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Advocacy at a Glance

March 29, 2019

Commissioner Gottlieb Testifies Before the Senate Ag/FDA Appropriations Subcommittee. The Senate Ag/FDA Appropriations Subcommittee held a hearing on Thursday, March 28, to review the FY 20 budget request for the Food and Drug Administration. Members were complimentary of Commissioner Gottlieb and clearly positive about the FDA’s vital work and the need for the agency to be well-funded. The video of the hearing (about an hour) can be found here. Chairman Hoeven’s opening statement can be found here. While Commissioner Gottlieb’s opening statement — as presented — focused on opioids, his prepared remarks described FDA’s actual budget request and can be found here. Questions were primarily on opioids, dairy standards of identity, Farm Bill provisions related to hemp and the regulation of CBDs, the USDA-FDA agreement regarding the regulation of cell-based meat, and prescription drug pricing. This week’s Analysis and Commentary looks at the evolution of Congressional attitudes toward FDA.

Commissioner Gottlieb to Testify Before the House Ag/FDA Appropriations Subcommittee on April 3. The hearing will be at 9:00 a.m. on Wednesday, April 3. It will be held in Rayburn 2362-A, where the subcommittee has held past hearings.

House Appropriations Committee Sets April 5 Deadline for Public Witness Testimony for the Record; Senate Sets April 12. Every year, there is an opportunity for public (non-governmental) organizations to submit testimony for the Appropriations Committee record. This year, the House 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. Information for Senate submissions (by April 12) is here. If you need additional information or assistance in preparing testimony for either the House or Senate, contact Roger Szemraj.

FDA Reorganization to Start March 31. Just in time for Acting FDA Commissioner Ned Sharpless to take over, Dr. Gottlieb has gotten approval for his reorganization plans. The key change is that the center directors will formally report directly to the Commissioner rather than through deputy commissioners. There were a number of other changes, many important, as reported here.

Alliance to Host FDA Deputy Commissioner for Policy on April 10. Alliance members and media are invited to our upcoming meeting with Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis at FDA. The event is on Wednesday, April 10 from 2:00 to 3:00 p.m. and will be at a convenient downtown DC location. Her remarks should provide valuable insight into FDA’s priorities for the rest of FY 19 and for FY 20. To RSVP, click here.

Senate Also on Accelerated Schedule to Pass Appropriations Bills.  As reported by Research!America (a long-time Alliance member), a key Senate staffer has told them the goal is for the Senate to complete mark-ups on all Appropriations bills before July 4. Previously, we had reported the House’s goal to pass all Appropriations bills by the end of June, an even faster pace. While it’s hard to imagine either body fully meeting those goals, it strongly suggests that bills are going to be formulated and moved earlier and faster than in recent years. The Senate staffer also confirmed that the Senate is considering pairing bills together (e.g., DOD and L-HHS), as was done successfully in FY 19. The House also is thinking along these lines (see here).

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