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“There is No Secret Pre-election Budget Deal”

October 26, 2012

This week, Hill staff confirmed what we suspected: there is no secret pre-election budget deal. What will be possible post-election is totally unknowable. Even where Members are working on plans to deal with the sequester and the fiscal cliff — no one could tell us whether these negotiations are close to something workable or very far away. Ultimately, finding the needed savings is difficult but not impossible (e.g. Simpson-Bowles). It is the politics of compromise that are the true unknown.

In this environment, our goal is to lay out the case for why FDA needs special consideration, to explain why the impact of sequestration on the agency will be deleterious to the health and well-being of all Americans. There is no easy “catchphrase” to explain FDA and its reach (as compared with air traffic controllers saying that that sequestration may well create “flightless Friday’s.”) Similarly, there is no simple factoid that encapsulates the actions FDA will have to take to live within a budget reduced by 8.2%.

However, over the years, we have come up with our own ways to explain FDA’s importance — and this is a process that continues to evolve. We always mention the breadth of the agency’s jurisdiction:  oversight of about $2 trillion in goods and services and nearly one-fourth of all consumer spending in the United States. We always get a laugh from staffers when we ask them to envision a coalition like ours advocating for any other federal regulatory agency (e.g., the Securities and Exchange Commission). FDA must be playing a totally different, far more vital role, if patients, consumers, industry and other stakeholders all want a well-funded regulator.

Those points made, we then turn to the specifics.  FDA would lose $319 million (8.2%) in a sequester. If all the savings were achieved through lay-offs, it would mean more than 1,000 fewer people would be protecting the public health and advancing medical innovation.  The result would be:

  • Food will be less safe,
  • Drug and device approvals will be slower,
  • Problems with imports and globalization will become more numerous, and
  • FDA modernization will be severely slowed.

Meantime, the responsibilities and pressures on the agency continue to grow exponentially. In the face of sequester, we focused on the impact of new laws and mandates. While many federal programs have not been recently or thoroughly re-evaluated, FDA has. In 2010, Congress reviewed the FDA’s food safety programs. This year it looked at the agency’s drug and device programs. While Congress thinks there is much that needs to be done at FDA to achieve better results — both laws are clear affirmations of Congress’ interest in sustaining and expanding what FDA does.

Unfortunately, sequester cuts would take the BA (taxpayer) portion of FDA funding below FY 10 levels; that is, before FSMA, FDASIA, and assorted program/inspection upgrades. The user fee cuts further undermine these new laws. FDA (of necessity) will shift its focus to preventing disasters (external) and maintaining basic functions (internal). There cannot possibly be monies for the robust implementation that Congress intended when it passed these new laws.

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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