FDA's Budget Request Focuses on Essential Functions, Commissioner Tells House Panel

Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....

By Bronwyn Mixter

March 4 — The Food and Drug Administration's fiscal year 2016 budget request is focused on the agency's essential functions such as biosimilars, food safety and drug compounding, FDA Commissioner Margaret A. Hamburg told a House panel March 4.

The FDA's $4.9 billion FY 2016 request includes $2.7 billion for medical product safety issues, Hamburg testified at a hearing on the budget request before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.

The Obama administration's budget proposal, released Feb. 2, seeks $2.7 billion in budget authority and $4.9 billion in total resources for the FDA. The overall FY2016 request is $425 million, or 9 percent, above the FY 2015 levels, according to the proposal. This increase consists of $148 million in budget authority and $277 million in user fees.

“FDA's public health mission is indispensable to the health and well-being of every American,” Hamburg said. “Our budget request plans for efficient spending on essential programs.”

Key Issues 

Hamburg, who is stepping down as head of the FDA at the end of March, said the budget request will support the implementation of key provisions of the FDA Safety and Innovation Act of 2012 (FDASIA) and work on combatting antibiotic resistance.

Creating a biosimilars pathway also has been a priority for the agency, Hamburg said. “We expect very soon to be putting out some important guidance and decisions on biosimilar-related issues.”

The FDA also has been “working very hard” to implement the provisions in the Drug Quality and Security Act (DQSA), Hamburg said. The DQSA was enacted by Congress in November 2013 in response to a deadly fungal meningitis outbreak in 2012 that was linked to contaminated sterile compounded drug products.

Hamburg said the agency has issued several draft guidance documents on drug compounding.

Hamburg also said the budget request will support the implementation of the Food Safety and Modernization Act (FSMA). She said the agency plans to issue final FSMA regulations later this year.

Concerns With Request

Rep. Harold Rogers (R-Ky.), chairman of the full House Appropriations Committee, said he is concerned about the size of the budget request. A $148 million increase “will be tough to swallow,” he said.

Rogers also said he is concerned about the prescription drug abuse epidemic and asked when the FDA would be releasing the final guidance on abuse deterrent formulations of opioids. The draft version of the guidance was issued in January 2013.

Hamburg said the guidance is a “high priority” for the agency.

Rep. Robert Aderholt (R-Ala.), chairman of the subcommittee, said he is concerned about FDA inspections of Chinese facilities.

Hamburg said the agency is making progress on this, but recruiting employees to live in China remains a challenge. Currently the FDA has eight staff members in China with five more pending, she said.

“There are many manufacturers in China that we want to know more about,” she said.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

More information on the hearing is at http://appropriations.house.gov/calendar/eventsingle.aspx?EventID=394021.