@YaleMed Assistant Prof, @Yale_CRRIT Co-Director, @Drsforamerica Board of Directors #patientsbeforeprofits *Views here are my own*
New Haven, CT, United States
Joined April 2010
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While this paper focuses on FAERS (FDA's passive drug safety surveillance system), the limitations also apply to VAERS for vaccines. Current FDA leadership is using VAERS to make conclusions despite its many limitations & with no transparency of how the reports were investigated.
Now out in @NEJM is a new Perspective piece from the CRRIT team on the potential consequences of @US_FDA’s recent announcement to release daily drug adverse event reports from FDA’s Adverse Event Reporting System (FAERS) nejm.org/doi/full/10.1056/NE… (1/10)
The winners of yesterday's HHS ill-advised policy to seemingly legitimize unproven peptides with no clinical evidence of safety, efficacy, & quality aren't patients but telehealth platforms & compounders (for Hims, they're one & the same), now gifted a peptide-laden cash cow.
Today you can get a first look at Peptides+, our new specialty built around a clinically guided protocol and ongoing clinical support. We’ve been building for this. Join the list to be among the first in line when we launch: hims.com/peptides-plus
Important disclaimers here: news.hims.com/disclaimers/ca…
Also, the "safety measures" included in this policy will do very little to protect patients. Lats week, I explained why: nitter.cf/reshmagar/status/21134…
As @CSPI's Peter Lurie said: "They’re trying to create the appearance of guardrails where none exist." (h/t @MargaretManto)
A plan to give people in the U.S. easier access to unproven peptide drugs favored by Health Secretary Robert F. Kennedy Jr. was opposed by most FDA scientific staff members, who had limited input in drafting the policy, according to six people familiar with its development. to.pbs.org/4BBDu6M
Many thanks to @AP_FDAwriter for making clear that HHS (RFK Jr.) unprecedently went over FDA's technical experts to push this policy forward despite their repeated concerns about the lack of evidence for peptides' safety, efficacy, & quality in patients.
A plan to give people in the U.S. easier access to unproven peptide drugs favored by Health Secretary Robert F. Kennedy Jr. was opposed by most FDA scientific staff members, who had limited input in drafting the policy, according to six people familiar with its development. to.pbs.org/4BBDu6M
Reshma Ramachandran retweeted
New: A top U.S. official endorsed a key policy change on hormone replacement therapies while holding at least $115,000 in stock in a company that provides access to menopause treatments. Ethics experts called it an “obvious conflict of interest.” propub.li/4suYw2B
Hims & Hers acquired its own peptide manufacturing facility in 2025 & is now celebrating this policy allowing unproven peptides as its latest cash grab. As we found in our secret shopper study, there'll be little to no prescriber oversight to protect patients & prevent harms.
$HIMS
🚨 HHS INTERIM ENFORCEMENT PEPTIDE POLICY
"The Secretary of HHS [RFK Jr.] has determined that this limited enforcement-discretion policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients. By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative."
"Based on the available evidence, including the recommendations of a recent Pharmacy Compounding Advisory Committee, the Secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety."
"Until a peptide bulk drug substance is addressed in a final rule as being included or not included on the 503A bulks list, HHS does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance that is not a component of an FDA-approved drug product, the subject of an applicable USP or NF monograph, or on the 503A bulks list codified at 21 CFR 216.23(a), when all of the following circumstances are present:"
1. 503A Interim Access List: BPC-157, TB-500, MOTS-c, KPV, Semax, or Epitalon
2. Peptide Identity: The peptide must meet the identity specifications and administration-route limitations in Appendix B
3. Characterization & Testing: The substance must come from an FDA-registered facility and have a valid Certificate of Analysis (COA) confirming identity, purity, potency, and contaminant testing
4. Manufacturer Requirements: The original manufacturer must be FDA-registered, comply with CGMP requirements, and be identified on the COA. Intermediaries must validate suppliers
5. Reporting Requirements: Compounders must report products compounded, serious adverse events, and product quality issues to FDA and relevant states. Reporting instructions must appear on product labeling
6. Product Labeling: Labels must state: “This is a compounded drug product. Not for resale.”
7. Single Active Ingredient: Each compounded product may contain only one peptide API from Appendix A. No peptide combinations.
8. Oral Bioavailability: Oral formulations require documentation demonstrating adequate human bioavailability.
9. Drug Delivery Devices: Only FDA 510(k)-cleared syringes may be packaged with or contain the compounded drug.
10. Compliance With Existing Law: Products must satisfy other applicable FD&C Act requirements, including sanitary compounding conditions and valid patient-specific prescriptions.
How can patients give informed consent for a treatment if the telehealth platform & clinician is financially incentivized to prescribe these products of unknown quality, safety, & efficacy? When has a "trust me, bro" policy ever worked for the public jamanetwork.com/journals/jam…
Reshma Ramachandran retweeted
“This is a wink and nod to the MAHA faithful in the hope that they'll show up at the polls,” said Dr. Peter Lurie, a former FDA official who now leads @CSPI.
apnews.com/article/peptides-…
SCOOP: A Trump administration plan to give Americans easier access to unproven peptides was opposed by FDA drug staffers, who had limited input in drafting the policy.
apnews.com/article/peptides-…
Just bonkers after FDA's own scientists concluded that there is no demonstrable evidence of safety, efficacy, or even quality for peptides considered in July for legal compounding. Instead of demanding evidence, HHS essentially says "good luck" to patients in figuring this out.
Reshma Ramachandran retweeted
Last week, @realtahiramin, @reshmagar, and @cmorten2 sat down to discuss pharmaceutical monopolies and what it will take to end the drug pricing crisis. Thank you to everyone who came out, and to @nyulaw for hosting!
in their recommendation to not allow for legal compounding of these peptides (in addition to pointing to decades of evidence showing no demonstrated efficacy or safety nor there being established quality standards for these products): healthaffairs.org/content/fo…
For an administration that is so concerned about fraud, waste, and abuse, opening the doors to unproven peptides only creates more of these problems for patients. Plus stripping health insurance from millions means they won't be able to see a doctor who can provide independent...
Requiring compounders to report adverse events for peptides where there is no evidence of efficacy, safety, and quality is basically putting a bandaid on a bullet hole. Here are the many reasons why this is an awful idea that will fail to protect patients:
New: Top officials at HHS and FDA have been working to balance Health Secretary Robert F. Kennedy Jr.’s push to expand access to buzzy peptides with safety concerns raised by agency scientists. A peek behind the curtain with new details on the path ahead w/ the dream team @rileyraygriffin @g0ingmad @nyahphengsitthy
🎁: bloomberg.com/news/articles/…
overstating benefits or not disclosing/underplaying risks to attract patients and then having little to no clinical oversight of the prescription process, providing care that is centered around a prescription and not the patient: jamanetwork.com/journals/jam…
as we've found, despite arguments from the peptide industry that patients will be safe with clinician providing oversight, that is not what happens in practice. These platforms effectively act as a pill mill using misleading marketing including... jamanetwork.com/journals/jam…
FDA deal with this patchwork of state policies to ensure compliance and enforcement? 5. Telehealth platforms like Hims&Hers and others are waiting for FDA/RFK to turn on the switch for peptides to start widely marketing and prescribing to patients but... fiercehealthcare.com/health-…
4. Under current law, these pharmacies are also not required to be registered with the FDA so the agency will have to rely on state regulators to find these pharmacies and ensure ongoing reporting. But state regulations are highly variable including around inspections! How will..
3. Under this administration, FDA has lost almost a quarter of its technical capacity through DOGE and others leaving the agency. So who is left to take on this monumental task of monitoring these pharmacies selling unprovem peptides? statnews.com/2026/09/17/fda-…
this primary relies on insurance claims data and electronic health records. These studies of reported adverse events are necessary for FDA to take timely regulatory action like shutting down a compounding pharmacy that is selling harmful products. jamanetwork.com/journals/jam…
system to investigate these signals which leads me to point 2. As these peptides will be available outside of insurance and traditional healthcare (ie, telehealth, medspas), FDA will not be able to use its active surveillance system, Sentinel to investigate these signals as...