Bayer Consumer Care: Combining The Best Of Both Worlds?

The Consumer Care division of Bayer Corporation, Morristown, NJ, recently introduced Bayer Women's Aspirin Plus Calcium. The product is the first and only product combining 81 mg of aspirin with 300 mg of elemental calcium. This is the lowest dose of aspirin available that can help fight heart disease and as much calcium as an 8 ounce glass of milk to fight osteoporosis by helping maintain strong and healthy bones.

According to Bayer, the product is designed to help women, specifically those age 50 and older, who are on an aspirin regimen (as directed by their physician) to help fight heart disease and get a head start on fulfilling their daily calcium requirements.

Following the trend to target women, Bayer said it brought the product to market because of the two major health threats facing American women today, heart disease and osteoporosis. "Bayer Women's Aspirin Plus Calcium was developed specifically for women to make them more aware of the health risks they face and to both encourage and enable them to address these risks more conveniently by offering aspirin and calcium in a single pill," said the company. The product is distributed nationally and in stores is shelved in the analgesic category within the Bayer Aspirin regimen line-up.

In terms of regulatory issues, Bayer did not have to contend with FDA as aspirin plus calcium is already an established and approved FDA combination that has been used for decades. Additionally, the company said, "Bayer has marketed an 81 mg aspirin regimen product with 100 mg of calcium as a buffering agent since 1996. With Bayer Women's Aspirin Plus Calcium, Bayer has simply increased the amount of calcium in the product to 300 mg to be of specific benefit to women. As such, the combination does not require FDA approval because it is not a new drug. The product is authorized by the existing OTC monograph."

As for being compared to other products in the market that have launched as dietary supplement/OTC combinations, Bayer said there are two key issues FDA has cited against drug/dietary supplement combinations and while they may apply to combination products challenged by FDA, they are not applicable to Bayer's new product. "Those drug/dietary supplement combinations are inherently inconsistent. The drug or pain reliever is meant for use on a short term basis and the supplement on a long term basis. This does not hold true for Bayer Women's. The aspirin in the product, like the calcium, is for long term aspirin regimens." The second issue, according to the company, is whether the supplement may interfere with the efficacy of the drug. "While (to our knowledge) there has been no scientific proof offered to substantiate the efficacy of the challenged acetaminophen combination products, calcium and aspirin have well established ingredient profiles. Moreover, to ensure that the presence of extra calcium does not interfere with the efficacy of the aspirin in the Bayer Women's product, we conducted an aspirin plus calcium platelet aggregation study, which confirmed that Bayer Women's is just as effective as regular 81 mg aspirin without calcium. The calcium does not interfere with the ability of aspirin to irreversibly inhibit platelets to prevent clotting," the company said.

Bayer has included both a Drug Facts panel as well as a Supplement Facts panel. The Drug Facts panel is FDA required and the Supplement Facts panel labeling is in accordance with nutritional supplement labeling guidelines. Bayer is making an osteoporosis health claim for Bayer Women's Aspirin Plus Calcium under the Nutrition Labeling and Education Act (NLEA).

Bayer seems to be the first to market to circumvent FDA involvement but will it be the only product in the company's arsenal to combine an OTC/dietary supplement ingredient? That remains to be seen. -R.M.