ARTICLE
16 March 2015

FDA's 2016 Budget Request Focuses On Biosimilars, Food Safety, And Drug Compounding

JD
Jones Day

Contributor

Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
FDA Commissioner Margaret Hamburg testified regarding the agency's $4.9 billion request, focused on biosimilars, food safety, and drug compounding.
United States Food, Drugs, Healthcare, Life Sciences

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.

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More