Docket Alarm data shows over 3,000 suits against Novo and 1,900 against Lilly, with many GLP-1 stomach injury claims now in a Pennsylvania MDL.
Recap by typeshit. Full story at Law Street Media.
Per @pamelajeannoble, the letter flags contamination risks, manufacturing conditions and compounded copies resembling approved drugs.
Gounder notes the policy requires no testing of finished vials or deadline for side effect reports, and public comments on the draft run through November 13.
Healio
Durrani tells Healio the move bypassed rulemaking and FDA scientists, and warns patients may wrongly read it as FDA approval while long-term data is missing.
AP sources say FDA scientists opposed the HHS draft telling the agency not to act against pharmacies compounding six wellness peptides. Comments are open for two weeks.
Hims & Hers and a peptide academy met White House reviewers before release, and the Partnership for Safe Medicines has petitioned the FDA to block it.
On his podcast, Khan cites studies suggesting hunger hormones rebound within four weeks and about 60% of lost weight comes back within a year.
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