Notes from the Alliance’s Meeting with CBER Director Peter Marks and more
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.
Support FDA by Participating in the Alliance’s Hill Day on April 25. The Alliance meets with Congress year-round, but we also set aside at least one day per year devoted to educating Hill staffers about the FDA and its resource needs. Hill Day is April 25 this year. We already have about 50 meetings scheduled and expect more as we get closer to April 25. It is an important opportunity to be heard and it does make a difference for FDA. Last week, we provided an FAQ with more details. If you can participate, please e-mail Carrie Morgan to let her know.
Commissioner Gottlieb to Testify Before House Appropriations Committee. Dr. Gottlieb will present FDA's FY 2019 budget request at an April 17, 1:30 p.m. hearing of the House Subcommittee on Agriculture, Rural Development, FDA and Related Agencies. The hearing will be in 2362-A Rayburn.
Release of Detailed FY 19 Budget Provides More Insight, Revised “Ask”. The President’s detailed budget request has been released. Based on that, we have made a couple of tweaks to our “ask,” as reflected in the testimony we are submitting to the House today. We are requesting at least $3.364 billion in FY 19, including the President’s request for $432 million in additional spending, primarily on medical products programs and at least $50 million more than the FY 18 appropriated levels for food safety programs. This total would also include appropriating $70 million for the already-paid-for funding of the 21st Century Cures legislation. Note that this is sufficiently close to our previous “ask” that there is no need to revise past documents. However, we urge members to use these numbers in subsequent discussions with the Hill.
Notes from the Alliance’s Meeting with CBER Director Peter Marks. This week, a team of nearly 20 Alliance members and staff met with Dr. Peter Marks, director of FDA’s Center on Biologics Evaluation and Research. Among other things, he highlighted several applied scientific and regulatory initiatives that he hopes to advance with monies in the FY 19 budget. Along with prior meetings with CDRH (Shuren) and CDER (Woodcock), we are seeing an FDA that is poised for great things, but needing the resources to get there. Dr. Marks' remarks are covered in more detail in this week’s Analysis and Commentary.