FDA warns Lilly, Amylin over Byetta marketing violations

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The FDA has sent a letter notifying Amylin Pharmaceuticals and Eli Lilly, which co-market Byetta (exenatide) injection, that the company representatives improperly promoted the diabetes drug on June 10 and June 11, 2009, at the 91st Endocrine Society’s Annual Meeting (ENDO) held in Washington, D.C.

As part of its routine monitoring and surveillance program, the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) said it become aware of oral statements made by Lilly and Amylin representatives at the ENDO conference. Several of the statements promoted an “unapproved use, broadened the drug’s indication and overstated the efficacy of Byetta,” according to the agency.

Other statements made by the representatives exaggerate potential weight loss benefits associated with Byetta. Thus, the FDA said that these promotional activities misbrand the drug in violation of the Federal Food, Drug and Cosmetic Act.

The letter indicated that on June 10, 2009, during the ENDO conference, a Lilly representative made the following claims in word or substance to a DDMAC representative:

  • Although Byetta is not indicated for use by itself because it was not FDA approved this way and the FDA requires additional studies, Byetta can be used by itself.
  • There might be managed care, like Medicare or Medicaid issues when prescribing Byetta alone, but “there are ways to deal with that.”

The FDA acknowledged that Byetta was approved for the monotherapy use on Oct. 30, 2009; however, the promotional statements referred to above were made five months before this approval and thus constitute a violation of the applicable law and regulations. “We are particularly concerned by your representative’s promotion of the then-unapproved monotherapy use,” the letter stated.

During the June 10, 2009, discussion at ENDO, the Lilly representative also misleadingly overstated the efficacy of Byetta. Specifically, the representative said that Byetta had a positive effect on cholesterol and triglyceride levels and because of this effect, “cardiovascular benefits” are associated with the use of Byetta. The agency said it is “not aware of any substantial evidence or substantial clinical experience that support the claim that Byetta offers any cardiovascular benefit.”

Finally, according to the FDA, on June 10, 2009, the Lilly representative claimed that 94 percent of patients in a study lost seven to eight pounds without diet or exercise in 30 days. On June 11, 2009, an Amylin representative claimed that 80 percent of patients in a study lost about seven to eight pounds over 30 weeks. The agency said it is not aware of any substantial evidence or substantial clinical experience to support these statements.

DDMAC asked that Amylin and Lilly “immediately cease violative promotional activities for Byetta,” and also that the companies submit a written response explaining these violations and how they will be stopped.