Here is what Ed has to say:
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 afftected, 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.
“We know that the sequester of FDA funding has consequences: 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. Note that this is the opposite of what everyone – critics included – wants. The precise impact is hard to quantify because FDA will try to prioritize its remaining manpower to avoid immediate disasters and avoid any visible failure to approve life-saving therapies.
“Congress does not want to reduce the federal deficit through a sequester. This view is supported by President Obama and his opponent, Governor Romney. Despite this seeming unanimity, an alternative deficit reduction package would need to deal with entitlement programs and taxes. So, politically, deficit reduction is a mess and sequester may happen,” writes Grossman, who is executive director of the non profit, which includes patient advocacy groups, drugmakers, former goverment officials, law firms, trade groups and consultants (see here).
And what about the commish? Will Margaret Hamburg remain if Obama is re-elected? Will Romney do what former president George W. Bush did and let the agency drift with temporary leadership for months on end? “Historically,” Grossman offers, “change at FDA is affected by the interest level of the President (most Presidents aren’t interested in FDA); a growing or shrinking agency budget; an acting versus a confirmed commish,” and Congress.
Not surprisngly, he offers several scenarios. If Obama remains in the White House, Hamburg is likely to remain as well, at least for the first year, especially if there is no sequester. You can read more about the varying possibilities here, although Grossman notes that “it is only a slight exaggeration to suggest the agency would be set adrift and some panic might set in” if there is a sequester and a long-term acting commish.
“If Governor Romney is elected, then the main drivers of change are likely to be his interest level, how quickly he nominates a new commissioner, how controversial his nominee is, and the federal budget situation,” he writes, adding that his attention is likely to be drawn in many other directions. “The best situation would be a well-known, well-respected, candidate who could win easy confirmation. That person would have the opportunity to make a lot of changes, although there would be notable differences if a new commissioner faces budget cuts.”
Of course, ‘well respected’ means different things to different people. The notion, meanwhile, that the FDA would largely continue on its current path with an Obama re-election is not hard to imagine, at least for the short run. 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. In fact, a Romney commish is likely to boast about a goal of approving more drugs with fewer resources.
Ed's blog is found here
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