Should the FDA Have an Independence Day?

Years ago, while helping an incoming administration evaluate the public health service agencies at HHS, I became captivated by the idea that a series of reorganizations would solve many of the problems. I eventually snapped out of my trance and learned a life-long lesson: redrawing organizational boxes and altering reporting relationships are rarely effective solutions.

FDA Matters thinks that making FDA an independent agency will not make FDA more effective or more efficient. Although the idea is not truly harmful, proposing independent agency status is a seductive distraction from the tough job of improving FDA.

Making FDA an independent agency has been proposed many times before. The issue has come up now because Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), included it last week among a number of proposals in his “state of the industry” speech. The industry is to be applauded for its commitment to new thinking, which focuses on ways to stimulate investment in biosciences, as well as improve FDA. While I think there may be some great ideas in BIO’s proposals, an independent FDA is not one of them.

An” independent agency” is a federal government organization that is not located within one of the 15 executive departments.  While most independent agencies are commission-type organizations run by a board, some are structured in a manner similar to the executive departments.  Examples include the Environmental Protection Agency (EPA), the National Aeronautics and Space Administration (NASA), and the National Science Foundation (NSF).

Being independent sounds great, but would it really help FDA become a more effective or better-resourced agency?

Independent agencies do not run independently of the President and the Executive Branch. Whether part of HHS or independent, FDA’s authority derives from the President, its money comes through the Office of Management and Budget (OMB), its manpower is cleared by the Office of Personnel Management (OPM), and its office space and purchases are controlled by the General Services Administration (GSA).

The chief advantage to FDA of being independent would be the ability to by-pass HHS leadership and bureaucracy. While HHS may be a problem, does anyone want to argue that it is so bad that it requires FDA to be uprooted? Historically, it is OMB that has pushed FDA budget requests downward and objected to FDA regulations. That wouldn’t change.

Being an independent agency does not necessarily improve access to the President. Because only heads of executive departments are cabinet members, the HHS secretary currently speaks for FDA when the cabinet meets.  The head of EPA has the status of “cabinet-rank,” along with OMB. I am not sure whether EPA gets much out of this honor, but similar standing for FDA would seem unlikely.

Being an independent agency does not move an organization to a different appropriations committee. EPA is funded by the Interior, Environment and Related Agencies subcommittee. NASA and NSF are funded by the Commerce, Justice, Science and Related Agencies subcommittee. Independent or not, FDA will be funded as part of the Agriculture appropriations bill.

Independent agencies haven’t necessarily prospered, either. NASA had a good track record while it embodied a national aspiration, but it is clearly on the decline now. The National Science Foundation has never enjoyed the level of support given the National Institutes of Health.

That leaves us, perhaps, EPA as the embodiment of an independent agency with regulatory and scientific responsibilities. Has science triumphed at the agency because its independent status shields it from politics? It seems unlikely that anyone would make that argument. EPA, too, appears to be an agency on the decline.

Maybe FDA would benefit from being an independent agency, although I don’t think so. At best, it would take enormous political effort to accomplish….energy that could be applied toward more effective ways to improve the agency.

adapted and republished with permission from FDA Matters

Notes

Jim Greenwood, President and CEO, 2011 BIO STATE OF THE INDUSTRY ADDRESS. “Unleashing the Promise of Biotechnology to Cure Disease and Save Lives” http://www.bio.org/news/speeches/2011_greenwood_convention_speech.pdf

A more in-depth description of the BIO proposals is at: http://www.bio.org/aboutbio/promiseofbiotech.pdf

List of independent agencies: http://www.usa.gov/Agencies/Federal/Independent.shtml

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