Success ... But More Work Will Be Needed!

Another highly successful Hill Day is in the books. Our timing was near-perfect; Hill staff were back from recess, but not yet overwhelmed. So, with more than 50 Alliance members, we were able to complete more than 60 meetings with appropriators and authorizers. We give a special thanks to everyone who participated.In part due to the Alliance’s effort over the years, we are finding that a growing percentage of Hill staff have an understanding of FDA. Recognition of the agency’s broad mission and growing responsibilities has never been higher. This is very good.Not so good for FDA: the Hill has not yet translated the “skinny budget” proposal for new medical product user fees into a realization that the President’s full budget will likely propose a 37% offsetting cut in budget authority (BA) appropriations. This produces a “paper savings” of approximately $1 bilion, which is undoubtedly what attracted OMB to this approach. Few staffers had previously experienced this particular type of budget gamesmanship.Once explained, one staffer likened it to a shell game. Another suggested we emphasize that it is a “fake swap,” since the new user fees will not pass, but the proposed cuts might still be considered by Congress. Getting Congressional offices to recognize this threat to FDA was a major accomplishment of Hill Day.FDA’s need for the resources (dollars and personnel) requires the current appropriations. More could be justified. Our arguments fell into three categories:

• Incredibly Important Mission: FDA’s mission (safe foods, safe and effective medical products) is a core function of government that benefits every American every day. State and local agencies do not (indeed, cannot) do what FDA does; nor can private organizations or individual consumers duplicate what the agency does. FDA uses a relatively small budget and staffing level to stimulate innovation and provide maximum public and individual benefit.
• Favorable Cost-Benefit: With FDA carrying out its core functions, the medical products and food industries overseen by the agency have become world leaders, job creators, and contributors to a positive balance of trade. When there is a breakdown in FDA oversight: food and medical products that aren’t safe result in death, disability, and severe economic losses. Without a level playing field and industry-wide standards and enforcement, incentives for discovery and innovation disappear.
• Well-Trained FDA Staff Are Indispensable: The public does not have the needed training or tools to assess whether cantaloupe is contaminated with listeria or a statin is reducing cholesterol. The essential services provided by FDA require science-based decision-making derived from specialized expertise and a well-trained, up-to-date staff. More than 80% of FDA’s budget supports employee costs, so the budget can’t be cut without compromising the staff needed to do the agency’s job.

In sum, Alliance Hill Day was remarkably positive. We increased understanding about the budget threat to FDA and why the public health and regulatory missions of the agency require continued high-level support through the appropriations process. Lots more work is going to be needed -- especially after the President’s full budget proposal is released -- but the challenge to FDA is sufficiently great that we know Alliance members will come forward in ever-increasing numbers to articulate support for FDA.