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Advocacy at a Glance

April 21, 2018

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.

  • Alliance’s Hill Day on April 25. Please Join Us. We already have more than 50 meetings scheduled and expect more as we get closer to April 25. It is a fun day and makes a real difference for FDA. We provided an FAQ with more details. If you can participate for any part of the day, RSVP by e-mail to Carrie Morgan. If you have questions about participating, please e-mail Steven Grossman.
  • Commissioner Gottlieb Testifies Before House Appropriations Subcommittee; FDA Numbers Adjusted. This past week, Dr. Gottlieb testified for the first time on the FY 19 budget request. His testimony focused on 2017 accomplishments and the opportunities to provide sponsors with disease-specific guidances and with new tools that can increase the reliability and lessen the cost of drug development. During questions, he emphasized the particular importance of the initiative to develop standards, guidance, and policies on continuous manufacturing; the move toward real-time evidence monitoring to strengthen safety and efficacy decisions; and the compelling case to build a knowledge management platform. All of the new initiatives are addressed on pages 14-20 of the FDA’s budget request for FY 19

Any time the current year appropriations are set after the President’s request, there will be discrepancies between the OMB numbers and the numbers used by the Appropriations committees, creating some confusion. The chart in this week’s Analysis and Commentary tries to cut through that to show how the Alliance’s ask (“at least $3.364 billion in BA funding”) was derived.

  • Commissioner Gottlieb to Testify Before Senate Appropriations Committee. Dr. Gottlieb will present FDA’s FY019 budget request at an April 24, 2:30 p.m. hearing of the Senate Subcommittee on Agriculture, Rural Development, FDA and Related Agencies.
  • Alliance Meets with Dr. Ostroff and Directors of CFSAN and CVM. This week, a team of nearly 20 Alliance members and staff met with Dr. Stephen Ostroff, Deputy Commissioner for Foods and Veterinary Medicine, Dr. Susan Mayne, Director, Center for Food Safety and Applied Nutrition, and Dr. Steven Solomon, Director, Center for Veterinary Medicine. One discussion item was the agency’s efforts to enhance their relationship with the states on FSMA implementation, while trying to free up more FDA staff to work on international coordination and inspections. Dr. Ostroff also spoke about the HHS OIG report that was critical of how FDA handled recalls. He said they will streamline and improve the recall processes to be sure food comes off the market. They are also looking at the USDA’s Food Safety and Inspection Service methods for providing recall information at the consumer level. With respect to the recently announced nutrition initiative, resources will be needed to accomplish what is being suggested.  There may be some opportunities through labeling, and a need to work on standards of identity.

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