DOWN -8% AT SOME POINT OF THE DAY
The letter is dated Sep 9.
$HIMS must respond by Sep 30 (within 15 working days).
$HIMS (-8.47%) IS NOT THE ONLY COMPANY THAT RECEIVED WARNING LETTERS FROM THE FDA
$LLY (-3.36%) AND $NOVO B (-3.44%) ALSO RECEIVED LETTERS FOR FALSE & MISLEADING CLAIMS AND MISBRANDED PRODUCTS
$LLY (-3.36%) received three letters -- about Zepbound and Mounjaro.
And $NOVO B (-3.44%) received one letter -- about Wegovy, Ozempic, and Victoza.
The letters target an Oprah primetime special and local TV sponsored segments for omitting key information about $LLY (-3.36%) and $NVO (-3.35%) 's GLP-1s.
The FDA flagged company reps and paid consultants for downplaying pancreatitis and gallbladder risks as "overhyped" and calling thyroid-cancer concerns "very, very rare."
The FDA also flagged the omission of other serious warnings like hypoglycemia, kidney injury, diabetic retinopathy, and suicidal behavior and ideation.
Suffice it to say $HIMS (-8.47%) is not the only company pushing the limits and getting slapped on the wrist. $NVO (-3.35%) and $LLY (-3.36%) have been called out by the FDA as well.