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.

• Continuing Resolution Expires March 23: Unclear Whether Congress Can Avoid Brinksmanship.  Last week, we suggested that complications were emerging and that there was no longer a straight or clean path to completion of FY 18 appropriations. This proved to be the case. The House had hoped (and was supposed) to vote on an Omnibus bill this week, but didn’t. The text of an Omnibus bill is expected to be released this coming Monday, but there is already talk it might slip to Tuesday. With a Friday midnight deadline next week and the need to move legislation through both the House and Senate, this is definitely a tight schedule. The hold-up does not appear to be appropriations levels, but rather policy riders, earmarks, and what non-appropriations bills will be added to the package. We agree with most analysts who are saying there is little risk of a government shutdown, but are less certain that Congress can avoid needing another short-term CR (perhaps only 2 or 3 days).

• Highlight of CDER Priorities for FY 19: Alliance Meets with Dr. Woodcock. This week, a team of nearly 20 Alliance members and staff met with Dr. Janet Woodcock, director of FDA’s Center on Drug Evaluation and Research. Among other things, she highlighted the breadth of opportunities at CDER to improve safety and efficacy while reaching better decisions sooner. Along with our meeting the prior week with Dr. Shuren, head of CDRH (summarized here), we are getting the picture of an FDA poised for great things, but just needing the resources to get there. Dr. Woodcock’s remarks are covered in more detail in this week’s Analysis and Commentary.

• Deadlines for Senators to Receive Your Input on FY 19 Appropriations for FDA. A few weeks ago, we described how members of the House appropriations committee, are open to receiving your input on funding priorities for FY 19. Those deadlines have all passed, but a similar process is taking place in the Senate. End dates for Senators to receive comments are listed here. (Thank you to the Coalition for Health Funding for compiling the list.) We suggest prioritizing the members of the Ag/FDA Appropriations Subcommittee (here) and then the members of the Appropriations Committee (here). The Alliance’s ask -- that we hope you will convey to these Senators -- is described here. You can also see the “ask” illustrated in submissions we made to the House (see here and here).

• Appropriations Testimony “For the Record” Due Soon. Testimony by outside witnesses on FY 19 FDA funding are due in the Senate on March 30; directions are here. The House testimony is due April 13; directions are here. We encourage Alliance members to develop their own testimony for submission based on the Alliance’s “ask”. For those who want to see our testimony first, we expect to distribute it with next week’s Friday Update.

• Interested in Alliance Membership? The Alliance’s effectiveness is directly tied to the depth and breadth of our membership, so if you are not a member please consider joining. Our membership includes, among others, consumer and patient groups, health professions societies, trade groups, industry, and individuals. For more information, please contact Steven Grossman.