Lawmakers question ads for Bayer 'herbal' aspirin
Tue Oct 14, 2008
WASHINGTON, Oct 14 (Reuters) - 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.
Tue Oct 14, 2008
WASHINGTON, Oct 14 (Reuters) - 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.
