Healthcare
|
Health Care
|
|
|
|
FDA panel rejects only 1 peptide despite backlash |
A Food and Drug Administration committee has accepted all but one of seven peptides to the list of substances compounding pharmacies can make.
|
© AP Photo/Jacquelyn Martin
|
The FDA's Pharmacy Compounding Advisory Committee (PCAC) on Thursday voted in favor of adding the peptides BPC-157, KPV, TB-500 and MOTS-c to the 503A Bulks list of substances permitted to be made and sold by compounding pharmacies.
These votes went in the face of FDA scientists who strongly advised that there was not enough strong evidence demonstrating the safety and efficacy of any of the peptides being considered by the committee.
Several members appointed by Health and Human Services Secretary Robert F. Kennedy Jr., who's called himself a "big fan" of peptides, own clinics or businesses that sell peptides.
The votes on Thursday were nearly evenly split, with one side arguing not enough evidence had been presented to support adding these substances to the list while supporters of the peptides argued there wasn't enough evidence to disprove the benefits either.
PCAC members returned on Friday to consider emideltide, semax and epitalon for addition to the compounding list. The panel ended up only voting against adding emideltide to the list, the first peptide to be rejected. Six members voted "yes," seven voted "no" and one member abstained.
Emideltide, a synthetic peptide, is purported to have potential use for treating opioid withdrawal, chronic insomnia and narcolepsy.
FDA staffers noted a common issue across all these peptides was that there was no standardization within the market, leading many products to carry the same name while having different molecular structures. They further characterized past studies on the peptide as being poorly constructed with small sample sizes and poor selection of control groups.
PCAC member Kevin Zacharoff explained his "no" vote saying, "It's impossible for me to not take the FDA's recommendations at heart with respect to safety and efficacy."
|
Welcome to The Hill’s Healthcare newsletter, we’re Nathaniel Weixel and Joseph Choi — every week we follow the latest moves on how Washington impacts your health.
|
|
|
|
The Hill Insider is coming
|
A new all-access digital subscription from The Hill — launching July 2026. Join the waitlist to be among the first inside
|
|
|
|
How policy will be impacting the healthcare sector this week and beyond:
|
|
|
|
Federal health officials have linked cyclospora outbreaks in four additional states to the same iceberg lettuce sourced from central Mexico that has sickened thousands of people in the Midwest. The new states are Illinois, Kansas, Oklahoma and Pennsylvania. They join Michigan, Ohio, Indiana, Kentucky and West Virginia as part of the country’s largest known cyclosporiasis outbreak, according to an update posted Friday. The …
|
|
|
|
|
The Centers for Disease Control and Prevention’s (CDC) tally of 2026 measles cases has officially surpassed the annual total of last year, with more then 2,300 cases reported from across most of the country. As of July 23, the CDC has confirmed 2,318 new measles cases in 2026, compared with 2,289 total cases detected in 2025. Johns Hopkins University’s measles tracker had noted the milestone earlier this week, being …
|
|
|
|
|
(NewsNation) — A 65-year-old retiring this year can expect to spend $185,500 on healthcare and medical expenses throughout their golden years. That’s up 7.5 percent from Fidelity Investments’ estimate of $172,500 a year ago and more than double its inaugural estimate from 2002. This year’s increase is nearly twice as large as the jump from 2024 to 2025 and reflects rising prices for care, increased utilization …
|
|
|
|
|
When America leads in medicine development,
every American benefits.
|
Americans get new medicines 3 years faster than other high-income countries thanks to our biopharmaceutical leadership. If Washington copies other countries' price control policies, we risk America’s access to cures. Learn more
|
|
|
Branch out with a different read from The Hill:
|
Heavy smoke from wildfires blankets the US Midwest and Northeast, prompting evacuations
|
Thousands of visitors were told to evacuate a remote Minnesota wilderness area accessible only by boat as wildfires send dangerously heavy smoke over the U.S. Midwest and Northeast this week. More than 100 wildfires are burning in Canada, where a train crew in northern Ontario filmed themselves surrounded by flames before being safely …
|
|
|
|
Local and state headlines on healthcare:
|
- Pregnant woman’s roadside death triggers push to reopen Mississippi delta hospital (KFF Health News/Mississippi Today)
- ACLU sues Pennsylvania State Health over canceled gender-affirming care procedure (Pennsylvania Capital-Star)
- Federal judge appoints receiver to take over Arizona prison healthcare after years of constitutional violations (ABC15 Arizona)
|
|
|
|
Health news we’ve flagged from other outlets:
|
- White House offers its science blueprint: More AI, less life sciences (Stat)
- The CDC's website still cites a retracted study linking vaccines and autism (NOTUS)
- Merck licenses experimental HIV pill to generic makers in 129 countries (Reuters)
|
|
|
|
Opinions related to health submitted to The Hill:
|
|
|
|
|
You’re all caught up. See you Monday!
|
400 N Capitol Street NW Suite 650, Washington, DC 20001
|
Copyright © 1998 - 2026 Nexstar Media Inc. | All Rights Reserved.
|
|
|
|
|
If you believe this has been sent to you in error, please safely unsubscribe.
No comments:
Post a Comment