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.

• Alliance FY 17 “Ask” for FDA Funding: Despite continued growth in FDA responsibilities, including multiple new initiatives, the President proposed only a $15 million increase over FDA’s FY 16 budget authority appropriation. Spread over a $2.73 billion base, this comes to about an 0.5 percent increase. Food would receive a $26 million increase, offset by flat or lower spending on other centers and a decrease in appropriations support for rent payments. In response, the Alliance released a media release that terms the President’s request as “disappointing” and “alarming.” After having an opportunity to review the President’s proposed budget, the Alliance is recommending that FDA’s BA appropriation grow by $120 million. This would take the agency from the FY 16 funding level of $2.73 billion to a proposed $2.85 billion for FY 17. For a further discussion of the proposed FDA budget and the difference between FDA’s stated needs and proposed expenditures, see last week’s Analysis and Commentary. For additional insights and details about the Alliance’s “ask” for FY 17, see this week’s Analysis and Commentary.

• Alliance’s Rationale for FY17 Recommended Funding Levels: Our rationale is that FDA’s broad and far-reaching responsibilities continue to expand annually. The agency’s larger needs emanate from legislative requirements, increased complexity of science, globalization and homeland security, and emerging infectious disease activities (which includes the Ebola and Zika viruses). Specifically, the Alliance proposes funds to be used to: (1) carry out a number of medical product initiatives, such as biosimilars, drug compounding, and regulatory science (e.g., validating biomarkers, post-market surveillance) and (2) incrementally fund implementation of food safety activities. Also, FDA needs the tools, including effective planning, to continue to manage its growing responsibilities.

• The Moonshot: In addition to this request, we support the $75 million transfer of funds to FDA from NIH under the Administration’s legislative proposal to fund a “cancer moonshot” initiative. If the proposal is adopted and the monies transferred, they would be used to create an oncology center of excellence at FDA. Since these funds are in the President’s proposed NIH budget, we are not counting them as part of the FDA request.

• Member Appropriations Request Deadlines Coming up Quickly. Each year, Senate and House Members can submit funding requests to the appropriations subcommittees for consideration. While “pork” requests are no longer allowed, this is still an opportunity for a Member to indicate support for funding FDA or some particular program or cause within FDA. This year, the House Agriculture/FDA subcommittee has set March 15 as the deadline for receiving requests from Members. The Senate Agriculture/FDA subcommittee has set March 17 as their deadline. Individual Member offices will be setting their own (earlier) deadlines, in order to evaluate all the requests they receive, so that they can make the subcommittee deadline. If you can, please urge Senators and Representatives to include additional funding for FDA as part of their request.

• Alliance Members Needed for Hill Meetings. We have upcoming meetings on the Feb. 23 and 25; and March 1 and 3. Please let Ladd know your availability to join. Please keep in mind that our annual Hill day is coming up on March 16 -- less than a month away.

• Dates are Set for FDA to Testify About the FY 17 Budget Request. In recognition of the tight window to move appropriations bills this year, the House Agriculture/FDA appropriations subcommittee has scheduled Dr. Ostroff and the FDA budget team for a hearing on February 25 at 10:30 a.m. The comparable Senate hearing is scheduled for March 2.

• FDA Releases Glossary About Biomarkers and Endpoints. The Alliance often uses “validating additional biomarkers” as an example of regulatory science activities that should be funded at FDA. Clarifying terms relating to biomarkers and endpoints is part of a new glossary recently released by the FDA-NIH Biomarker Working Group. It’s worth a look!