The Good Start Continues ... Let's Show Appreciation

In a prior column -- written just after the Alliance’s Hill Advocacy Day -- I observed that we were off to a very good start, but that nothing should be taken for granted. The House subcommittee mark-up affirms the good start, but doesn’t reduce the need for us to be active and persuasive advocates for FDA funding. Here are some Q&A to help clarify where we are.Q. What is the main objective of our efforts this year and does the House bill fulfil it?A. We are seeking FY 19 FDA funding that recognizes there are “multiple opportunities for FDA to enhance its role as a protector of the public health, while becoming a more thorough and efficient regulator. We are at a point where additional investment in FDA will result in substantial added value to the American public.” While we lack some details, it is clear that the House funding proposals embody the same vision of what can be achieved by additional funding of FDA.Q. Which House Members should we thank for their support of FDA?A.  The list of subcommittee Members is here and their Twitter handles are here. All deserve our thanks for their support of the FDA. In particular, it would be helpful for Chairman Aderholt and Ranking Member Bishop to hear from the FDA stakeholder community.Q. Could the favorable House subcommittee mark change at full committee?A. Subcommittee funding levels are likely to be adopted “as is.” However, there is no guarantee of this and changes have occurred in the past -- both before and during the full committee mark-up. This reflects issues not resolved at the subcommittee level, as well as issues raised by full committee Members who are not on the subcommittee.Q. What are the key details about the subcommittee bill that we won’t know about until the Committee Report becomes available?A. We are pleased by what we know: the aggregate increase in BA funding ($300+ million) and specific funding for opioids, advanced manufacturing, generics, and the Oncology Center of Excellence. Until the Committee Report is available, we are unlikely to know how much each Center is going to receive or the allocations to specific programs and initiatives within the aggregate increase. We are especially interested in whether all of the President’s proposed initiatives are being funded and whether the monies are intended as the first-year cost (rather than the total cost) of implementing those initiatives.Q. What did the Alliance ask for that is not in the subcommittee bill?A. The subcommittee’s funding proposals -- an aggregate increase of more than $300 million (10%) -- are a huge step forward in deepening public investment in FDA. Admittedly, our “ask” was larger, but we want to make sure that the House receives the credit it deserves for making such a major commitment to the agency. Beyond that, we are concerned about the apparent lack of additional investment in food safety programs.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.