Bayer Bucks the System; FDA Warns Bayer on Two Aspirin Products
Big Pharma’s dirty pool tactics don’t just extend to prescription drugs. Bayer has some nerve in marketing two over-the-counter products without the FDA’s approval. Of course, in countless cases that approval means absolutely nothing, given the plethora of drugs that have been recalled years after the FDA’s blessings.
The FDA has warned Bayer numerous times about its marketing efforts and claims for these products. Because the FDA does not scrutinize supplements, Bayer pulled a fast one by combining aspirin with supplements and promoting health benefits through television and other advertising venues. The two products are “Bayer Aspirin With Heart Advantage” which is marketed to help treat heart disease, and “Bayer Women’s Low Dose Aspiring + Calcium,” marketed to treat osteoporosis. A spokesperson for the FDA says that misuse or overuse of aspirin products can result in internal bleeding or other side effects.
The Wall Street Journal article below talks about the FDA’s numerous warnings, yet Bayer continues to boldly market these products, stating that it stands behind their claims. What does this say about the FDA and its authority over big pharmaceutical companies? Not much, in my opinion.
FDA Warns Bayer on Two Aspirin Products
Wall Street Journal
WASHINGTON -- Pharmaceutical giant Bayer AG has received warnings from federal regulators for illegally marketing two unapproved over-the-counter medicines combining aspirin with dietary supplements.
Bayer's "Bayer Aspirin With Heart Advantage" and "Bayer Women's Low Dose Aspirin + Calcium" are drugs and require Food and Drug Administration approval before being marketed, the FDA said in two letters posted on its Web site Tuesday. The letters are dated Monday.
The two drugs combine Aspirin with over-the-counter dietary supplements. Bayer's Women's combines Aspirin with calcium. Bayer Aspirin with Heart Advantage combines Aspirin with phytosterols, which Bayer says help lower cholesterol.
Products that combine drugs and dietary supplements require FDA approval before they can be marketed, even if the drug, in this case Aspirin, is already approved.
Bayer has been marketing Aspirin Heart Advantage since earlier this year, while Bayer Women's Low Dose Aspirin + Calcium has been on the market since 2002. A company spokeswoman said Bayer was in the process of reviewing the FDA letters and will respond to the agency.
She said Bayer stands behind "both products and all the marketing claims that we make in their support."
Bayer has faced criticism from lawmakers over television ads for Bayer with Heart Advantage. Earlier this month, leaders of the House Energy and Commerce Committee said Bayer appeared to be ignoring FDA recommendations that companies refrain from marketing products that combine drugs and dietary supplements.
The FDA doesn't closely scrutinize dietary supplements for safety and effectiveness, and lawmakers are concerned that a product containing an FDA-approved drug and a supplement misleads people to believe the supplement has also been vetted.
"The marketing of these unapproved drugs is troubling," said Janet Woodcock, who heads the FDA's drug and research center, in a statement. "The overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events."
The FDA says, however, it isn't aware of any significant adverse events associated with the drugs.
Bayer with Heart Advantage is marketed to help treat heart disease, and Bayer Women's is marketed to treat osteoporosis. Because the drugs purport to treat a disease, they should be taken under the diagnosis and supervision of a health care professional, which is impossible for a drug that can be bought without a prescription, the FDA said.
Furthermore, the FDA said the labels for the drugs send a "mixed message about the products' purposes and the length of time for which the products can be safely used."
Write to Jared A. Favole at jared.favole@dowjones.com
©2008 Angel Reyes