FDA Puts Kibosh on DTC User Fee Program

January 23, 2008

Pharmaceutical Executive

Volume 0, Issue 0

In a surprising but not completely unexpected move, FDA announced last week that its Prescription Drug User Fee Act was dead on arrival. Feds cite lack of funding as main reason.

FDA released a statement on its Division of Drug Marketing, Advertising, and Communications (DDMAC) Web site last week stating that the direct-to-consumer television advertisement user fee program was being canceled due to lack of appropriate funds.

When President Bush signed the Prescription Drug User Fee Act in September last year, he included a provision that if FDA failed to raise at least $11.2 million in review fees by January 25, 2008, the program would be null and void.

Additionally, Congress sealed the program's fate on December 26 by declining funding for the user fee program and instead giving $4 million to fund traditional DTC prereviews.

"[FDA] held a party and nobody came," said Lou Morris, former acting director of DDMAC. "They didn?t make their $11 million nut, so they decided they couldn't forward fund it. Therefore, they basically scrapped it—at least temporarily."

This comes less than one month after FDA announced that pharma companies seeking to have their ads reviewed would need to shell out over $40,000 per television spot. In addition, a $165,000 one-time operating reserve fee would have to be paid to get in the front door.

Reactions to the program have been mixed from the get-go. Some industry experts felt that the ads would put pressure on pharma to create better advertising, while others felt that the pay-to-play program could lead to situations where pharma companies refuse to take blame for misleading commercials that get approval.

Some also wondered why the program wasn't set up like traditional user fee plans, where the government prefunds the program and then recoups the funds once the details have been ironed out.

"It's hard to presell something like this," Morris said. Agencies don't want to pay for it until they know how often they are going to use it. People just don?t plan to that level of detail."

Update: The Associated Press announced late Tuesday that Merck/Schering-Plough have voluntarily pulled all consumer television advertising for Vytorin and Zetia, citing "mischaracterization and misinterpretation of the enhanced trial results." No word on how long the ads will remain off the air.