FDA Regulation
6 articles on FDA Regulation, written by Shotlee and medically reviewed for clinical accuracy.
FDA Considers Compounding Access for Unproven Peptides: What Patients Need to Know
The FDA is evaluating the regulation of specific peptides amid growing demand. We break down the science, the risks, and the clinical implications.
2 min read
RFK Jr. Misrepresents Ex-FDA Officials in Push to Lift Peptide Ban
Health Secretary RFK Jr. is pushing to lift the FDA's ban on 19 peptides used in compounding pharmacies, claiming the decision was illegal with no safety signals. But former FDA officials, including Janet Woodcock, say he misrepresents their views amid documented risks like immune reactions and trial fatalities. As demand surges via influencers, recent illnesses highlight the stakes in this regulatory battle.
6 min read
Hims & Hers Surges After RFK Jr. Pushes Peptide Access on Joe Rogan
Hims & Hers shares surged Monday after HHS Secretary Robert F. Kennedy Jr. expressed urgency on the Joe Rogan Experience to make 14 peptides more accessible. He highlighted FDA's review of the science behind these GLP-1 active ingredients for diabetes and weight loss. This could signal easing regulatory headwinds for telehealth providers like Hims.
5 min read
Knockoff GLP-1 Market Still the Wild West After Hims Fiasco
Telehealth giant Hims & Hers stirred controversy by launching a cheap compounded version of Novo Nordisk's Wegovy pill, only to yank it days later amid FDA crackdowns and lawsuits. This incident highlights the ongoing Wild West in the knockoff GLP-1 market, where unapproved compounded drugs flood the scene despite resolved shortages. Patients risk ineffective or unsafe products—here's what you need to know.
5 min read
Knockoff GLP-1 Market Still the Wild West: Hims Fallout
Telehealth firm Hims & Hers sparked chaos by launching a cheap compounded Wegovy pill, only to yank it days later amid FDA crackdowns and a Novo Nordisk lawsuit. This incident highlights the ongoing Wild West in the knockoff GLP-1 market. Despite resolved shortages for Wegovy and Zepbound, unregulated compounded drugs remain widely available.
5 min read
HIMS Shares Sink After FDA Vows Swift Action on Copycat GLP-1 Drugs
Hims & Hers Health's bold launch of a $49-per-month copycat GLP-1 pill to rival Wegovy's $149 price tag backfired spectacularly. FDA Commissioner Marty Makary vowed 'swift action' against such unapproved drugs, sending HIMS shares down 7.5% in premarket trading. This regulatory showdown highlights growing tensions in the GLP-1 market dominated by Novo Nordisk and Eli Lilly.
4 min read