Congressmen say major drug companies falling short on DTC requests

WASHINGTON According to House Energy and Commerce Committee chairman Rep. John Dingell, D-Mich. and Rep. Bart Stupak, D-Mich., chairman of the Oversight and Investigations Subcommittee, Johnson & Johnson, Pfizer, Merck, Schering-Plough and Pharmaceutical Research and Manufacturers of America have not gone far enough to accommodate congressional requests regarding direct-to-consumer advertising. The representatives had asked PhRMA and the four firms last month to comply with six specific requests.

After reviewing responses from all recipients this week, Stupak said, “Although we appreciate the drug companies’ willingness to change some of their business practices, they have not agreed to all of our requests, which would protect consumers from misleading and deceptive advertising.”

Dingell and Stupak asked PhRMA and the individual firms to:

• Sign on to the American Medical Association’s (AMA) guidelines on the use of actors and health professionals in DTC ads; 
• Not air DTC ads for any product until a valid outcomes study is conducted and its results released; 
• Not air DTC ads for any new product for the first two years it is on the market, as recommended by the Institute of Medicine; 
• Not encourage off-label uses in any DTC ad; 
• Include the FDA’s toll-free MedWatch number in all DTC ads; and 
• Include any black-box warnings in all DTC ads.

The second and third requests were the most problematic from the industry’s point of view. J& J, Pfizer, Merck and Schering-Plough said a six-month moratorium on DTC ads for new products is generally more appropriate than two years.

As to the second point, “a blanket requirement that DTC advertising await the completion and release of an outcomes study would prevent communication of treatment information to patients who could benefit substantially from controlling certain conditions such as high blood pressure,” Fred Hassan, chairman and chief executive officer of Schering-Plough, said.