Our Strength Is in Our Cause

ADVOCACY

Alliance Annual Membership Meeting.

Wednesday, October 27th at 2:00 p.m. Special Guest Speaker, Dr. Lu Borio, FDA, Office of the Commissioner.

ANALYSIS AND COMMENTARY

Two weeks ago, I provided analysis of the federal budget situation, the election and the implications for FDA. It is still worth reading.  A pivotal point was that: “regardless of the outcome of specific races or which party has the most seats, there will be a working majority of Republicans and Democrats in the House and Senate who are committed to deficit reduction.”Cost-cutting movements are already underway in Europe. In France, proposed pension reforms have led to a national strike that threatens to cripple the French economy. In the UK, the recently-announced Comprehensive Spending Review would impose cuts averaging 19% over 4 years across all government departments, with some being asked to cut by as much as 30%.Similarly, Americans are going to have to learn how to do without some programs, tax benefits and entitlements to which we have become accustomed … or at least, so it seems at the moment.In the UK, the reason that some agencies will be cut by 30% is so that others might get increases or at least cuts less than 19%. The same principle will need to be established here. Our Alliance actions are designed to be sure that budget-cutting legislators see FDA as an exception, an agency that needs to expand even as others contract. We hope that other public health service agencies are similarly spared, but our mission is to make the best case and fight hardest for FDA.Even in the abstract, cutting FDA (or even flat funding it) seems like particularly poor policy. The agency responsibilities are growing, every American is affected every day, science is becoming more complex and the products the agency regulates are increasingly global. The pain of no-growth or cuts would be particularly acute at FDA, where more than 80% of the appropriation is spent on personnel and related costs (such as rent). Even a small decrease in the agency’s appropriation could lead to furloughs, buy-outs or lay-offs. The British term for lay-offs is “redundancies.” It is hard to imagine many FDA staff who are redundant!

FDA under pressure (cuts or flat funding) would need to re-establish priorities. There can’t be more food inspections unless there is less of something else. Science-based modernization of the agency is universally applauded, but can the effort be accomplished without taking resources away from other activities? Similarly, no one wants any slackening of safety and efficacy reviews of proposed and marketed medical products, but this requires manpower to accomplish.A lot that we expect FDA to do in the future can’t be accomplished in an environment of budget cuts.  It is possible that legislators might even try to split us apart, hoping that FDA stakeholders might turn on each other and ease the pressure on Congress.Should this occur, we hope that all Alliance members remember Thomas Paine’s admonition to our Founding Fathers -- repeated by Benjamin Franklin at the signing of the Declaration of Independence -- that:  “We must all hang together or we shall most assuredly all hang separately." Our strength is in our cause, but what makes the Alliance effective is our unity.

Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.