Hill Day Coming at the Perfect Time. Now We Need You to Participate

Hill Day Coming at the Perfect Time. Now We Need You to Participate (Tuesday, March 19). The President’s FY 20 budget request for FDA is an excellent starting point for what we hope will be a year of growth for FDA. We are one of the few splashes of black ink in a Presidential budget request that is otherwise a sea of red ink for non-defense programs. It’s a vote of confidence in FDA, but it will mean nothing if Congress isn’t equally committed to strengthening FDA. Fortuitously, our big Hill Day is next Tuesday and we have an important message:

assuring safe food and safe and effective medical products are core functions of government, not unlike assuring safe air travel and providing for the common defense. Increased investment in FDA will yield substantial benefit to the American people.

Right now, we need a lot of help from Alliance members and other FDA advocates. Seventy (!) Congressional offices have agreed to meet with us next Tuesday, providing a priceless opportunity to deliver our message ... widely and all in one day. We know it is a busy time of year, but we need your help to assure that we have robust and diverse teams on Hill Day. We need more of you to look at your calendars and decide that you can spare a whole day (or even a half-day) next Tuesday to support FDA. RSVP today!

FDA Gains Substantially Under the President’s Request; NIH, Other Public Health Agencies Proposed for Cuts. The president delivered on his promise to propose tens of billions of dollars in cuts to non-defense discretionary (NDD) spending. As a consequence, there is some proposed growth in homeland security and VA, but the rest of NDD spending would be subject to dramatic cuts. Among public health programs, cuts are proposed of $4.7 billion to NIH and $750 million to CDC. Presumably, both of those agencies will be restored if there is (as expected) a Congressional agreement to substantially increase the spending ceiling for NDD program.FDA is proposed for an increase of $362 million above the FY 19 Continuing Resolution level (the base used in the President’s Request), which is nearly $260 million above the FY 19 final enacted spending level. The Alliance for a Stronger FDA commented:

we are quite pleased with the proposed increase in appropriated funding for FDA. We thank the Administration for its continuing strong support of FDA. The agency will be able to apply new monies to important programs that benefit the American people, as well as hire needed scientific personnel to carry out the FDA’s far-ranging mission.

The Alliance is looking forward to publication of the Congressional Justification (CJ) for FDA during the week of March 18. It will contain the numbers needed to do accurate analysis and is essential to establishing the Alliance’s FY 20 “ask.” This week’s Analysis and Commentary provides somewhat more details while we wait for the CJ. It also lays out some of the barriers to a smooth path for FY 20 appropriations.

House Appropriations Committee Sets April 5 Deadline for Public Witness Testimony for the Record. Every year, there is an opportunity for public (non-governmental) organizations to submit testimony for the Appropriations Committee record. This year, the Ag/FDA subcommittee has set Friday, April 5 as the final day to submit testimony. The key documents are Instructions for Public Witness Testimony and Public Witness Truth in Testimony Form. We encourage Alliance member organizations to submit Statements for the Record. If you need additional information or assistance, contact Roger Szemraj.

Dr. Ned Sharpless, NCI Director, Appointed Acting FDA Commissioner. With Dr. Gottlieb set to leave FDA in early April, Secretary Azar has named Dr. Ned Sharpless, the director of the National Cancer Institute, to be the Acting Commissioner until a new commissioner is nominated and confirmed. NCI is known to work more closely with FDA than many of the other NIH institutes. The Alliance has commented:

Dr. Sharpless brings a varied background in academia and government and is also an inventor and innovator with industry experience. All of this makes him an exceptional choice for acting FDA Commissioner and we look forward to working with him to continue to build and strengthen the agency.

House Plans to Complete All Appropriations Bills Before July. House Majority Leader Steny Hoyer (D-MD) told the House Budget Committee that he has “reserved all of June to pass every appropriations bill by June 30." He recognized that this probably depended on a Congressional deal to raise the spending ceilings set by the Budget Control Act of 2011. To accomplish this, he called upon House and Senate Budget committee members to work together to resolve this early and not leave it for a difficult end-game.  While it would be a great surprise if all of the appropriations bills were completed before July, his statement represented a symbolic call for bipartisan budget and appropriations work that would assure that FY 20 will not become a repeat of FY 19 deadlocks and the longest shutdown ever of the Federal government. Hoyer’s testimony is here. This week’s Analysis and Commentary looks at several barriers to a smooth FY 20 appropriations process, notwithstanding Representative Hoyer’s efforts to move the process along.

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Reading the Tea Leaves Prior to the CJ

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Sharpless Appointed Acting Commissioner of FDA