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Regulatoryretatrutidefdaeli lillycongress

Lawmakers press FDA to close import loophole for knockoff retatrutide

The bipartisan group says the pathway is being used to bring in copies of Eli Lilly's investigational obesity drug, which has no approved form anywhere.

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By Daniel Okafor · Regulatory Correspondent
Oct 20 12:47 ETSource: STAT

The wire

  1. 01A bipartisan group of lawmakers has written to the FDA urging it to close a loophole used to import knockoff versions of retatrutide, Eli Lilly's investigational obesity drug.
  2. 02Retatrutide is unapproved, so any product reaching US patients comes from gray-market import or compounding channels that sellers and telehealth operators have leaned on.
  3. 03Whether the FDA acts, and through which authority, is unresolved; congressional letters carry no legal force on their own.

From the source

STAT+: A bipartisan group of lawmakers urges the FDA to close a peptide loophole

A bipartisan group of lawmakers is urging the FDA to plug a loophole used to import knockoff retatrutide, an investigational obesity drug made by Eli Lilly.

Read at statnews.com
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