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Alliance Still Committed to Protecting FDA from Sequestration

February 8, 2013

In last week’s Analysis and Commentary we began: Who are you going to believe? We juxtaposed all the gloom/inevitability of sequester coming from Members of Congress with a report that defense contractors seem to believe that sequestration will not occur. From their standpoint, predictions of gloom — made one month out — are meaningless indicators of what Congress will do.

And this is exactly how it seems to be playing out. In a form of kabuki theater, with lots of twists and turns, President Obama started on Tuesday with a proposal that could best be described as “Let’s pass some specific cuts (not across the board) on March 1, then defer the bulk of the required savings for a few more months while we find alternatives.” He provided no specific proposal, but informed Congress that they could choose from among a list of acceptable cuts that had previously been offered by the White House.

The House Republicans, true to their role, declared such an approach “dead on arrival.” Sequester, in the view of some them, must occur if there is any chance of changing Washington’s culture of spending. House Speaker John Boehner seemed to agree with this assessment, while at the same time leaving many with the impression that the door was still open for some type of deal.

There are still more plots and subplots. A number of Members of Congress (both parties and both Houses) remain concerned about the sequester’s defense cuts and their possible impact on national security. A smaller, but still significant number of Members — including new Senate chairs Patty Murray (Budget) and Barbara Mikulski (Appropriations) — are equally concerned that the non-defense sequester cuts are too large and damaging to the economy and the social safety net.

What happens to FDA if sequester cuts are imposed on March 1? Commissioner Hamburg provided her own answer — as described in the three attached press stories on her remarks at the Alliance quarterly meeting (see today’s Advocacy at a Glance). However, neither FDA nor OMB will release an official list, for fear of providing Congress with ideas for future cuts.

Despite the lack of a list, significant programmatic and manpower reductions would be inevitable under sequestration. If cuts occur in FDA funding:

  • Food will be less safe and consumers may die,
  • Drug and device approvals will be slower, conflicting with promises made to consumers and companies,
  • Problems with imports and globalization will become more numerous, and
  • Three new laws (involving food safety, drug and device safety and efficacy and biosimilars) will be slowed in their implementation and many programs to modernize FDA process will be halted.

These four bullets fully explain why the Alliance is committed to protecting FDA from sequestration.

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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