FDA Testimony to House Subcommittee on March 6

In a prior Analysis and Commentary, we previewed the House appropriations testimony by Commissioner Hamburg and her FDA team given last week. We correctly anticipated that the tone of the hearing would be tough. Full Committee chairman Hal Rogers said:

This is the largest FDA request in recent history ... [the $109.5-million proposed increase for FSMA implementation] will be tough to swallow.

At a different point in the hearing, Subcommittee chairman, Robert Aderholt said that FDA's overall budget request would “disregard the debt crisis facing our nation” and warned that overall funding levels for FDA and USDA are likely to remain “relatively flat at best” for 2016. He laid out three goals he has for FDA and other agencies:

1. Improved management and enhanced accountability

2. Prioritization of funds to most important programs because “all needs can’t be met” and

3. Make sure that food and drugs are safe

Since the overall tone of the hearing was cordial and not confrontational, Commissioner Hamburg was thorough but restrained in responding. Among other things, she pointed out that FDA had re-allocated existing resources wherever possible. She added that only the highest priorities were reflected in the budget request and even those were net of administrative savings and opportunities to re-prioritize program dollars. With regard to the largest proposed increase, food safety, she pointed out that FDA was implementing FSMA with funding levels well below what the Congressional Budget Office had projected would be needed. In sum, this is “a tight, tough budget request” and it reflects “critical items.”

Also, as anticipated, Commissioner Hamburg was asked several questions about drug addiction and diversion and mis-use of prescription and over-the-counter drugs. Chairman Rogers went through some of the history with her, pointing out that his district had been “ground zero” for oxycontin abuse. With specific regard to industry guidance on abuse-deterrent opioids, my understanding is that she promised the regulation would be out in time to avoid penalties to the FDA budget.This upcoming week, on March 12, the Commissioner will testify again -- this time for the Senate Ag/FDA appropriations subcommittee. It is hard to know what to expect, since this will be her first occasion to testify in front of a Republican-led Senate committee. I would expect it to be equally cordial -- the respect on Capitol Hill for Dr. Hamburg and her 6 years at FDA is genuine on the part of Members. Whether it will have the same “don’t expect any new monies” tone is harder to judge. For example, the Senate has generally been more open to food safety funding needs and is very committed to the medical innovation part of the FDA mandate.

Later this week, we will provide more insight on Commissioner Hamburg’s Senate testimony and provide additional perspective on what the hearings tell us about prospects for FDA.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA. We apologize for a slight delay in posting this information to the Alliance web site.