How will the US election affect the FDA?

Steven Grossman

FDA Matters

Steven Grossman, policy and regulatory consultant and author of the blog FDA Matters, discusses the upcoming US election between President Obama and Mitt Romney, and how the election results will affect the FDA.

While FDA issues have hardly disappeared from the policy / regulatory arena, the agency has been largely invisible during the political campaign leading up to the November 6 U.S. elections. Not only is the Presidency at stake in the election, but also 33 Senate seats (1/3 of the body) and all 435 House seats1.

Yet, the FDA will be strongly impacted by the election’s outcomes. I have focused my immediate thoughts on FDA’s budget and on the prospects for changes at FDA. Critical to any such consideration is that FDA is people-driven — more than 80% of the agency’s budget is devoted to keeping its staff productive and effective and, of course, the election will determine which party (and perhaps which specific person) will run the agency for the next four years.

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“…the FDA will be strongly impacted by the election’s outcomes.”

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FDA funding at risk, now and for the future

The new Congress won’t start until early January and the President won’t take the oath of office until later that month, but the election’s impact on FDA will start almost immediately. Congress plans a post-election session (includes those defeated and retiring, not the newly elected Members) and there are urgent budgetary, tax and fiscal issues that need to be addressed.

The most pressing issue for FDA will be what happens with sequestration, an 8.2% across-the-board budget cut that will hit most federal agencies on January 2, 2013. Absent some action to repeal, defer or replace sequestration, FDA’s budget will be cut about $320 million — of which about $205 million will come from taxpayer-supported FDA programs and about $115 million from industry-user fee programs. While some of the money will come from overhead items, the pinch on personnel is unavoidable. Were the entire cut to come from staffing, FDA would have to lay-off or furlough about 1000 employees.

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“…pressure on federal spending will continue far beyond the immediate future.”

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Neither Congress nor either of the Presidential candidates wants the sequester to occur, but it cannot be separated from larger, politically charged issues involving reducing the annual U.S. federal deficit. The election may clarify these issues, pointing a way for resolution. However, it is more likely that Congress will find a way to delay the sequestration to the newly-elected Congress or, possibly, that the cuts will actually occur.

Even if sequester were somehow to be avoided, pressure on federal spending will continue far beyond the immediate future. Sequester is the most immediate hurdle in what is likely to be an annual challenge to all federal agencies, including (and especially) FDA.

The Alliance for a Stronger FDA, the leading advocacy group for increasing FDA resources, is anticipating just such an eventually — and has emphasized the need for Congress to return to allocating funds on the basis of national priorities. They argue that FDA can compete successfully for scarce dollars, assuming that the situation is not pre-determined by across-the-board cuts.

Drivers of change, post-election

No matter who wins the election, FDA’s key (and most visible) responsibilities remain the same:

• Assure the safety of food, drugs, devices and other products it regulates,

• Provide a scientifically-rigorous, as well as reasonable and responsible, pathway for pre-market review of drugs and devices.

Further, government does not have the will (nor in many cases, the power) to reduce FDA’s burgeoning workload. Increased demands on FDA come primarily from globalization, scientific complexity and new legislative and regulatory mandates in food safety, drugs and devices. On this last point, Congress has recently re-affirmed the need for a strong FDA presence in food (2011’s Food Safety Modernization Act) and drugs and devices (2012’s FDA Safety and Innovation Act).

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“Further, government does not have the will (nor in many cases, the power) to reduce FDA’s burgeoning workload.”

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However, this is hardly an argument that elections don’t matter. Change at FDA is heavily affected by: the interest level of the President, whether the agency budget is growing or shrinking, whether the commissioner is acting or confirmed, and how activist a role Congress wants to take. The election will determine most of these for the next two to four years.

Below are two charts that look at what might happen if President Obama is re-elected or if Governor Romney is elected as President. They focus on the opportunities for change at FDA and reflect the primacy of: who is the commissioner, how difficult it will be to gain Senate confirmation (only current FDA Commissioner Hamburg would not need confirmation), and whether budget cuts force the agency to retrench. A potentially protracted fight over Senate confirmation of a new FDA commissioner is always a possibility.

If President Obama is re-elected… then the two main drivers of change are likely to be whether Commissioner Hamburg decides to stay and the federal budget situation.

figure-1-obama-elected-fda-changes

If Governor Romney is elected… then the main drivers of change are likely to be how quickly he nominates a new commissioner and whether that individual is a well-known, well-respected, candidate who could win easy confirmation. A worst case for FDA would be a repeat of 12 years ago, when it took 18 months before a commissioner was in place.

figure-2-mitt-romney-elected-fda-changes

Timeframes

The budget analysis and Obama / Romney “change” charts provide a compressed overview of events that will occur over a period of months. The presidency and control of the Senate should be decided within a day or two of the election. However, budget cuts won’t be finally decided until later this year or may be delayed into next year.

Whether Dr. Hamburg stays will be both her decision and that of President Obama. That might be announced quickly or not. If there is to be a Romney Administration, it is likely to be at least March 2013 (probably later) before a nominee is announced.

References

1. Not being part of the campaign dialogue is probably a good thing for FDA. Any productive consideration of FDA’s future should include a long-term view of its history and needs, as well as a grasp of the nuances of how it functions and who it serves. None of this fits well into a political campaign, where “pithy” and “easily grasped” are the goals.

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About the author:

Steven A. Grossman is president of HPS Group, LLC (www.hpsgroup.com), a strategic public affairs and regulatory consulting firm located in Silver Spring, MD. As part of his consulting practice, he is the author and publisher of the blog, FDA Matters (www.fdamatters.com). He is also Deputy Executive Director of the Alliance for a Stronger FDA, a 200-member multi-stakeholder advocacy group that supports increased appropriated funding for the FDA (www.StrengthenFDA.org)

Earlier in his career, Mr. Grossman was a Deputy Assistant Secretary for Health at DHHS and Health Staff Director and Majority Counsel to the Senate Committee on Labor and Human Resources (now Senate HELP Committee). He was one of the chief Senate negotiators on the Orphan Drug Act of 1983 and on the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman).

How will the FDA be affected by the upcoming US election?

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