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.

• A Full Year Continuing Resolution: The Biggest Threat to FDA’s FY19 Funding. The best outcome for FDA is for the Ag/FDA funding bill to pass next week before the expiration of the Continuing Resolution, or at least, soon thereafter. At that point, FDA is likely to receive a nice increase, based on proposed House funding of +$307 million and the Senate of +$159 million. The differences between their positions are described here.

However, should Congress be unable to finish the final FY 19 funding bills (covering about 1/3 of the federal discretionary budget), there is a chance that a new CR would fund FDA and other agencies through the end of the fiscal year (September 30, 2019). In that case, FDA would see none of the “Administration-proposed, House and Senate-funded” increases. The agency would also operate under constraints on the use of existing funds for new initiatives.

This week’s Analysis and Commentary explores, in more depth, the forces that will determine FDA funding in FY 19.

• Alliance Briefing: Dr. Steve Solomon, Director of the Center for Veterinary Medicine, at 3 p.m. on December 6. CVM is responsible for some of FDA’s most important work, despite being a mystery to most stakeholders. In past years, the CVM briefing has been among the most informative ... as Alliance members discover how their group’s interests (and their own pets and meals) are affected by CVM’s actions. Alliance members and media should e-mail Steven Grossman to RSVP or with questions.

• House Appropriations Committee Changes. Unlike the Senate Appropriations Committee, whose membership is likely to be fairly stable, there are significant changes in the House Appropriations Committee. As expected, Nita Lowey (D, NY) will become the first woman chair of the committee. This week, the GOP selected Kay Granger (R, TX) to be the new Ranking Member on the full Committee, replacing Rodney Frelinghuysen (R, NJ), who retired.  The Ag/FDA subcommittee will be chaired by Sanford Bishop (D, GA), but the ranking Republican for the subcommittee has not yet been named.

• CDRH’s Director Shuren Urges More Funds to Identify Early Device Safety Signals.  One of CDRH’s most important new programs -- the National Evaluation System for Health Technology (NEST) -- is set up to use real-world surveillance data to identify and act upon safety signals. Both appropriations and user fee funding support current efforts. Dr. Shuren, in a November 20 statement, stressed the value of funding the $46 million for NEST and other post-market device safety studies that was proposed in the President’s FY 19 budget request for