New FDA Commissioner Scott Gottlieb
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 Looks Forward to Working with New FDA Commissioner Scott Gottlieb; Dr. Gottlieb Sees “a Clear and Historic Opportunity” to Advance FDA’s Mission. In an all-hands address to FDA staff on May 15, newly-confirmed FDA Commissioner Scott Gottlieb set out his immediate priorities, stressing the importance of science-based decision-making generated by professional staff. For his full remarks please click here.
Secretary Tom Price Pushes “New User Fees Replacing BA Spending” Budget Proposal; Congress Not So Interested. In the skinny budget, President Trump proposed a billion dollars more in new medical product user fees as a way to reduce budget authority (BA) appropriations for FDA by a similar amount. The Alliance has spoken out against this proposal on both philosophic grounds (FDA’s core funding should come from taxpayers, not industry) and practical grounds (the current reauthorization of user fees will not be re-opened).
This week, HHS Secretary Price sent letters to key authorizers asking them to adopt the Administration’s expanded user fee approach. There was an immediate negative reaction from Capitol Hill. The response of Senate HELP Chairman Lamar Alexander is available here; the response of HELP Ranking Patty Murray is here. The appropriations committees have also expressed some reservations by adopting section 716 of the FY 17 funding bill (discussed here), which would affect any proposed new medical product or food safety user fees.
Detailed FY 18 Budget on Tuesday. OMB will issue its detailed budget on Tuesday – we expect the President to propose to make significant cuts to FDA appropriations and replace the funding with new user-fee proposals, as outlined in the previously announced “skinny budget” and further described by Secretary Price this week.
Important Note to FDA Stakeholders and Media: Don’t be Misled by Detailed Budget on Tuesday. No matter what is actually in the President request, we know that everyone’s first impressions will be shaped by OMB’s typical rosy interpretation of what is being proposed. The Alliance’s goal—reflected in this week’s Analysis and Commentary -- is to reduce confusion (and inspire more accurate media coverage) by explaining in advance the several ways in which the Administration’s headline numbers are likely to be misleading.
Commissioner Gottlieb Plans to Testify in Front of House Agriculture Appropriations Sub-Committee on Thursday. Commissioner Gottlieb will then testify next week Thursday at 10 a.m. in front of the House Appropriations Agriculture-FDA Subcommittee regarding the FY 18 budget request. While the Alliance does not support the concept of reducing appropriations and replacing them with new user fees, it is important to note that FDA may be one of the few federal agencies where OMB recognizes that the existing level of funding needs to continue – regardless of source.