Advocacy at a Glance

Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.

• New FDA Commissioner Testifies; Announces Major Accomplishment with End to Hiring Freeze at FDA. Only 2 weeks into his tenure, Dr. Gottlieb testified before the House Ag/FDA Appropriations Subcommittee this week. He covered a wide range of topics in his opening statement and in response to questions (the video is here; the Commissioner’s statement starts at 19:40). Toward the end of the hearing, he announced that the hiring freeze at FDA had been lifted and the agency will be expediting the process of bringing on new hires. In getting the hiring freeze lifted so quickly, Dr. Gottlieb and his team have demonstrated their ability to swiftly accomplish significant internal victories. It gets him out of the blocks well and is an important sign of his ability to move things through the HHS bureaucracy and his attention to administrative matters. As we all know, such matters can be mundane, but are extremely important to the well-functioning of the agency.  While we still need to understand how the hiring will work, the Alliance views FDA workforce issues as one of the most important issues the new Commissioner will face.

• Understanding the Trump FY18 Budget Proposal -- Did FDA Get a 9% Increase or 31% Cut? Depending on how you look at it, FDA was either a big winner or a big loser under the President’s FY 18 budget request. On the one hand, the President proposed a 9% ($452 million) increase in aggregate funding for the agency. On the other hand, the OMB proposal would cut $871 million from the agency’s budget authority (BA) appropriations, which is a 31% decrease. In their place, the Administration proposes more than $1 billion in new additional user fees that Congress is unlikely to adopt.  Our press release provides details and explains our position. This week’s Analysis and Commentary provides some further thoughts and addresses the question: what’s next? 

• Focus on FDA Food Program: Food Funding to Be Cut; Small Partial Offsets Proposed; Dr. Gottlieb Shows Strong Interest in FDA Food Programs. The Administration also proposes to cut funding of food programs by $108 million. Of this, $71 million would come from CFSAN, $32 million from CVM, $3 million from NCTR, and $2 million from the Office of the Commissioner. According to FDA’s budget justifications, the following activities would be reduced: international capacity building to assure safety of imported food; cosmetics safety; research programs related to food safety technology, outbreak response, and FSMA implementation; and support to state and local health organizations. OMB also proposed an increase of $26 million in the animal drug and animal generic drug user fees. While this nets to $82 million, we have no reason to believe those user fee programs will be expanded to provide these monies. So the relevant statistic is a $108 million cut in food programs.
  • Dr. Gottlieb on Food: For our food program stakeholders -- we encourage a close review of Dr. Gottlieb’s testimony this week Thursday, which was previously referenced in this report.  The members of the House Appropriations Agriculture/FDA Subcommittee asked many questions on FDA’s food program, and Dr. Gottlieb showed a commitment to engaging on policy issues in that program.

• House Appropriations Committee Re-opens the Period for Members to Submit Funding Requests. With the release of the President’s Budget Request, the House Appropriations Committee has decided that Members should have an additional opportunity to comment on their funding priorities, a process that otherwise ended in April.  As you talk to Congressmen, urge them to put funding for FDA on their list.  Here are the details. The new deadline for the Agriculture/FDA subcommittee is close of business on June 6. Staff are likely to be working on those requests over the week-long Memorial Day weekend.