FDA warns Lilly, Bayer on improper promos

The FDA has issued another wave of letters demanding changes in drug promotions. Warning letters went out to Bayer, Amylin Pharmaceuticals, Eli Lilly and Cephalon, ordering the companies to stop using DTC ads and other promos that either exaggerate a drug's benefits or downplay its risks--or both. Here are the FDA's beefs:

  • A Lilly print ad for the antidepressant Cymbalta "entirely omits risk information," directing readers to another page for that information, the FDA says. Another Cymbalta ad also downplayed the drug's risk of side effects, the agency adds. A Lilly spokesman tells Reuters that the company is now reviewing all Cymbalta marketing materials.
  • Lilly and Amylin, which co-market the diabetes drug Byetta, were cited for a medical meeting last June where company representatives exaggerated Byetta's ability to help patients lose weight. The FDA also says that the reps exaggerated the drug's efficacy and promoted off-label uses. Both companies say they are taking action in response to the letter.
  • Cephalon got a letter warning it to stop using a dosing card for its lymphoma and leukemia treatment Treanda. Handed out to doctors, the card omitted important risk information, the agency says. The company reports that it has stopped distributing the cards.
  • Finally, in what's surely an unintentionally amusing letter, Bayer has been cited for a program in which its intrauterine device Mirena was promoted in people's homes. The FDA says the script for those events stated that the IUD could help women "look and feel great." But the agency doesn't know about "any evidence suggesting that women who are using Mirena for birth control look great or feel great."

- find links to the warning letters from FDA
- read the Reuters news