A House appropriations proposal provides less FDA funding than the Senate or White House suggested and shaves $16.3 million off the current year's total, a comparison by an FDA support group shows. While the agency's budget would be beefed up by new user fees, the funding available for some of its key programs--including keeping a closer eye on Chinese manufacturing and imports--would be cut.
Some of the spending cutback would come from biologics oversight, which is especially important as the industry moves toward biosimilars. The Alliance for a Stronger FDA also notes that the bill does not fund proposed protections against faulty Chinese imports, a key request from the FDA.
The Alliance includes among its members the industry association PhRMA, as well as many of the world's largest drugmakers such as Pfizer ($PFE), Amgen ($AMGN), Teva Pharmaceutical Industries ($TEVA) and Novartis ($NVS). While the group's chart shows House funding going up for "human drugs" from $478 million this year to a proposed $488 million, the group questions some of the other funding proposals.
In a release responding to the funding proposal, the group lauded the House for stepping away from the enormous FDA funding cuts it proposed a year ago. It goes on, however, to say, "While a significant improvement from last year, we look forward to understanding better the Committee's reasoning in cutting the Center for Biologics Evaluation and Research, as well as the apparent lack of funding for three of the Commissioner's priorities: a China import initiative, funding to implement the Food Safety and Modernization Act, and purchasing scientific equipment to outfit the new biosciences building scheduled to open in FY 13."
The questions provide some insight into the thinking of House members as the House and Senate take up reconciliation of the 5-year reauthorization of user fees, which make up nearly half of the FDA's funding. Some of the money in that proposed legislation would go toward inspecting foreign plants, including those in China, which in recent years have posed a growing challenge to the FDA. The Senate's bill calls for a 6% hike in brand-name drugmaker fees to about $4 billion during the 5-year extension period and a doubling of fees for devicemakers.
- here's the Alliance for a Stronger FDA's opinion
- check out the House's release