FDA Slams Bayer; Firm Has a History of Mismarketing OTC Medicines

The FDA slammed Bayer with two warning letters today for allegedly unlawfully selling two unapproved aspirin products. It is not the first time Bayer’s Consumer Health marketers have gone off the rails, raising questions about how professional — or even scientific — the company is when it comes to over-the-counter medicines.

The FDA specifically charged Bayer with mismarketing two aspirin brands, Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin With Heart Advantage. The products “are unapproved new drugs that require an approved new drug application in order to be legally marketed,” the FDA said.

Put aside, for a moment, the fact that Bayer would make the astonishing misstep of moving a new drug product onto the market without FDA approval. Bayer has a history of mismarketing its consumer products. In 2007 the FTC extracted a $3.2 million settlement from Bayer after the company falsely claimed its One-A-Day WeightSmart multivitamins could somehow help with weight loss. (Vitamins do not help with weight loss, duh.)

The 2007 FTC order seems to relate directly to today’s FDA discipline:

Bayer is prohibited from violating the FTC order and from making unsubstantiated representations regarding the benefits, performance, efficacy, safety, or side effects of any dietary supplement, multivitamin, or weight-control product.

I think there’s a strong argument to make that calcium and phytosterols, the two products combined in the offending Bayer aspirins, are dietary supplements, and that today’s FDA move is a violation of the existing FTC order covering the company.

Lest you think that Bayer has somehow just been unlucky with the feds, note that the FTC order came after Bayer had already violated a pre-existing FTC not to market OTC products unless those products can “be supported by competent and reliable scientific evidence.”

That’s not all. At the Council of Better Business Bureau’s National Advertising Division (an ad industry body that acts as a police force for marketers), Bayer has now been the subject of several cases in which the NAD has found the company deceptively marketing its OTC products:

• In July 2007, NAD said Bayer should discontinue its advertising for its All-Day Energy multivitamin, which, er, doesn’t last all day.
• In June 2007, NAD said Bayer was not telling the truth when it said Aleve was the No. 1 medicine among orthopedic surgeons.
• In March 2007, NAD said Bayer was making unsubstantiated claims about rivals to its Ascencia diabetes blood glucose monitor.

A drug company’s sales are almost entirely dependent on the efficacy of its products. There’s only one exception to this rule of the business: When the public begins to doubt that the company tells the truth about its products. (Bayer skirted this territory earlier in the year when its pesticide division was linked to bee deaths. That issue has yet to play out.)

I’ve said it before and I’ll say it again: Something is wrong with the ethics of the marketers inside parts of Bayer’s Consumer Health unit. CEO Werner Wenning (pictured) needs to step in now and fix it before the company finds itself the subject of a systemic collapse of confidence in the Bayer brand.