FDA Warnings Issued Over Drug Company Marketing

The Food Drug Administration has issued warning letters to various drug companies over their promotional materials making inaccurate or incomplete claims. The Los Angeles Times reports that the FDA warnings involve drug company marketing from Eli Lilly, Bayer, Amylin Pharmaceuticals and Cephalon.

For some background on what an FDA marketing enforcement letter is and what it means, look here.

What Drug Companies and Drugs Are involved In Recent Warning Letters?

Eli Lilly was sent a letter by the FDA about their drug Cymbalta. Cymbalta is used for depression, generalized anxiety disorder, diabetic nerve pain and the pain ailment fibromyalgia. The FDA warned Eli Lilly that they did not properly display information about the drug's side effects.

Bayer was warned by the FDA about the marketing of its birth control implant drug Mirena. The agency warned that the marketing of the drug "overstates the efficacy" and "presents unsubstantiated claims."

Amylin Pharmaceuticals' drug Byetta (co-marketed with Eli Lilly) which is used for diabetes has marketing which the FDA views as promoting the drug for unapproved FDA use and also overstated the efficacy of the drug.

Cephalon used a promotional card for its drug Treanda (a lymphoma treatment) that was described by the FDA as "false or misleading because it omits important risk information."

Related Resources:

• FDA: Bayer Illegally Marketing Two Aspirin Drugs (Findlaw's Common Law)
• Cymbalta Warning Letter (in pdf from the FDA)
• Mirena Warning Letter (in pdf from the FDA)
• Treanda Warning Letter (in pdf from the FDA)
• Byetta Warning Letter (in pdf from the FDA)
• Personal Injuries from Dangerous or Defective Products (provided by Gregory S. Young Co., L.P.A.)
• FDA Overview (provided by Goldenberg & Johnson, PLLC)