At the FY2016 Budget Hearing for FDA before a House Appropriations Subcommittee, FDA Commissioner Margaret Hamburg testified regarding the agency's $4.9 billion request, focused on biosimilars, food safety, and drug compounding. The request is for a 9 percent increase over the FY2015 budget. Dr. Hamburg, who is resigning this month, testified that the requested budget would support several important agency initiatives including the implementation of key provisions of the FDA Safety and Innovation Act of 2012 (FDASIA) and the Drug Quality and Security Act (DQSA), efforts to fight antibiotic resistance, and further development of biosimilars guidance. Several members of Congress expressed reservations about the request, including Rep. Harold Rogers (R-KY), chairman of the full House Appropriations Committee, who voiced concern about the amount, and Rep. Robert Aderholt (R-AL), chairman of the subcommittee, regarding the shortage of FDA staff to inspect Chinese facilities.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
