Federal health regulators have issued warning letters to Eli Lilly, Bayer, Amylin and Cephanol for making inaccurate or incomplete statements while promoting their drugs.
The Food and Drug Administration on Tuesday disclosed four letters issued to the companies by its marketing enforcement division.
The letter to Lilly cites a print advertisement for the antidepressant Cymbalta, which is approved to treat depression, generalized anxiety disorder, diabetic nerve pain and the pain ailment fibromyalgia. According to the FDA, Lilly’s ad does not adequately display information about the drug’s side effects, a requirement for all pharmaceutical promotions.
The FDA’s letter to Cephalon makes similar complaints about the company’s promotional cards for Treanda, a lymphoma treatment.
The FDA says the card is “false or misleading because it omits important risk information.” The drug has been linked to serious infections, skin reactions and other side effects.
In the letter to Amylin, regulators takes issue with statements made by the company while promoting its diabetes drug Byetta at a conference in Washington D.C. last summer. According to the letter, several statements promoted the drug for unapproved uses and “overstate the efficacy of Byetta.”
Similarly, FDA reviewers said Bayer’s script for a presentation on its birth control implant Mirena “overstates the efficacy” and “presents unsubstantiated claims,” according to the letter.
The four letters were issued on separate dates between mid-December and early January.
The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing and marketing. The letters are not legally binding, but the agency can take companies to court if they are ignored.
Last summer, newly confirmed FDA Commissioner Margaret Hamburg announced several changes designed to speed the pace of warning letters. They included a streamlined review process for sending the letters and shorter deadlines for companies to respond.
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