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Dingell, Stupak Continue DTC Ad Investigation

Lawmakers question new FDA Web site on DTC; Bayer Aspirin with Heart Advantage

WASHINGTON, Oct. 14, 2008 –Reps. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Oversight and Investigations Subcommittee today sent five letters as part of their continued investigation into direct-to-consumer (DTC) advertising of prescription pharmaceutical products.

“We have serious concerns that the leading pharmaceutical companies do not share our commitment to providing consumers with accurate information about drug therapies,” said Dingell. “As certain drug companies place corporate profits above patient health, it appears they are even willing to ignore FDA recommendations.”
In letters sent to Andrew von Eschenbach, Commissioner of FDA, and Michael S. Shaw, President of Shaw Science Partners and Executive Director of EthicAd, the lawmakers question the development of a new Food and Drug Administration (FDA) DTC Web site, “Be Smart About Prescription Drug Advertising – What You Should Know about Prescription Drug Advertisements,” which provides consumers with examples of proper and improper DTC ads. The letters follow a news report from the Center for Science in the Public Interest indicating that the site was developed by EthicAd, a non-profit organization funded by Shaw Science Partners, which is a public relations firm for the pharmaceutical industry. According to the Shaw Science Partners Web site, the company has worked on the launch of more than 30 drugs, including Procrit, whose DTC advertisements have been investigated by this Committee, and Rezulin, a drug that was removed from the market for safety problems.

Dingell and Stupak are also questioning the safety and effectiveness Bayer Aspirin with Heart Advantage, which claims to be both an over-the-counter medication as well as a dietary supplement. In letters to Michael O. Leavitt, Secretary of the U.S. Department of Health and Human Services (HHS), and Gary S. Balkema, President of Bayer HealthCare LLC, the Chairmen inquire why the company has ignored FDA recommendations to refrain from marketing such combination products.

“It’s shameful that consumers have to rely on the oversight function of Congress to make sure drug companies tell the truth in their ad campaigns,” Stupak said. “We will continue our work to make certain that drug companies market their products properly and protect American consumers from misleading and deceptive advertisements.”

The Committee on Energy and Commerce began investigating misleading and deceptive DTC advertising in January 2008. Both the Jarvik Lipitor ads and the Vytorin “Food and Family” ads were voluntarily withdrawn shortly after the investigation began.

On May 8, 2008, the Oversight and Investigations Subcommittee held a hearing on DTC advertising, which focused specifically on three broadcast DTC ads: Pfizer’s ads for Lipitor featuring Dr. Robert Jarvik, Merck/Schering-Plough’s “Food & Family” ads for Vytorin, and Johnson & Johnson’s ads for Procrit.

Contact: Jodi Seth or Brin Frazier, 202-225-5735

Posted: October 2008