Unusual FDA Settlement Includes New Ads for Popular Birth Control Pill Yaz

February 12, 2009 02:14 PM
by Emily Coakley
Pharmaceutical company Bayer is running ads to correct previous claims about its Yaz birth control pill, as the future of direct-to-consumer ads could be in question.

Clarification Ads Part of Federal and State Settlement

Yaz, according to The New York Times, is the nation’s top-selling birth control pill, capturing nearly 20 percent of the market share. Last year Yaz had more than $600 million in sales.

But more than 25 state governments and the FDA took issue with Yaz manufacturer Bayer’s commercials for the drug. “Regulators say the ads overstated the drug’s ability to improve women’s moods and clear up acne, while playing down its potential health risks,” the Times reported.

As a result, the U.S. Food and Drug Administration is now requiring Bayer to submit all of its advertising to the agency before it runs. Under normal procedure, ads are submitted for FDA approval only on a voluntary basis.

Bayer is also airing ads that clarify information on what the medication Yaz does and doesn’t do. These requirements are part of a settlement among Bayer, the FDA and several states. The company did not admit any wrongdoing, but agreed to run new ads.

It’s unusual for the FDA to require corrective advertisements, according to the paper.

Though the Yaz situation might be a classic example of what worries critics of pharmaceutical companies about direct-to-consumer advertising, there are signs that such ads may be becoming obsolete.

Time magazine reports that drug companies spent less on television and print ads in 2008 than they did in 2007. The majority of advertising, or about 85 percent, focuses on prescription drugs that have been on the market for more than a year.

Pharmaceutical companies may be scaling back because of the changed political climate. The Democratic-controlled Congress and White House are interested in lowering health care costs for consumers. Fighting large pharmaceutical companies is seen as one way to achieve that.

Some in Congress want the FDA to prohibit direct-to-consumer marketing for new drugs, and only allow ads after a medication has been on the market for two years.

“Two years will give the FDA and doctors time to see what safety issues arise once a drug is approved. It will also allow adequate time to educate doctors on how to use the new drug,” said Rep. Bart Stupak, a Michigan Democrat who is also chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, in an interview with Time magazine.

Background: History of drug advertising

The FDA’s jurisdiction over prescription drug advertising dates to 1962. Regulations required ads to have information on a drug’s benefits and risks. In print ads, this “brief summary” as it is known, was usually in small print. But pharmaceutical companies had a harder time including brief summaries in radio and television ads, so they tended to stick with other ads exempt from the requirement, according to a 1998 FDA Consumer article.
Those ads, known as “reminder” and “help-seeking” types, could only mention a drug’s name but not say what it was used for, or name a condition without mentioning a specific medication.

The ads, some argued, confused consumers. Women called their gynecologists to see if they were eligible to take Claritin, an allergy medication, after an ad mentioned the name.

Though the FDA also allowed radio and television ads to have an “adequate provision” where people could learn more about the benefits and risks of a medication, the agency never described what that meant.

“So drug companies were not taking advantage of the option because they were uncertain about whether their ads would meet FDA’s standards,” wrote Tamar Nordenberg in FDA Consumer.

In the late 1990s, the FDA took steps to relax the brief summary requirements, making the United States one of two countries (the other is New Zealand) to allow direct-to-consumer prescription drug advertising, according to a report in the New England Journal of Medicine.

Opponents of relaxing the rules said the ads could lead to patients pressuring doctors for unnecessary medication.

The FDA doesn’t require companies to submit ads before they run, but advertisements have to be submitted once a campaign starts.

In 2005, the Pharmaceutical Research and Manufacturers of America announced guidelines for their members. One guideline is to have the FDA approve ads before they run, the Washington Times reported.

Sydney Wolfe, spokesman for Public Citizen, in 2005 told the Washington Times, “The new PHRMA guidelines are a meaningless attempt to fool people into believing the guidelines are stronger than they really are.”

Related Topic: Criticism for FDA amid salmonella outbreak

A recent outbreak of salmonella traced to peanut products from a Peanut Corporation of America plant has renewed complaints that the FDA doesn’t have enough staff to properly monitor the food safety system.

Reference: Medication Web guide


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