FDA Not Likely to Get Full $4.9 Billion Budget Request

Republican lawmakers warned the FDA to expect fiscal year 2016 funding levels to be in line with this year’s $4.4 billion, not the full $4.9 billion in funding that President Barack Obama asked for in his budget request.

Rep. Hal Rogers (R-Kan.), chair of the Appropriations Committee, called the FDA’s request the largest in recent history and difficult to swallow.

Congress gave CDER $1.338 billion and CBER $344 million for the current fiscal year, which ends September 30.

For FY 2016, the FDA is asking for a $277 million hike in allowed collection of total user fees, Hamburg told the committee. The agency is also looking for an $84.8 million increase in funds for medical product safety efforts.

Neither Robert Aderholt (R-Ala.), chair of the subcommittee that oversees the FDA, nor fellow subcommittee members offered any specifics on areas where cuts might be seen during Wednesday’s hearing.

Most of the focus on new funding in this budget proposal is for food and veterinary medicine, with the FDA seeking only minor increases for CDER and CBER. Under the president’s proposal, CDER’s funding would increase less than one percent, to $486 million, while CBER’s would rise two percent to $215 billion.

User fee revenue for drug reviews would also increase, with drug company user fees going from $798 million to $826 million and generics fees increasing to $320 million, from $312 million. Fees for biosimilars would grow from $21 million to $21.5 million.

Hamburg said the agency is prioritizing its most urgent needs in its budget request.

The subcommittee spent most of its time drilling outgoing FDA Commissioner Margaret Hamburg on the status of the agency’s guidance on curbing prescription opioid abuse and biosimilars. Hamburg said both can be expected soon. — Bryan Koenig