Pharmas heed FDA warnings

Eli Lilly, Amylin, Bayer and Cephalon comply with FDA concerns about drug marketing materials

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WASHINGTON, D.C.—Motivated by warning letters from federal health regulators, Eli Lilly and Co., Amylin Pharmaceuticals, Bayer Healthcare and Cephalon have agreed to correct any inaccurate or incomplete statements appearing in their drug promotion and marketing materials.

The four major pharmaceutical companies came under fire after the U.S. Food and Drug Administration's (FDA) Division of Drug Marketing, Advertising and Communications (DDMAC) disclosed letters issued between mid-December and January relating to over-exaggerating drug benefits, underplaying adverse reactions and making false and misleading statements. While the letters are not legally binding, they do allow the FDA to sue if the drug companies ignore the letters, and allow for the opportunity to voluntarily correct violations prior to any formal enforcement action.

The Federal Food, Drug, and Cosmetic Act requires that all drug advertising contain information in brief summary relating to side effects, contraindications and effectiveness, while refraining from using unsubstantiated claims of superiority.

Rather than answer specific questions, the FDA referred media inquiries to its Web site where the warning letters are posted.

The letter to Indianapolis-based Lilly cites a print advertisement for the antidepressant Cymbalta, which is approved to treat depression, generalized anxiety disorder, diabetic nerve pain and the chronic pain condition fibromyalgia. According to the FDA, Lilly's ad failed to adequately display information about the drug's side effects.

Lilly issued a statement that it is "working to remove the materials from marketing circulation and is committed to providing clinically accurate and balanced promotional materials to healthcare professionals and patients."

The marketing campaign for the diabetes drug Byetta, co-marketed by Lilly and San Diego-based Amylin, allegedly overstated its efficiency, the FDA said.

The FDA reported that on June 10 and 11, 2009, Lilly and Amylin representatives made statements about Byetta at the Endocrine Society's annual meeting, held in Washington, D.C. According to the FDA, a Lilly representative stated 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."

However, "the FDA is not aware of any substantial evidence or substantial clinical experience that support the claim that Byetta offers any cardiovascular benefit," the agency said.

The FDA also alleged that the Lilly representative claimed that 94 percent of patients in a study lost seven to eight pounds without diet or exercise in 30 days due to Byetta. Later, an Amylin representative claimed that just 80 percent of patients in a study lost the same amount of weight during the same period, the FDA said.

Both are wrong, according to the FDA, which said, "These statements misleadingly exaggerate the weight loss demonstrated in clinical trials with Byetta."

Amylin and Lilly said in a joint statement that they "will take action as needed in order to ensure all product communications adhere to regulatory requirements."

Byetta, available in the U.S. since June 2005, is Amylin's leading product, with global sales that rose 25 percent in the second quarter to $194.7 million from a year earlier, according to Bloomberg.

Bayer Healthcare also found itself under the FDA microscope for a scripted presentation on its birth control intrauterine device Mirena, which "overstated its efficacy" and "presented unsubstantiated claims," according to the FDA.

The Mirena promotional live presentation is designed for a consumer audience of "busy moms" and presented in a consumer's home or other private setting by a representative from Mom Central (a social networking Internet site), referred to as "nurse practitioner Barb Dehn."

The presentation states: "Barb is going to kick things off with a discussion about romance and how to find simple ways to reconnect with our partners. One strategy that I recommend for busy couples is choosing a birth control method that allows for spontaneous intimacy and which you don't have to think about every day, such as the intrauterine contraceptive Mirena."

The FDA took issue with this approach, stating, "The above statements clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena. While we note that Mirena does not involve a daily routine and is not a barrier method of contraception, the FDA is not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance or intimacy with their partners."

Furthermore, "patients using Mirena may experience various side effects, such as irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness and acne," the FDA said.

In fact,  "patients should be reexamined and evaluated … four to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated," the FDA stated.
A spokeswoman for Bayer Healthcare Pharmaceuticals said the company discontinued the promotional program and responded to the FDA letter.

Frazer, Pa.-based Cephalon caught the FDA's eye with missing risk information in the company's promotional cards for Treanda, a lymphoma treatment. The drug has been linked to serious infections, skin reactions and other side effects.

Treanda's pocket dosing card was found to be "false or misleading because it omits important risk information associated with the use of Treanda as well as important material information regarding dosing claims made by the card," the FDA said.

Jenifer Antonacci, associate director of product development at Cephalon, says the company "immediately instructed sales people to stop using the card, and is looking at all other marketing materials for Treanda."

Founded in 1987 as a biotech start-up, Cephalon is one of the world's top 10 biopharmaceutical companies, with annual revenues of more than $1.77 billion.

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