FDA seeks to revive ad review program for '09
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The premarket review scheme, under which companies could submit ads voluntarily for swift vetting before broadcast, was withdrawn this year after the president's year-end appropriations bill did not authorize FDA to collect the necessary funds.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. That has some people 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 the Department of Health and Human Services (HHS) itself. Overall, the administration is requesting nearly $2.4 billion, representing roughly a 6% increase over the 2008 fiscal year budget, according to its own figures which Grossman characterized as inflated.
But to ask for $650 million from industry would be too much. “On the appropriation side of the ledger, the real numbers are very poor,” Grossman said.
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. “I honestly think that's possible,” Grossman said. “It's too early to tell.”
This year's budget came in at 10% over the 2007 budget. 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 on Jan. 1).
Compared to last year, when the Prescription Drug User Fee Act was up for reauthorization—a possible distraction for the reauthorizing committees—this year's political environment may prove more conducive to the FDA's funding needs.
Third-party advocates are getting some help in their plea for more money for the agency. Last week the FDA's own scientific advisory board told a House Energy and Commerce subcommittee that weaknesses in FDA staff and IT cripple its ability to screen for tainted food, medical products and devices. And the Government Accountability Office cautioned that the agency lacks the necessary inspectors and computer systems to check overseas sources of drugs, devices and food products.