FDA panel endorses peptides despite safety concerns from agency scientists

An FDA advisory panel last week recommended the broader use of six out of seven peptides it reviewed, despite agency scientists voicing safety concerns for all of them.

Peptides are short chains of amino acids that play a role in regulating hormones, releasing neurotransmitters, and repairing tissue. Synthetic peptides have gained popularity among wellness influencers and biohackers, who often take them via injection, hoping to enhance their athletic performance and optimize their health.

Currently, peptides are not FDA approved, but they have received vocal support from HHS Secretary Robert F. Kennedy Jr., who has said he wants to loosen restrictions on the production of some peptides.

FDA has banned U.S. compounding pharmacies from producing peptides, but personal use is legal. So-called "gray market" peptides are often sold online and labeled "for research purposes only" as a legal loophole.

Last week, FDA's Pharmacy Compounding Advisory Committee (PCAC) voted to add six peptides to the list of substances that specialized pharmacies, called compounding pharmacies, can make for patients. However, the committee voted down the broader use of the rarely used peptide emideltide, which had been proposed for opioid withdrawal, chronic insomnia, and narcolepsy.

During PCAC's meetings, some FDA scientists noted that the peptides under review hadn't been proven to be safe or effective and could present a risk to patients, adding that any hazards that emerge could be difficult to track since the advised action would push peptide use into a lightly regulated market that's largely overseen by state pharmacy boards.

John Hertig, a pharmacist and a board chair of the Collaborative for Evidence-Based Medicines, said he's concerned the additions will amount to an end-run around of FDA's approval process, saying it creates "another parallel pathway to get this product in front of the public at much less rigor, fewer science-backed studies, and really does put the entire public and patient safety system at risk."

(Semuels, TIME, 7/24; Lou, MedPage Today, 7/24; Jewett/Smith, New York Times, 7/27)

CMS says Medicare Part D subsidies will expire at the end of the year

CMS on Tuesday announced that a subsidy program aimed at holding down premiums for Medicare Part D plans will expire at the end of the year, arguing the program is no longer necessary.

Part D plans offer standalone drug coverage alongside the traditional medical benefits of Medicare. Premiums for these plans have been rising in part because of the growing expenses for GLP-1 medications and other specialty drugs, as well as changes implemented under the Inflation Reduction Act (IRA). Although the IRA reduced many out-of-pocket expenses for Medicare enrollees, it also required  insurers to carry more costs.

The subsidy program, which has paid out an estimated $9.8 billion, according to a Government Accountability Office report, was aimed at blunting increases in Part D premiums. According to a Trump administration official who spoke to the Wall Street Journal, the subsidies encouraged insurers to raise rates, knowing that the federal government would pick up the extra cost. The official said the subsidies are no longer needed and that other policies that help reduce Part D costs also remain in place.

"We are stabilizing the market so this bailout is no longer needed," said CMS Administrator Mehmet Oz in a social media post.

According to KFF, the average premium for a Part D plan was around $36 a month this year. The administration official who spoke to the Journal said around 25% of Part D plan enrollees would see premiums for their plans either stay flat or go down next year, while around 30% would see an increase of less than $10 to their monthly bill. The remaining 45% will see an increase of between $11 to $20 a month, the official said.

(Robbins/Abelson, New York Times, 7/28; Mathews, Wall Street Journal, 7/28)

In an email obtained by KFF Health News, a CPSC official insisted that hospitals provide all ED patients' identifiable information, including names, addresses, diagnoses, and other personal details, to the contractor Konza Health for analysis. Representatives from Konza described participation in emails with hospital executives as "mandatory" or "required."

While federal public health authorities can't legally mandate that private health data be reported, CPSC officials have suggested that if hospitals decline to share data with the NEISS, they could be subject to strict penalties from a data-sharing regulation known as "information blocking."

(Seitz, et al., KFF Health News, 7/27; Hooper, POLITICO Pro, 7/21)

Trump plans 100% tariffs for generic drugs in 2028

President Donald Trump last week said that generic drugs imported into the United States will face no tariffs for two years starting on Aug. 1 before a 100% tariff goes into effect in August 2028 before rising to 200% a year later.

This phased schedule is intended to push generic drugmakers to move their production to the United States, Trump said in a social media post. In the post, he described the tariff escalation as "a penalty" for companies that don't build their plants and facilities in the United States during the grace period.

Virtually all prescriptions in the United States are filled with generic drugs that often come from overseas manufacturing and involve complicated ownership structures.

According to Deborah Elms, head of trade policy at the Hinrich Foundation, Trump's latest move underscores his goal to reshore low-cost drug production to the United States. However, building pharmaceutical production in the United States is expensive and complicated and virtually all of the inputs would still come from abroad.

"I am not sure that even a potential 200% tariff will change the fundamental math," Elms said.

(Bao, CNBC, 7/22)