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After Vioxx (rofecoxib) was withdrawn from the market, experts predicted that companies would start having more somber, educational DTC advertisements, and that Congress and the FDA would regulate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

However, “there is no guarantee that the FDA will use these new and expanded powers,” Sugarman-Brozan said, adding that the agency’s enforcement of DTC ads has decreased over the years. So far this year, the FDA has issued one warning or untitled letter, the lowest number since 1997, according to Sugarman-Brozan.

The advertisement was a “reminder ad” for Takeda’s Rozerem (ramelteon) and discussed back-to-school season. However, the FDA issued the letter in March, although the advertisement ran in August and September, Sugarman-Brozan said. “The ad had long since stopped running. It’s arguable the issue was completely moot.”

Takeda also violated the voluntary guidelines it signed with PhRMA to regulate advertisements, showing the industry cannot be relied upon to self-regulate, according to Sugarman-Brozan. PhRMA’s guiding principles are “vague and unenforceable,” he said. “Industry self-regulation is a joke.”

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.

In addition, the agency should fight for mandatory pre-dissemination broadcast review, not a voluntary review, as currently exists, and prohibit reminder advertisements, he said. — Emily Ethridge