FDA user fees for foreign inspections at risk

HHS Secretary Kathleen Sebelius

The financial maze facing Congress in the form of across-the-board cuts in funding of federal agencies is wreaking a very particular havoc at the FDA. The Office of Management and Budget (OMB) has said that the financial agreement that Congress entangled itself in nearly two years ago affects not only federal funding but also the industry-paid user fees that make up a significant amount of the FDA budget. The fees are also subject to the 8% cut. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius has pointed that out to members of Congress who are trying to reach an agreement that would change the funding process before it kicks in next month, Regulatory Focus reports. The cuts are expected to be hard on all agencies, but threaten to undermine the FDA's efforts to expand inspections of foreign manufacturing plants. New fees starting this year from generic drugmakers are to be used in large part to fund that effort. Regulatory Focus says that the cuts would mean a loss of about $200 million from its base budget and an estimated $112 million (annualized) in lost users fees. Story | More