Lawmakers Question FDA About DTC Website

October 23, 2008
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Rep. John D. Dingell (D-MI), chairman of the US House of Representatives Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), chairman of the Oversight and Investigations Subcommittee, sent letters to the US Food and Drug Administration, Shaw Science Partners, and EthicAd to request information about a new FDA website.

Washington, DC (Oct. 14)-Rep. John D. Dingell (D-MI), chairman of the US House of Representatives Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), chairman of the Oversight and Investigations Subcommittee, sent letters to the US Food and Drug Administration, Shaw Science Partners, and EthicAd to request information about a new FDA website. EthicAd developed the site, “Be Smart About Prescription Drug Advertising-What You Should Know about Prescription Drug Advertisements,” which provides examples of proper and improper direct-to-consumer (DTC) ads.

“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 their letter to Andrew von Eschenbach, commissioner of FDA, Dingell and Stupak noted that EthicAd, a nonprofit organization, was funded by Shaw Science Partners, a public-relations firm for the pharmaceutical industry. “FDA’s website could be viewed as less of a guide to consumers and more of a guide to advertisers,” said Dingell and Stupak in the letter.

According to its website, Shaw Science Partners has helped launch more than 30 drugs, including Ortho Biotech’s (Bridgewater, NJ) “Procrit” and Pfizer’s (New York) “Rezulin.” The Committee on Energy and Commerce has investigated DTC ads for Procrit, and Rezulin was removed from the market because of safety problems.

The lawmakers also wrote letters to Michael O. Leavitt, secretary of the US Department of Health and Human Services (HHS), and Gary S. Balkema, president of Bayer HealthCare (Leverkusen, Germany), questioning the safety and effectiveness of “Bayer Aspirin with Heart Advantage.” The product is marketed both as an over-the-counter medication and a dietary supplement. In the letters, Dingell and Stupak asked why Bayer ignored FDA’s 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. Information about the investigation and the letters to FDA, HHS, Shaw, EthicAd, and Bayer are available on the Committee’s website.

For background on this story, see “New FDA Website Provides Information about DTC Ads.”