The FDA’s plan for premarket review of TV ads, scrapped in2008, might still happen in 2009. The agency’s proposed 2009 budget includes anincrease 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 newappropriations. The better part of the proposed total increase consists ofabout $57 million in payments from industry. So-called user fees total about$607 million in the draft budget, including $511 million for drugs andbiologics, according to estimates recently posted to the FDA website.

The review scheme, under which companies could submit adsvoluntarily for swift vetting before broadcast, was withdrawn this year afterthe president’s year-end appropriations bill did not authorize FDA to collectthe necessary funds. Industry is again being called on to foot the bill for theprogram, as well as a bigger share of the agency’s budget. This has someconcerned.

“[The administration] only proposed about half of what theagency needs just to break even,” said Steven Grossman, executive director,Alliance for a Stronger FDA. “Nonetheless, by using user fees…they managed toget the [increase] up to $130 million, which makes it look like at a minimumthey’re beating inflation. But everything is not on the appropriations side ofthe 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 Grossmancharacterized 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 budgetcame in at 10% over last year’s. The boost, which came in a flat year for manygovernment agencies, reflected advocacy at work, said Grossman, and followed aconcerted lobbying effort by the Alliance and its one-time counterpart, theCoalition for a Stronger FDA (the two groups merged Jan. 1).