FDA budget bids to revive DTC review
The FDA's plan for premarket review of TV ads, scrapped in 2008, might still happen in 2009. The agency's proposed 2009 budget includes an increase of $14 million for DTC TV ad review.
It's part of a $984 million budget for drugs and biologics. But the total financial plan for FDA authorizes only $51 million in new appropriations. The better part of the proposed total increase consists of about $57 million in payments from industry. So-called user fees total about $607 million in the draft budget, including $511 million for drugs and biologics, according to estimates recently posted to the FDA website.
The review scheme, under which companies could submit ads voluntarily for swift vetting before broadcast, was withdrawn this year after the president's year-end appropriations bill did not authorize FDA to collect the necessary funds. Industry is again being called on to foot the bill for the program, as well as a bigger share of the agency's budget. This has some concerned.
“[The administration] only proposed about half of what the agency needs just to break even,” said Steven Grossman, executive director, Alliance for a Stronger FDA. “Nonetheless, by using user fees…they managed to get the [increase] up to $130 million, which makes it look like at a minimum they're beating inflation. But everything is not on the appropriations side of the ledger.”
The Alliance plan calls for more money from HHS. Overall, the administration is requesting nearly $2.4 billion, representing roughly a 6% increase over the 2008 fiscal year budget, according to figures which Grossman characterized as inflated.His group proposes a $380-million budget increase for 2009—seven times the administration request, but less than 20% above the current year's appropriation. This year's budget came in at 10% over last year's. The boost, which came in a flat year for many government agencies, reflected advocacy at work, said Grossman, and followed a concerted lobbying effort by the Alliance and its one-time counterpart, the Coalition for a Stronger FDA (the two groups merged Jan. 1).