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Honest assessment of priorities: a Congressional imperative for FDA

August 13, 2012

With Congress out of town, this is the first of what will be five “quiet” weeks in Washington. Congress returns about September 10.

But quiet doesn’t mean that things aren’t also quite busy. The executive branch is “in session” every day. FDA is certainly an example — I have even written in another forum on how August used to be a sleepy month in DC, but that we are definitely a 12-month town now. If anything, the executive branch is more visible during Congressional recesses.

Just to take a sample from some of the trade publications I read, FDA is working on: drug surveillance, biosimilars, implementation of the Food Safety Modernization Act, drug track and trace, nanotechnology policy, drug shortages, stem cells, standards for device reviews, and implementation of the new user fee reauthorization legislation.

Of course, there is never a day off in working on the safety and/or efficacy evaluation of drugs, devices, animal drugs, radiation devices, cosmetics, and foods. And that burgeoning production, manufacture and shipping that we collectively refer to as “globalization” — it never takes a holiday.

The size, variety, and growth rate of FDA responsibilities is staggering. While new Congressional directives form one basis, it is far from being the primary source. FDA does more each year because: the number of companies and products keep increasing; the sources of products, ingredients, research, and clinical trials has become global; the complexity of science that underlies FDA-regulated products is exploding; and the public demand for safe food, drugs, devices, and other products is increasing.

The forces that drive growth at FDA are legitimate ones and no Congress can “command the tide to retreat.” If anything, at least on the authorizing side, Congress continues to see more things that FDA should be doing, not fewer. This is why FDA needs to have the resources to do the job that the American public and Congress expect of them. Level funding, even for one year, is a burden. But if that is the best that is possible in FY 13, the agency can act responsibly to preserve its most important functions and continue to shift resources from lower to higher priorities.

Two years of level funding would be positively harmful to FDA and an 8% cut (via sequestration) would be devastating.

Even without Congress in town, August will also not be a quiet month with regard to the fight over sequestration. Before leaving, Congress passed a law directing the President to report on the specific impact a sequestration would have on government programs. The hope is that this “transparency” will fright/shock Congress and motivate grassroots — providing the political will to make difficult decisions and establish priorities rather than give in to the meat-axe approach of cutting everything equally.

As noted in several publications this week, from a political/institutional standpoint, the big losers are the appropriations committees. It has always been their job to take the available federal budget and determine the priorities among all of the demands for federal monies. Sequestration takes that power away from them. Sequestration prevents the appropriations committees from deciding that federal programs that are growing quickly to meet critical public needs — such as FDA — should receive better funding, while other less valuable programs should be cut or eliminated.

This brings us to one of the Alliance’s key themes: FDA will always do better when Congress is honestly assessing priorities and making choices. If FDA receives the same cut (or even the same raise) as all other federal programs, then Congress and the President have not acknowledged the centrality and importance of FDA to public health and safety, as well as its role in jobs and economic growth.

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

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