> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Make FDA Independent: 7 Former Commissioners
- URL: https://www.fdaweb.com/make-fda-independent-7-former-commissioners/
- Published: 2019-01-08T12:00:00.000Z
- Updated: 2026-09-15T00:52:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143106

Seven former FDA commissioners who served more than 30 years total in both Democratic and Republican administrations say the agency should be taken away from HHS and reconfigured into an independent federal agency. The seven spent 18 months examining FDA’s position within the federal government, its reporting relationships and required layers of executive branch review, the economic and health consequences of delayed decision making, the growing responsibilities that have been placed on FDA, and the structure of other federal agencies. The study, supported by the Health, Medicine, and Society Program of the Aspen Institute, involved **Robert Califf**, **Margaret Hamburg**, **Jane Henney**, **David Kessler**, **Mark McClellan**, **Andrew von Eschenbach**, and **Frank Young**.

Describing their proposal in a *Health Affairs* [commentary](https://www.healthaffairs.org/doi/10.1377/hlthaff.2018.05185?ref=fdaweb.com), the seven say that in a world of rapidly advancing scientific knowledge, emerging and persistent threats, and intense global competition, “it is essential that the agency leverage science to advance the public health as quickly as possible…. We believe that the national interest would best be served by a strategy that would enable FDA to act without the delays inherent in multiple levels of clearance, protect its integrity, promote reliance on consistent science-based regulation, and ensure that the American public has access to the best that science and industry can offer.”

The commissioners cite 10 overarching objectives for an independent FDA: 

- · promote and protect the public health;
- ensure predictable decision making that is firmly grounded in scientific evidence and allows safe and effective products to reach the market in a timely fashion;
- speed development of biomedical innovations;
- enhance agency transparency and sustain public confidence;
- ensure the safety of FDA-regulated imports;
- foster development and availability of medical products that respond to deliberate and naturally emerging public health threats;
- promote the agency’s capacity to act swiftly in an emergency;
- design a legal and enforcement framework that is efficient and accountable;
- improve access to external scientific advice from a wide range of sources; and
- ensure that stakeholders have ample opportunity to inform agency decision making.

After examining several independent federal agencies, the seven say they have concluded that no single model could be adopted in its entirety, but features of the Environmental Protection Agency, Federal Trade Commission, Securities and Exchange Commission, and Social Security Administration could serve as models. They write that four specific attributes of an independent agency that would safeguard the sound, science-based decision making and transparency that are essential to FDA’s mission are: **(1)** the agency should be led by one person appointed by the president and confirmed by the Senate; **(2)** the agency should have rule-making authority in accordance with congressional enabling legislation and intent, and with appropriate and judicious input from the executive branch; **(3)** oversight of the agency by the Office of Management and Budget (OMB) should be limited to significant regulations and policy development, with transparency embedded and limitations clearly defined; and **(4)** the agency should have litigation authority in coordination with the Justice Department.

Recognizing that such a change is an ambitious goal that would require federal legislation, the former commissioners call on HHS to take these interim steps to ensure FDA’s capacity to keep pace with rapidly evolving knowledge: 

- identify, in consultation with the FDA commissioner, opportunities to streamline the current system of multilayered, executive branch oversight of FDA decision making;
- formalize more direct communication between the HHS secretary and commissioner so that timely decisions can be made on high priority issues;
- define the criteria for determining which regulations would be subject to OMB review and discontinue OMB review of guidance documents and communications with Congress;
- allow FDA full recruitment and hiring authority; and
- · enhance the independence and robustness of the scientific advisory system.

The commissioners conclude that “FDA policies and actions are not driven by partisan politics. The scientific foundation for its decision making is guided by legislation that almost invariably has strong bipartisan support. We believe that our recommendations fit squarely within the bipartisan tradition of keeping the agency as up-to-date and effective as possible. Carrying out these reforms would enable FDA to better fulfill its increasingly complex, challenging, and critical mission to promote and protect the health of the public.”

A full explanation of the commissioners’ analyses, deliberations, and recommendations is in an Aspen Institute [report](https://assets.aspeninstitute.org/content/uploads/2018/10/FDA-Independence-White-Paper-Aspen-Institute-1.pdf?%5Fga=2.122727502.498433816.1546958157-1469496549.1546530145&ref=fdaweb.com).