Upcoming ... Commissioner Hamburg's "Last Stand"

On Wednesday, March 4, the FDA will be testifying in the House on its FY 16 Budget Request. Representing FDA will be: Dr. Margaret Hamburg, Commissioner, Food and Drug Administration, Jay Tyler, Chief Financial Officer, FDA, and Norris Cochran, Director, Office of Budget, Assistant Secretary for Financial Resources, DHHS. As usual, it will begin with opening statements from Members who are present, followed by a statement from Commissioner Hamburg. That is usually followed by a vigorous Q&A, with subcommittee members asking tough questions about the agency, its actions, and how money is proposed to be spent.Based on the hearing this week with USDA’s undersecretary for food safety, we can make a few assumptions. We expect the committee will be looking for ways to achieve economies—either by making existing staff more productive or by eliminating the need for staff and programs.  This view is reflected in the comments of subcommittee Republican Kevin Yoder of Kansas (as quoted here):

I think most of us would certainly believe that government is too large, too expensive, too bureaucratic. So opportunities to reduce some of those inefficiencies, while still providing a good service to our constituents, would be a high priority.

We expect, as well, that Commissioner Hamburg will have to answer some of the same questions as USDA about the proposed food safety merger: her views, likely cost savings, scientific rationale, etc. USDA’s answers appear to have been quite general and admitted to a large degree of incompleteness in the details of the proposal. It will be interesting to see if the Commissioner provides more details.What else? We would expect questions about the multiple laws that FDA is implementing (tobacco, food safety, biosimilars, FDASIA including generic user fees, compounding, drug quality and security, and sunscreen monograph). The agency is also likely to be asked about globalization, particularly the safety of imported goods, the effectiveness of overseas offices, and degree of cooperation from foreign governments, such as China and India. Other questions are likely to touch on medical countermeasures, antibiotic resistance, counterfeit drugs, the response to Ebola, and nutritional standards.  We suspect the agency will not be asked about pending legislation, such as 21st Century Cures, because the jurisdiction of the committee only extends to the funding of enacted programs.It is also safe to assume that there will be multiple questions about a perennial House issue: drug addiction and especially FDA’s role in making it harder to divert or misuse prescription and over-the-counter drugs. This is a particular concern of full Committee chairman, Hal Rogers of Kentucky. We will be watching closely the subcommittee’s questions and FDA’s answers concerning Section 734 of the omnibus appropriations bill. This provides an unusual (if not unprecedented) Congressional challenge to FDA to complete a guidance for industry in the area of evaluating and labeling of abuse-deterrent opioids. Specifically, if the guidance is not finalized by June 30, 2015, then $20 million will be transferred from the Commissioner’s office to the FDA Office of Criminal Investigations for the purpose of assisting Federal, state, and local agencies to combat the diversion and illegal sales of controlled substances.Next week, we will give you a run-down on what the committee actually asks FDA and how the agency responds.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.