David Beier Op-Ed: FDA Reform: It’s Time To Act, But Not As An Independent Agency

By Dan Troy, Dan Mendelson, David Beier

Link to full article on Health Affairs


In a rare exercise in bipartisan leadership, former Food and Drug Administration (FDA) commissioners of both political parties called, in the January 2019 issue of Health Affairs, for the FDA to become an independent agency. As former federal officials, we support a strong, vibrant, and well-funded FDA, but we depart from this consensus recommendation that the FDA become an independent agency. We understand the need for more trust in FDA decision making and rulemaking, as well as less bureaucratic meddling by its parent agency, the Department of Health and Human Services (HHS), and the White House Office of Management and Budget (OMB). However, we believe the negative consequences of hiving off the FDA into a separate agency are too risky and likely to outweigh any benefits.

The essence of the plea from former commissioners recalls the plight of Gulliver being tied down by the miniscule Lilliputians. The former commissioners complain about the degree of micromanagement by HHS and the flyspecking that occurs in the rulemaking process by the bureaucrats at the OMB. But these problems are small compared to the undertaking they propose—and solvable within the existing statutory structure. Better management at HHS does not require a change in law—it can be accomplished by the HHS secretary. More thoughtful coordination with the OMB does not require the substantial undertaking of congressional action and a presidential signature.

The first risk of the call for an independent FDA is that it misses some salient benefits about the FDA’s place within HHS. First, there are natural alliances and overlapping responsibilities between the FDA and the National Institutes of Health. The former regulates product approvals for drugs, biologics, and medical devices. The latter agency funds cutting-edge research that can lead to the development of products that the FDA regulates. The examples of cooperation between the two agencies are many but include work on AIDS, Alzheimer’s, opioids, antibiotic resistance, orphan drugs, and international cooperation.

Another area of collaboration is the relationship between the FDA and the Centers for Medicare and Medicaid Services (CMS). CMS is one of the largest health insurance entities in the world and also regulates important processes such a clinical laboratory testing in hospitals. In addition, CMS cooperates with the FDA to conduct parallel reviews of certain products so that important new products are approved for the market and payment parameters are set simultaneously. More collaboration between the FDA and CMS is necessary as drug policy increasingly focuses on product value and value-based purchasing is deployed in Medicare, Medicaid, and other public programs. These kinds of collaborations would be at risk with an independent FDA because there is a risk that an independent agency will not be in policy alignment with the Executive Branch.

The second risk of an independent FDA is that it would be governed by a different set of standards for its leaders than apply to all other federal agencies. In general, independent agencies are governed by a board or commission whose Senate-confirmed officials do not serve “at the pleasure of the president” and can only be removed for cause. Even if an independent FDA were run just by a single official, the limitations on the authority of the president to remove that person would perversely make that individual less responsible to the policy preferences of the secretaries of the Departments of the Treasury, State, and Defense, as well as HHS. This would diffuse, not enhance, political accountability.

And it’s important to acknowledge that the president’s program—which is conceptualized and implemented through accountability to cabinet secretaries and the OMB—is important for directing the activities of the FDA. For example, presidential initiatives to lower drug prices bear on the rapid approval of generics but also on how such products are purchased by Medicare and Medicaid. In addition, policies to address the opioid crisis draw on the expertise and regulatory structure of the FDA, as well as many other federal agencies—inside and outside of HHS. FDA coordination and expertise is invaluable in formulating this program and can best be incorporated when the FDA is part of the vibrant debate that goes on among HHS operating divisions.

The third risk is that an independent FDA would be able to represent its views in litigation without reference to well-established policies of the Department of Justice (DOJ). (Agencies within HHS, on the other hand, must follow DOJ policies.) Failure of the FDA to follow the DOJ’s central rules on matters such as jurisdiction, standing, immunity, and remedies could leave the court system with inconsistent positions being taken by different parts of the US government. This phenomenon is also potentially present if the FDA was to adopt a different view on points related to foreign policy than the Departments of Defense or State, or the US Trade Representative.

In addition to the risks above, there are benefits to be secured from working within the HHS and OMB structures to make sure that the tools and techniques of economic analysis are consistently applied to rulemaking involving similar matters. The OMB’s Office of Information and Regulatory Affairs may seem cumbersome to the leader of an HHS operating division, but it has consistently been a highly useful check on the risks of excessively expensive regulation. It’s also a way that Congress and the president can ensure consistency across government in the application of expertise in regulatory policy.

In sum, there are real benefits to keeping the FDA within the HHS structure—benefits that promise to strengthen the health care system. That said, we owe it to the public and to the staff of the FDA to increase the speed and agility with which the agency can operate, now and in the future.

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