Industry Advocate Says Congress, FDA Must Regulate DTC Advertisements

Congress and the FDA are largely ignoring rampant problems with direct-to-consumer (DTC) advertising and need to begin enforcing and regulating the ads, Prescription Access Litigation (PAL) Project Director Alex Sugarman-Brozan said during the Third Annual FDA Regulatory Symposium at Harvard University.

After Vioxx (rofecoxib) was withdrawn from the market, experts predicted that companies would start having more somber, educational DTC advertisements, and that Congress and the FDA would regulate them more, Sugarman-Brozan said.

However, companies continue to spend more money each year on DTC advertising. Last year, pharmaceutical companies spent between $4.7 billion and $5 billion on DTC advertisements, Sugarman-Brozan said. The ads can be very profitable for companies, with typical returns on investment ranging from 150 to 420 percent, depending on the drug, he added.

While there was a “brief surge” of more serious advertisements, now there is a “mixed bag” of educational and entertaining advertisements, he said.

Congress is attempting to regulate DTC advertisements more, such as in S. 1082 and H.R. 2900, the FDA Revitalization Act, which would give the agency the authority to fine companies for deceptive ads, Sugarman-Brozan said. The House bill has a maximum fine of $250,000 and the Senate bill has a maximum fine of $150,000. The bills are currently pending before a congressional committee.

The FDA should increase enforcement, sending letters more frequently and making use of its new authority to fine companies if the bills are passed, Sugarman-Brozan said. When the agency does send a warning letter, it needs to reduce the delay between when the ad runs and when the company receives the letter.