FY 19 -- Off to a Great Start

Ladd and I have spent countless multi-meeting days on Capitol Hill (often with Alliance members) talking about FDA and its resource needs. At the end of such days, the Alliance has six to eight impressions of how FDA is perceived and whether things are going well for the agency’s cause. It’s a small sample, so you can never be quite sure that you have the full picture.Advocacy Days are different. We had eight teams spread through the House, the Senate, and the Capitol and they had meetings with 60 different offices. With so many impressions -- all taken the same day -- it is possible to draw conclusions with some confidence.One thing we kept hearing was how pleased Congress is with Dr. Gottlieb. We found this in both Republican and Democratic offices. Many of staffers reported that their Member had met the Commissioner at hearings, briefings, visits, and in-district events. Their bosses find him responsive and thoughtful. The goodwill he is generating for the agency is incalculable.Compared to past years, we found many more offices to be well-informed about the agency. There were still many staffers who needed FDA 101, but they seemed eager to learn. We heard more than a few comments about the importance of FDA and how staffers had been surprised to learn about the breadth of the agency’s responsibilities and the number of issues it must resolve every day.While general knowledge about FDA seemed high, most offices had not yet heard about the President’s request for FY 19 or the large increases being proposed for the agency. Our message about these initiatives was:

• The President’s FY 19 request recognizes that there are multiple opportunities for FDA to be a more effective protector of the public health, as well as a fairer and more efficient regulator. We are at a point where additional investment in FDA will result in substantial added value to the American public.

When we reviewed the specific initiatives in the President’s request, we found there was interest and support, but also a lot of questions. In some instances, the rationale for the initiatives required a lot of understanding of how FDA works and the science behind proving safety and efficacy. We learned a lot about which initiatives need more context and we gained understanding of how to explain them to the many staffers who do not already have a deep knowledge of FDA and biomedicine. The Alliance has some educating to do about the specifics and value of the initiatives, but the feedback so far has been excellent.The Alliance “ask” includes additional monies for food safety that are not in the President’s request. Similar to the case with medical products, we found a lot of staff interest and a great eagerness to learn.To summarize: we found that FDA is held in high regard by Members of Congress and there is genuine willingness among both Republicans and Democrats to consider new initiatives that would require funding increases for the agency.But we can’t assume that this will be enough to  win the day. We still expect it will be a hard fight -- dollars to pay for FDA increases are going to be scarce -- but we couldn’t hope to start from a better position.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.