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(R-KS) sent a bipartisan letter to the FDA flagging Hims & Hers' ad and accusing the company of misleading patients "by omitting any safety or side effect information when promoting a specific type of weight loss medication." Under federal law and regulations, FDA requires that prescription drug advertisements be truthful, not misleading, and balanced—failure to do so risks FDA enforcement action, including civil monetary penalties, Durbin and Marshall said in the letter
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The appeal should include: A letter from the provider explaining why the medication is medically necessary Any additional documentation not included in the original prior authorization References to clinical guidelines supporting the use of the medication in this patient CDPHP's appeal address and fax number are listed on the denial letter
