Trump admin eases access to unproven peptides favored by RFK Jr. despite FDA opposition
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admin → ease → opposition
The Trump administration on Wednesday acted to ease access to unproven peptide drugs favored by Health Secretary Robert F. Kennedy Jr.
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administration → act → drugs
Food and Drug Administration scientific staffers had little input on the decision and opposed the changes, according to six people familiar with its development.
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staffers → have → 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.
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policy → post → energy
The government will take comments for two weeks before finalizing the measure.
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government → take → 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 US market, according to the people familiar with its development.
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it → write → development
The people spoke to The Associated Press on the condition of anonymity to discuss confidential government deliberations.
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people → speak → 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.
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that → direct → BPC-157
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.
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they → consider → safety
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.
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that → accord → origin
Kennedy has called himself a “big fan” of peptides and previously described using BPC-157 to treat a muscle injury.
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Kennedy → call → 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.”
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HHS → say → freedom
The group, which is not a medical professional society, represents people who prescribe or sell peptides.
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who → represent → 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.
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government → catch → policy
Wall Street analysts estimate the market could be worth more than $2 billion.
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market → estimate → ?
Wellness peptides are not FDA approved
Some peptides occur naturally in the human body, where they trigger hormones needed for growth, metabolism and healing.
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they → approve → growth
Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss.
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companies → bring → diabetes
The chemicals subject to the new policy have not been approved as safe and effective by the FDA.
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chemicals → approve → FDA
Still, they are promoted online by influencers and celebrities for a range of medical uses, including insomnia, anxiety, inflammatory conditions and migraines.
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they → promote → insomnia
Dr. Peter Lurie, a former FDA official, noted that the FDA has already approved rigorously tested drugs for all of those conditions.
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FDA → note → 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.
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who → divert → Interest
He also questioned the timing of the change, days before the midterm election.
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He → question → election
A spokesperson for HHS said the agency is “confronting the risks of black-market peptides” by giving Americans “a more controlled alternative through licensed US compounders.”
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agency → say → compounders
It is the latest example of Kennedy reshaping US health policy in the MAHA mold.
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Kennedy → reshape → mold
Some of the biggest figures in that movement sell peptide injections and supplements.
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Some → sell → injections
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.
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that → limit → claims
But that approach put the agency at odds with Kennedy, who has publicly endorsed the benefits of all of those products.
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who → put → products
The policy published Wednesday is a step back from HHS’ original plan, according to two of the people who discussed its development.
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who → publish → 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.
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that → want → medications
FDA officials warned that the agency’s scientific staffers had major safety concerns and would not support a regulation deeming the peptides safe.
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peptides → warn → regulation
HHS officials moved to a different approach that directs the FDA not to enforce its rules against pharmacies that compound the substances.
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that → move → 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.
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staffers → provide → factories
Additionally, compounders are directed to collect information on side effects for safety analysis and verify the purity of peptides they use.
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they → direct → peptides
Lurie pointed out that the FDA, under federal law, does not have the authority to enforce those pharmacy requirements.
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FDA → point → 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.
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who → represent → 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 US consumers from unsafe or poor-quality compounded drugs.
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which → rest → 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.
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outbreak → become → pharmacy
Once a niche business, compounding has grown into a multibillion-dollar industry, providing customized medications to doctors, clinics and hospitals.
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compounding → grow → doctors
It’s extremely rare for HHS to take the lead in drafting policies over the compounding industry, former FDA officials said.
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officials → ’ → industry
But federal law technically gives HHS authority over drug regulations, which are then delegated to the FDA.
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which → give → FDA
…and 6 more, not listed.
The Aporia
