Oct. 28, 2008
FDA Warns Bayer Over Claims on 2 Aspirin Products
Federal Regulators Call Health Claims Unsubstantiated
Bayer is illegally marketing two aspirin products that make unsubstantiated health claims about fighting heart disease and osteoporosis, federal regulators said Tuesday.
The Food and Drug Administration issued a warning letter to the German conglomerate saying it never received approval for the claims on its Bayer Aspirin with Heart Advantage and Bayer Women's products.
The Heart Advantage product combines aspirin with the plant extract phytosterois, which the label touts as a proven cholesterol-lowering supplement. Bayer Women's combines aspirin with calcium carbonate and is labeled to "fight" osteoporosis.
The FDA warned the company that treatments for heart disease and osteoporosis must be reviewed by government scientists and cannot be sold over the counter. Doctors traditionally recommend aspirin to treat aches and pains and as a blood thinner for patients with heart disease.
"The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process," said Mike Chappell, an FDA associate commissioner.
A Bayer spokeswoman could not immediately provide comment Tuesday morning.
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.
The agency allows traditional pain relievers to be sold over-the-counter without review, as long as they include standard directions and labeling for consumers. But the FDA said Bayer's products overstepped those regulations by claiming that the added ingredients in each medicine help fight specific diseases.
In general, the FDA discourages firms from packaging drugs with dietary supplements because it gives the impression both have been evaluated by the FDA, when in fact, the agency only regulates drugs.
The latest FDA action comes two weeks after Democrats on Capitol Hill first drew attention to the claims on Bayer's Heart Advantage. Reps. John Dingell and Bart Stupak, both of Michigan, earlier this month sent a letter to Bayer's U.S. executives, demanding they turn over any evidence that the product has a positive effect on cholesterol and heart disease.
"It's shameful that consumers have to rely on the oversight function of Congress to make sure drug companies tell the truth in their ad campaigns," Stupak said in a statement accompanying the letter to Bayer. By MATTHEW PERRONE
more information on aspirin:
=> Aspirin-like drugs are 15th leading cause of death in U.S.
=> FDA Plans Warnings for Over-Counter Pain Relievers
=> UK Government bans aspirin for under-16s
October 14, 2008
Lawmakers question ads for Bayer 'herbal' aspirin
WASHINGTON, - U.S. Democratic lawmakers are expanding a probe into direct-to-consumer drug advertisements to include Bayer AG's combination aspirin product, according to letters released on Tuesday.
Bayer's marketing of its Aspirin with Heart Advantage, a combination product that includes a dietary supplement, appears to go against a U.S. Food and Drug Administration request not to advertise such products, said House of Representatives Energy and Commerce Chairman John Dingell.
Advertising the product to consumers "may mislead the public," Dingell wrote along with Oversight and Investigations Subcommittee Chairman Rep. Bart Stupak.
"The FDA strongly recommends that firms refrain from marketing products that combine or co-package drug and dietary supplement ingredients," but would be willing to review them for possible approval, then-Associate Commissioner for Policy Margaret Dotzel said in May 2000.
While aspirin is FDA-approved, dietary supplements such as vitamins and herbs are not subject to agency scrutiny before marketing.
In the letter to Bayer, HealthCare President Gary Balkema, Michigan Democrats Dingell and Stupak asked whether the company planned to seek FDA approval for the combination product. They also called on the company to provide lawmakers with all related records within two weeks.
"The Committee is concerned that your company engaged in DTC (direct-to-consumer) advertising of this product, particularly in light of FDA's recommendation to refrain from marketing combination products," they wrote.
Bayer, in a statement, said its advertisements tell consumers to consult their doctors before using Bayer Aspirin with Heart Advantage and warns it does not replace cholesterol medications. The drugmaker added it was reviewing the lawmakers' letter.
The product is sold without a prescription and contains 81 milligrams of aspirin along with 400 milligrams of phytosterols, a plant-based supplement that aims to reduce bad cholesterol.
The FDA in 2000 began allowing foods that contain plant sterols to include claims on packaging that they can reduce the risk of coronary heart disease because of their possible impact on cholesterol.
Earlier this year the American Herbal Products Association called on the FDA to clarify its marketing policy for products that combine over-the-counter medicines with dietary supplements.
In a separate letter to U.S. Health and Human Services Michael Leavitt, the lawmakers asked whether the FDA or its lawyers were aware of the aspirin marketing or advertisements for any other combination products that include dietary supplements.
FDA spokeswoman Heidi Rebello said the agency received the lawmakers' letter and would respond directly to the committee.
Dingell and Stupak have been investigating whether drug companies have misled the public through consumer-targeted advertisements. Other companies with ads under review include Pfizer Inc, Johnson & Johnson, Merck & Co Inc and Schering Plough Corp.
The pharmaceutical industry, through its trade group, Pharmaceutical Research and Manufacturers of America (PhRMA), agreed to voluntary guidelines in 2005 to address some marketing concerns.
The lawmakers have asked the companies to take further action to curb some advertising practices and have said they are in discussions with PhRMA. (By Susan Heavey, Editing by Richard Chang and Andre Grenon)