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.

• President’s Budget Blueprint Puts FDA at Risk. This week’s Analysis and Commentary goes behind the headlines to explain why the President’s proposal to dramatically increase medical product user fees threatens FDA’s ability to fulfill its mandate and responsibilities. Beyond the proposed increase in user fees being neither wise nor realistic, there is a dynamic being created that potentially puts hundreds of millions of dollars of FDA’s budget authority (BA) appropriations at risk. While this week’s column is a bit longer and more detailed than the usual, it explains the challenges to FDA funding that are embedded in the way the appropriations process works. We urge you to give it your attention.

• FDA Testifies at User Fee Hearings on Capitol Hill; Says Nothing on President’s Blueprint Proposal. OMB has issued directions to federal agencies that their appropriations committee testimony and other external communications should not include any information about the full budget request that the President will submit to Congress in May. The implication, as well, was that agencies should not elaborate on items in the budget blueprint released last week.  FDA testified at both House and Senate user fees hearing this week, but did not stray from this policy. Here is Dr. Woodcock’s testimony on the House side. As reported by The Pink Sheet, there appears to be progress on FDA hiring despite the freeze imposed by the President. Specifically, slots related to 21st Century Cures and some user fee slots are not being constrained, although details are not available.

• 21st Century Cures Act Tracker Launched by FasterCures. As Congress’ latest statement on improving and modernizing FDA, implementation of the 21st Century Cures Act will be a major focus of agency activity going forward. To keep pace with this and provide a resource for the FDA community, FasterCures has developed a tracking site that will be updated regularly.

• Senate Commits to Speedy Passage of User Fee Legislation; Will Not Allow Unrelated Amendments or Ones that Are Not Bipartisan.  As reported by Inside Health Policy, Senate HELP Committee Chairman Alexander has announced his intentions to move user fee reauthorization legislation forward to meet a July deadline that would avoid the issuance of lay-off notices to FDA employees funded by user fees. Anticipating that the user fee legislation will draw other FDA-related amendments (as it has in the past), he indicated that the committee would only consider adding provisions that are bi-partisan and non-controversial.