a manner that ensures FDA will make sound, objective decisions,' the staff manual states. 'Preserving and promoting GSS is essential to ensuring that FDA's mission succeeds and our regulatory decisions advance public health.'
The document says the FDA will focus on reproducibility and replicable science, transparency in its research process, communication of errors and uncertainty and encouragement of collaborative and interdisciplinary approaches in science.
It also says the FDA will embrace 'a culture of constructive skepticism in science through policies and programs that emphasize critical evaluation, transparency and objectivity,' values science that includes testable hypotheses with 'explicitly defined measurable criteria for falsification,' and recognizes the value of studies that have negative results.
Document Drawer
FDA Commissioner Marty Makary met with Sen. Steve Daines (R-Mont.) on July 30 to discuss abortion pill mifepristone, according to newly posted public calendar disclosures. He also held an introductory meeting with Sen. Amy Klobuchar (D-Minn.) on July 31.
The FDA will hold a public meeting on Sept. 19 to discuss how to advance the development of interchangeable biosimilar products.
The Health Resources and Services Administration is asking for feedback on its recommendation to add Duchenne muscular dystrophy and metachromatic leukodystrophy to the Recommended Uniform Screening Panel — a step that would require most insurers to cover the screenings without cost-sharing.
WHAT WE'RE READING
Costco will not dispense abortion pill mifepristone at its pharmacies, Bloomberg's Jeff Green and Jessica Nix report.
President Donald Trump signed an executive order Wednesday directing HHS to stock drug ingredients to help bolster domestic supply, Lauren reports.