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A new bill was recently passed which gives the FDA power to require drug companies to submit TV ads for review before they run. The bill doesn’t go far enough, however, since the Agency can only recommend changes, not demand them. Early drafts of the bill gave the FDA authority to block a drug company from advertising medications that contained serious safety concerns. Consumer drug ads have drawn criticism since a series of high-profile drug recalls featured in blockbuster ad campaigns, including the recall of Vioxx from the market in 2004 and Bextra in 2005. Direct-to-consumer advertising for Celebrex was suspended for a period of time following hearings on the safety of Cox-2 inhibitors in early 2005 ( Critics argued that the industry used TV ads to push new drugs into widespread use before their full safety risks were disclosed or discovered.

The bill does allow the FDA to levy fines for ads that are found to be false or misleading. The fines will amount to $250,000 for the first violation in any three-year period, not to exceed $500,000 for any subsequent violation in a three-year period. The FDA will also be able to require ads to disclose specific safety risks and clear statements about potential side effects. With newer drugs, the agency can also ensure that ads disclose the date the product received FDA approval.

In this latest battle to limit FDA oversight, pharmaceutical companies found powerful allies among media and advertising firms. The idea that regulators would be able to block ads about a new drug was a potential business disaster-in-the-making for the advertising industry, especially since pharmaceutical companies have grown to be ranked in the top 10 largest and fastest-growing advertisers in the country, spending $5.3 billion in the U.S. ad market in 2006 alone. The final bill was viewed as a “success for the entire advertising community,” according to Dan Jaffe, executive vice president of the Association of National Advertisers.

Over the years, direct-to-consumer spending has become a big issue in Alley, Clark, Greiwe & Fulmer’s pharmaceutical mass torts practice. Drugs that are potential blockbusters (usually ones that are “me too” drugs that are marketed to the masses for minor and common ailments) are the drugs that are most likely to become the subject of widespread product liability litigation when safety issues arise. Vioxx, Baycol, Redux, Prempro, Ortho-Evra, and Bextra are good examples. Direct-to-consumer advertising absolutely increases demand for a drug. If it did not, then drug companies would not pour so much time and money into slick television and print advertising campaigns. Through advertising, patients are being driven into their physician’s offices and demanding prescriptions based upon thirty-second sales pitches that provide little (if any) meaningful information about benefits of the drug versus risks. Physicians are also being inundated with overly positive marketing messages at the same time from pharmaceutical sales representatives who visit their offices each week.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

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