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Janus, Ambiguity, Uncertainty, But Real Determination

January 21, 2011

LEGISLATIVE DEVELOPMENTS

The Democratic members of the House Agriculture Appropriations subcommittee were named this past week:

  • Sam Farr (D-CA), Ranking Member
  • Rosa DeLauro (D-CT)
  • Sanford Bishop (D-GA)
  • Marcy Kaptur (D-OH)

ANALYSIS AND COMMENTARY

A key to running a successful business is to create certainty in your environment. It is why FDA-regulated industries are always pressing FDA for better-defined rules and procedures. The unexpected is planned for, but rarely desired and often accepted reluctantly.

In contrast, politics and policy-making requires a tolerance for ambiguity. There is rarely any certainty. Alliances shift. Majorities change. Political priorities evolve. A legislative pathway opens, then closes suddenly. Last year’s two FDA-relevant legislative enactments — biosimilars and food safety — could be case studies in the twists and turns of the process.

That said, 2011 is likely to require more tolerance for ambiguity on our parts than in most years. Despite the potential for sweeping budget cuts, FDA may survive intact, maybe even receive an increase. Or it may be dragged down in an environment where returning to FY 08 levels is being discussed for this year and returning to FY 06 levels is being proposed for FY 12 and beyond.

The Senate may be a bulwark against House activism. Or not. Whether based on past campaign promises or viewing their election prospects for 2012, there may be a number of Democratic Senators willing to join Republicans on some sweeping deficit reduction proposals.

The President’s veto pen may “protect” the Congress from its own potential excesses. Or not. There are a number of limitations, particularly that he can’t veto everything. For example, the President can delay but not prevent a government default if the debt limit is not increased by Congress. He will sign legislation this year that contains provisions with which he does not agree. But which bills, which provisions? Further, we can expect the President to come out with his own “tough on the budget deficit” position at next week’s State of the Union.

For FDA’s resource needs, the possibilities are extreme. There could be a rapid change in the  larger concept of government’s role and appropriate funding levels (as occurred in 1981). If so, then FDA will have to re-assess its mission and re-think its priorities. It would be a different FDA in a dramatically different federal government. The opposite could happen: the political process works out compromises. Change comes more slowly and less dramatically. The FDA could be protected, perhaps based on the same rationale that will probably protect homeland security programs.

For the Alliance for a Stronger FDA, this means planning for a larger range of possible scenarios. We will need to react rapidly as the situation changes, as might occur almost daily. We will need to reach appropriators, authorizers and new members of Congress with our message that FDA has large and essential public health responsibilities and not nearly enough money. Job creation and homeland security are likely to be key themes for this year and we will be showing how FDA is a positive force in both.

The Alliance will need the broadest possible support from our members. This is the proverbial “where the tire hits the road” for FDA. We have no choice but to succeed on FDA’s behalf in this fluid and difficult year.

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

RELEVANT MEDIA

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