RFK Jr Eases Access to Unproven Peptide10/29 06:08

   

   WASHINGTON (AP) -- The Trump administration on Wednesday acted to ease 
access to unproven peptide drugs favored by Health Secretary Robert F. Kennedy 
Jr. Food and Drug Administration scientific staffers had little input on the 
decision and opposed the changes, according to six people familiar with its 
development.

   The draft policy posted online by Kennedy's Department of Health and Human 
Services covers a handful of injectable peptides promoted within the wellness 
industry for uses such as building muscle, healing injuries and boosting 
energy. The government will take comments for two weeks before finalizing the 
measure.

   The document, primarily written by officials at HHS, faced overwhelming 
pushback among FDA drug staffers who warned it could undermine the agency's 
long-standing mission of keeping unsafe health products off the U.S. market, 
according to the people familiar with its development.

   The people spoke to The Associated Press on the condition of anonymity to 
discuss confidential government deliberations.

   The policy directs the FDA not to take action against specialty pharmacies 
that sell a half-dozen wellness peptides, including BPC-157, TB-500 and KPV. 
Under normal FDA rules, those chemicals would be considered illegal drugs 
because they have not gone through the agency's rigorous review process for 
safety and effectiveness.

   According to the document posted online, Kennedy determined the change 
"advances patient choice and freedom" while protecting people in the United 
States from peptides sold online that are often made from ingredients of 
unknown origin and quality.

   Kennedy has called himself a "big fan" of peptides and previously described 
using BPC-157 to treat a muscle injury.

   Lee Rosebush of the American Academy of Peptide Medicine said in an online 
post that HHS had taken "a huge step for patient and provider medical freedom." 
The group, which is not a medical professional society, represents people who 
prescribe or sell peptides.

   The peptide business has caught the attention of major telehealth providers, 
including Hims & Hers, which recently announced plans to offer wellness 
peptides once the government changed its policy. Wall Street analysts estimate 
the market could be worth more than $2 billion.

   Wellness peptides are not FDA approved 

   Some peptides occur naturally in the human body, where they trigger hormones 
needed for growth, metabolism and healing. Drug companies have brought several 
to market as medications, including mainstay treatments for diabetes and weight 
loss.

   The chemicals subject to the new policy have not been approved as safe and 
effective by the FDA. Still, they are promoted online by influencers and 
celebrities for a range of medical uses, including insomnia, anxiety, 
inflammatory conditions and migraines.

   Dr. Peter Lurie, a former FDA official, noted that the FDA has already 
approved rigorously tested drugs for all of those conditions.

   As people "are diverted from those drugs toward this stuff, there will be 
more unnecessary pain and suffering," said Lurie, who now leads the nonprofit 
Center for Science in the Public Interest.

   He also questioned the timing of the change, days before the midterm 
election.

   "This is a wink and nod to the MAHA faithful in the hope that they'll show 
up at the polls," said Lurie, referring to Kennedy's "Make America Healthy 
Again" movement.

   RFK Jr. and his MAHA followers support peptides 

   A spokesperson for HHS said the agency is "confronting the risks of 
black-market peptides" by giving Americans "a more controlled alternative 
through licensed U.S. compounders."

   It is the latest example of Kennedy reshaping U.S. health policy in the MAHA 
mold. Some of the biggest figures in that movement sell peptide injections and 
supplements.

   The decision is a stark break from past FDA efforts to limit the 
availability of unproven wellness products, including peptides, stem cell 
therapies and dietary supplements, that make unsupported medical claims. But 
that approach put the agency at odds with Kennedy, who has publicly endorsed 
the benefits of all of those products.

   The policy published Wednesday is a step back from HHS' original plan, 
according to two of the people who discussed its development.

   HHS officials initially wanted the FDA to draft an official regulation that 
would add BPC-157 and other peptides to a list of drug substances deemed safe 
for use by compounding pharmacies, specialty businesses that make customized 
medications.

   FDA officials warned that the agency's scientific staffers had major safety 
concerns and would not support a regulation deeming the peptides safe. HHS 
officials moved to a different approach that directs the FDA not to enforce its 
rules against pharmacies that compound the substances.

   FDA staffers ultimately provided technical assistance in drafting the HHS 
plan, including guardrails intended to improve safety, such as requiring 
pharmacies to use peptide ingredients from FDA-registered factories. 
Additionally, compounders are directed to collect information on side effects 
for safety analysis and verify the purity of peptides they use.

   Lurie pointed out that the FDA, under federal law, does not have the 
authority to enforce those pharmacy requirements.

   The Alliance for Pharmacy Compounding, which represents specialty 
pharmacies, said several details need to be clarified -- including when the 
policy takes effect and how it will intersect with state pharmacy boards, who 
traditionally regulate pharmacists.

   Decisions over compounding have long rested with the FDA, not HHS 

   Decisions about regulating peptides and compounding pharmacies have almost 
always come from the FDA, which has an office dedicated to protecting U.S. 
consumers from unsafe or poor-quality compounded drugs.

   The issue of compounding safety became a greater focus for the FDA after a 
deadly outbreak of fungal meningitis in 2012 was linked to contaminated 
injections from a Massachusetts compounding pharmacy. Once a niche business, 
compounding has grown into a multibillion-dollar industry, providing customized 
medications to doctors, clinics and hospitals.

   It's extremely rare for HHS to take the lead in drafting policies over the 
compounding industry, former FDA officials said. But federal law technically 
gives HHS authority over drug regulations, which are then delegated to the FDA.

   FDA has warned Americans about safety risks of unproven peptides 

   Many in the U.S. who are using peptides today do not deal with a doctor or a 
pharmacy to get the injections, but often order vials online sold by chemical 
manufacturers based in China. Peptide sellers often try to skirt U.S. 
regulations by labeling their products as "for research use only" because the 
FDA does not regulate research chemicals.

   In 2023, the FDA added more than a dozen peptides, including BPC-157 and 
TB-500, to its list of substances that should not be compounded due to risks of 
allergic reactions, kidney damage and tumor growth.

   At a meeting in July, FDA staffers reiterated that more than half a dozen 
peptides brought forward for reconsideration remained unproven in terms of 
safety and effectiveness.

   But a panel of outside experts voted to drop restrictions on the six 
peptides named in Wednesday's document. The panel -- selected by Kennedy's HHS 
-- included several doctors, pharmacists and consultants who work in the 
peptide field.