FDA Matters has been wondering: when is the right time to start talking about the 2012 U.S. Presidential election and how it might affect FDA’s future? The best answer is: when Congress has finished its FDA policy work for the year. With the enactment of FDA user fee reauthorization legislation and a pending agreement on government funding for the first half of FY 2013 (starts October 1, 2012), it is now time to start talking.
Without picking sides: what issues face FDA after the election and in 2013? How might the agency be affected by whether President Barack Obama is given another four year term or challenger Mitt Romney is elected President?
For those of us deeply involved in the FDA world, the most important difference between the candidates might well be their approach to the agency and particularly toward FDA leadership.
President Obama has not yet issued any statements about FDA on his campaign website. However, based on the last 3 ½ years, he supports FDA and its mission and sees that the agency’s role is likely to continue to grow because of globalization, public health and safety, and the need to encourage innovation.
His overall regulatory positioning might be considered less favorable to FDA. New agency regulations must pass through the Office of Management and Budget (OMB)’s Office of Information and Regulatory Affairs (OIRA). Cass Sunstein, a distinguished legal scholar appointed to head OIRA in 2009, is considered to be more open to de-regulatory approaches that may be inconsistent with FDA’s growing responsibilities. For example, it is his office that is currently holding up some of the regulations needed to implement the Food Safety Modernization Act.
The Republic nominee, Mitt Romney, has not yet issued any specific policy statements on FDA. However, he appeared at a medical device company event in late March and suggested that FDA is part of an “attack on free enterprise” by “the thousands upon thousands of bureaucrats that work in Washington.”
His campaign website does not reference FDA, but it does have a position paper on regulation. In it, he advocates:
· Imposing a regulatory cap of zero dollars on all federal agencies*
· Requiring congressional approval of all new “major” regulations
One should never take campaign speeches too seriously. Even allowing for that, it would appear there are significant differences in how the two candidates view FDA today. These differences may narrow or expand in the three months until Election Day.
Just as the two candidates appear to differ strongly on the role of FDA, they are also likely to differ on their choice of FDA commissioners. This is not just a matter of whether Romney wins, but also if Commissioner Hamburg is thinking about leaving (and we have no knowledge of this, only that it is not uncommon for Administration leaders to leave in the year after a President is re-elected).
The history of appointments of FDA commissioners is quite varied, starting with 1991 when Dr. David Kessler became the first Commissioner to face a Senate confirmation hearing. He resigned at the beginning of Clinton’s second term (analogous to an Obama victory and a decision by Dr. Hamburg to leave). It took nearly two years for President Clinton to appoint his successor and the Senate to confirm the appointment.
Hiring a new commissioner was not a priority for the new Bush Administration in 2001. Dr. Mark McClellan was confirmed in November 2002, more than 20 months after the new Administration took office. In contrast, Dr. Hamburg was appointed by the Obama Administration and was confirmed by May, a delay of less than 5 months.
So, if Romney wins or Obama wins/Hamburg resigns….we may have a new Commissioner quickly or the job may be vacant for a long time.
Overall, the differences between Barack Obama and Mitt Romney are likely to matter a great deal to FDA. In turn, this will affect FDA stakeholders….regardless of their politics or their views on whether FDA needs continuous improvement or an outright overhaul.
Steven
* My understanding of this: the private sector cost impact of any new federal regulation must be offset by the private sector savings from repealing or significantly revising an existing federal regulation.
P.S. For those wanting more on FDA and the U.S. elections, FDA Matters intends to write often on this topic over the next few months.
From CQ Roll Call Daily Briefing of August 3, 2012:
CASS-BENEFIT ANALYSIS: Presidential regulatory czar Cass Sunstein is resigning at the end of the month and returning to Harvard Law School, the White House announced this morning. Sunstein, who runs the Office of Information and Regulatory Affairs — the arm of OMB that is enormously powerful because it gets to say thumbs up or thumbs down on every new regulation proposed by a department or agency — has been one of the business-friendlier people in positions of true influence in the administration.
That’s because he was a champion of using cost-benefit analyses to assess the propriety of federal regulations, which corporate America thinks generally works to its benefit. Liberals activists, in turn, were extremely frustrated that the administration did not take a more aggressive approach to regulatory policy — especially at a time when so many policy shifts they sought were stymied in Congress. Sunstein’s signature achievement was a comprehensive review of all federal regulations already on the books with an eye toward streamlining or elimination — which the administration says has produced more than $10 billion in five-year savings and a paperwork-reduction burden on businesses measurable in the millions of hours annually. “With these reforms and his tenacious promotion of cost-benefit analysis, his efforts will benefit Americans for years to come.” Obama said in a statement. (The two taught together and became friends at the University of Chicago law school, where Sunstein promoted the theory of “behavioral economics” — the notion that human behavior doesn’t always jibe with traditional economic models.)