"Everything is a high priority" for the FDA today

The FDA’s appearance before the House Ag/FDA appropriations committee started with a big picture juxtaposition. In his opening remarks, Chairman Aderholt (R, AL) made clear that FDA’s small budget request was what was needed as part of a government-wide effort to reduce the annual federal deficit. In his mind -- as he made clear -- FDA is not an exception to the need for government to economize. After the Chairman’s remarks, Ranking Member Sam Farr (D, CA) then made his comments -- opining that FDA has a “big mission and a small budget.”The remainder of the time (about 2 hours) was devoted to Members asking questions about specific issues that concerned them. As a result, we now know that Congress is deeply invested in FDA’s actions or non-actions on: mandatory GMO labeling; the FSMA produce and import safety rules; laboratory developed tests (LTD); the opioid epidemic and the adequacy of FDA’s recent action plan; tobacco regulations dealing with what products are grandfathered and which must be reviewed (so-called “deeming rule”); antibiotic resistance; and dietary guidelines and nutrition facts labeling. All of those topics came up at least three times.The list of additional topics brought up by at least one Member, included: security of food records; genetic engineering; medical gases; pharmacy compounding; DTC advertising; sunscreen labeling; food allergen labeling; social media and pharma advertising; complaints about a permanent birth control medical device; and FDA-NIH relations.Throughout, Dr. Ostroff played the role of the “good soldier.” Every time that a question attempted to get him to say that FDA needs more money, he stressed that the President’s request was all that FDA needed. The only deviation was when responding to a question about whether there were FDA priorities for which money was inadequate, he stated, “As you can tell, everything is a high priority for us.”Among other things, the hearing reinforced an important Alliance message: FDA’s breadth of issues is enormous and the American people (and especially their elected officials) care deeply about how FDA issues are resolved. It remains to be seen whether “caring about FDA issues” is enough to overcome the enormous downward pressure on the FDA’s budget. The Alliance and its members are determined to see that priorities are funded in light of the agency’s growing responsibilities. Please help us by signing up for the Alliance’s lobby day on March 16.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.