The United States Congress is gearing up to reauthorise the Food & Drug Administrations ability to collect fees from drug manufacturers. FDA and the pharmaceutical industry have already worked out an agreement regarding fees for fiscal 2018 to 2022. But that plan is now up in the air because President Donald J. Trump wants to boost FDA user fees by $1 billion in fiscal 2018. Lawmakers must renew FDAs authority to collect fees from industry every five years. FDAs current authority to collect such fees for prescription drugs, medical devices, generic drugs, and biosimilars is set to expire on 30 September. Industries regulated by FDA typically contribute about $2 billion to FDAs budget each year to help pay for safety and efficacy reviews of new products such as pharmaceuticals and medical devices. Industry-paid user fees make up about 43% of the agencys total annual budget, which has been hovering around $4.7 billion for the past few years. The Trump Administrations budget blueprint, which was released on 16 March, proposes to recalibrate FDA user fees to replace the need for new budget authority to cover pre-market review costs. The biomedical community is raising concerns about making such a change at this stage in the process, saying it could prevent Congress from passing legislation before the end of September. The Alliance for a Stronger FDA, an advocacy group of drug manufacturers and patient organisations, calls the Presidents proposed budget neither wise nor realistic. The proposal is unrealistic because the drug and device industries have recently completed user fee agreement negotiations with FDA, the group says. User fees have always been intended to supplement the agencys appropriation, never to replace it. The House of Representatives and the Senate held hearings this month about renewing FDAs authority to collect industry-paid user fees. At a hearing on 21 March of the Senate Health, Education, Labor & Pensions Committee, Chairman Lamar Alexander (R-Tenn.) stressed the importance of reauthorising an agreement by late July. If we do not move quickly, FDA could be forced to send layoff notices to more than 5,000 employees, Alexander said. More hearings on the topic are scheduled for later this month and April.
Chemical & Engineering News, 27 March 2017 ;http://pubs.acs.org/cen/news ;