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.

• DOD/Labor-HHS/CR to Be Signed by President; No Government Shutdown. President Trump signed the minibus bill on September 28, funding DOD, Labor-HHS, and parts of the government that have not yet been funded for FY 19. The CR will extend through December 7, by which time Congress hopes to be done with remaining appropriations bills. The likely sticking point is the appropriations bill covering the Department of Homeland Security, which is the battleground for the funding of border security agents and the proposed Southern wall.

• FDA Appropriations in Limbo; Most Likely to be Funded Through the CR. Negotiations continue on the four-bill minibus that includes funding for the Department of Agriculture and FDA. While several Members have been optimistic, there is almost no time left for the House to act before it goes on recess. Our assumption is that FDA will be funded by the CR through early December, but the four-bill minibus (unlike Homeland Security) should have no problems passing in the post-election session. A CR is undesirable because FDA would not have access to new funds and faces some potential limitations on new initiatives.

• CDER Director Janet Woodcock Talks with Alliance Members at 9/21 Meeting.This week’s Analysis and Commentary describes the event and some of the issues that Dr. Woodcock addressed during extended discussion and Q&A.

• FDA Moves Forward on Advanced Manufacturing Technology Initiatives.  FDA announced five grants to higher education institutions and non-profit organizations to study and recommend improvements for the continuous manufacturing of biological products, as well as similar innovative monitoring and control techniques. The agency believes that advances in manufacturing can enable the full potential of very novel technologies like cell and gene therapies, and new vaccines.

• Five Appropriations Bills Enacted Before October 1 Is a Rare Feat.  Courtesy of the House Budget Committee: between 1977 and 2017, Congress enacted 176 continuing resolutions. The failure to pass a government-wide CR has resulted in 19 government shutdowns. The last time Congress fully followed “regular order” -- a bicameral Congressional resolution followed by all 12 appropriations bills before the beginning of the new fiscal year -- was 1995.  Even passing five bills (with no budget resolution) has not occurred in recent years. A bipartisan, bicameral Joint Select Committee on Budget and Appropriations Process Reform is currently looking for solutions to make the process more efficient, but will miss the deadline for releasing its recommendations.