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FDA warns Bayer on two products

The US Food and Drug Administration has sent a pair of warning letters to Bayer HealthCare taking issue with two of the company's over-the-counter products

The US Food and Drug Administration (FDA) has sent a pair of warning letters to Bayer HealthCare taking issue with two of the company's over-the-counter products: Bayer Women's Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage, which combines aspirin and phytosterols.

The FDA said that any combination of a drug and dietary supplement into a single tablet is considered a new drug and requires marketing approval. As a result, both of the Bayer products are illegal, unapproved new drugs, according to the agency.

The agency previously laid out its position on the issue in warning letters sent to BF Ascher & Co, the maker of a combination over-the-counter (OTC) drug/dietary supplement called Melagesic PM, and to Omni Nutraceuticals regarding its Inholtra Joint Pain products.

In addition to being labelled as pain relievers, both Bayer products are marketed for reducing the risk of heart disease, and the women's product is also sold as helping to fight osteoporosis. "Neither product has been approved by the FDA for such uses," the government agency said, adding: "These drug uses require a healthcare professional's diagnosis and supervision, and therefore these products cannot be labelled for use by consumers and sold over-the-counter."

The FDA said that lack of oversight by a doctor could increase the risk of misuse or overuse of the aspirin-containing products, potentially causing internal bleeding and other adverse events. The agency advises consumers to talk to their doctors about finding alternatives to the products. The FDA acknowledged, however, that it is not aware of any significant reports of adverse events related to either of the products.

The FDA also took issue with the directions and warnings on the products' labels, calling them "inadequate… inconsistent and contradictory".

The warning letters come on the heels of a recent announcement by two democratic congressmen, John Dingell and Bart Stupak, that they had begun an investigation of the company's marketing of Bayer Aspirin with Heart Advantage. To kick off that investigation, the two Michigan lawmakers sent a letter to Bayer earlier this month demanding a range of information, including an explanation of why the company had disregarded the FDA's recommendation against marketing combination products made up of OTC drugs and dietary supplements.

Bayer has been debating the issue with regulators for some time.  In a letter to the FDA's chief counsel in August, the company pointed out that both the FDA and the Federal Trade Commission (FTC) have encouraged industry to educate consumers about the cardiovascular benefits of aspirin. The FDA's warning letter acknowledges that point, but asserts: "Whether or not FDA or FTC have encouraged Bayer… to engage in direct-to-consumer advertising about the benefits of aspirin for cardiovascular disease, we are not aware that FDA has ever encouraged an aspirin manufacturer to market an OTC aspirin product with consumer labelling concerning its intended use for any cardiovascular indication, nor are we aware of any statements by FDA suggesting that it would be legally permissible to market such a product."

In the August letter, Bayer also maintained that a ban on cardiovascular claims in consumer labelling for Bayer Heart Advantage would violate the company's First Amendment rights. "Commercial speech that is false or misleading, or that concerns illegal activity, is not protected by the First Amendment and may be banned," the FDA responds in its warning letter. "Even if specific cardiovascular-related claims are protected by the First Amendment, your labelling is false or misleading for the reasons set forth above, and therefore is not protected by the First Amendment."

29th October 2008

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