Columnist Discusses Impact Of Election On FDA.

In Pharmalot (11/6), columnist Ed Silverman discusses how the outcome of the upcoming election will impact the FDA. Steve Grossman of the Alliance For A Stronger FDA non-profit, says that the FDA is not part of the election campaign dialogue. Grossman says this is a good thing, since "any intelligent discussion requires a long-term perspective and a mastery of detail and nuance, both of which are in short supply during sound bite-oriented politicking." However, he notes that the FDA will ultimately be affected by the election. Silverman asserts that the notion that the FDA "would largely continue on its current path with an Obama re-election is not hard to imagine. ... With Romney in the White House, however, the agency is likely to look and feel quite differently – and have a commish who is willing to 'swing the pendulum' away from an emphasis on safety and take any number of steps to speed approvals, regardless of budget cuts."

 

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What Will The FDA Look Like After The Election? from Pharmalot's Ed Silverman

from Pharmalot by Ed Silverman

Four more years or a few more weeks? Those are the choices in the upcoming election, but how might this affect the FDA? Apart from an occasional reference, the agency is not part of the campaign dialogue, notes Steve Grossman of the Alliance For A Stronger FDA non profit. And in his view, this is a good thing, since “any intelligent discussion requires a long-term perspective and a mastery of detail and nuance, both of which are in short supply during sound bite-oriented politicking. But of course, the FDA will be affected, one way or the other.

“First, is the potential for 8.2 percent federal budget cuts in January. Sequester, as the process is known, will leave FDA with about $320 million less to spend in Fiscal Year 13 than it did in Fiscal Year 12. This includes cuts to taxpayer-funded FDA appropriations, about a $2.5 billion base, and user fee revenue, nearly a $1.4 billion base). If cuts were applied entirely to FDA personnel, the agency would have to cut or furlough about 1,000 people,” he writes on his FDA Matters blog.

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