A t the Aspen Institutes Ideas divisions it is charged with - PDF document

The Case for the Food and Drug Administration as an Independent Agency By Ralph S. Tyler * A t the Aspen Institute’s Ideas divisions it is charged with oversee- studied, drafted, and reviewed the Festival in June 2016, six former ing. Nevertheless, given the structural comments on the proposal. Commissioners of the Food relationship between HHS and its The rationale for why FDA should and Drug Administration (FDA), operating divisions, HHS exercises be independent is, in part, that FDA’s who served under Presidents of both an aggressive gate keeper function core mission is fundamentally differ- parties, voiced strong unanimous over the FDA. By statute, the HHS ent from that of other parts of HHS support for the idea that FDA should Secretary holds decision making and, indeed, is fundamentally differ- be an independent agency, and not, authority and thus HHS occupies the ent from the principal activities of as it is now, a subordinate “operat- superior bureaucratic position. most agencies of the federal govern- ing division” of the Department of With the Senate’s consent, the ment. FDA’s most important functions Health and Human Services (HHS). President appoints FDA Commissioners involve market access, product The tenure of these former commis- of accomplishment and distinc- review, approval, and removal. Before sioners spanned that of Frank Young tion, typically scientists or medical a new drug can lawfully reach the (1984–1989) to Margaret Hamburg doctors. This would suggest that FDA marketplace in the United States, (2009–2015). Each had confronted Commissioners operate with significant FDA must approve it. FDA is respon- different major issues, but their shared autonomy. But the truth is otherwise. sible for assuring the safety of the vast conclusion was that the present struc- The White House’s Office of majority of the nation’s food supply. ture does not best serve the country’s Management and Budget (OMB), For the past few years, FDA also has public health needs. Professor David through its Office of Information and been our nation’s tobacco regulator, Carpenter, who has extensively Regulatory Affairs, exercises powerful charged with reducing tobacco studied the FDA, is among those who oversight, if not literally veto author- smoking and its associated health risks support the agency’s independence. ity, with respect to agency regulations and costs. Each one of these areas of See Daniel Carpenter, Free the F.D.A. , and policies. This authority is set forth responsibility—and, of course, there Op-Ed., NY T IMES (Dec. 14, 2011). in Executive Order 12866 issued are many other examples—would The incoming national administra- in 1993 by President Clinton and alone be a very substantial policy tion and Congress should heed this followed by his successors. See 58 Fed. and operational undertaking. The latest call and act. Reg. 51735 (Oct. 4, 1993). The White totality of FDA’s areas of responsibil- HHS is a cabinet level department House thus operates as a significant ity encompasses a wide swath of the under which sits various operating check on a FDA Commissioner’s economy and present FDA, on a daily divisions, each of substantial size. policy initiatives. The point for basis, with enormous operational tasks These operating divisions include, present purposes is that FDA’s loca- and challenges. among others, FDA (regulating food, tion within HHS means that a FDA In contrast to FDA, the activities of both human and animal, drugs, Commissioner’s path to the White most of the domestic policy agencies medical devices, biologics, dietary House is impeded, not direct; absent of the federal government, including supplements, and tobacco), Centers extraordinary circumstances, the most of the components of HHS, for Medicare and Medicaid Services, Commissioner must go through HHS. involve setting and enforcing rules National Institutes of Health (medical FDA matters do not, and as a practical and policy and, in some instances, research), and Centers for Disease matter cannot, reach OMB without distributing funds to the states, to Control (public health research, first passing through HHS’s thick local governments, or others in the education, and data collection). filter. Before the FDA Commissioner form of grants, direct payments, or The scale, diversity, and techni- can get to the White House with a otherwise. While FDA performs all of cal complexity of the activities proposed regulation, for example, the these functions, FDA also has direct undertaken by the parts of HHS are Commissioner’s proposal is subjected hands-on operational responsibilities. remarkable. HHS lacks staff with to HHS scrutiny, review, and often FDA determines whether products expertise and knowledge comparable extensive modification. The HHS staff upon which every American depends to the expertise of the staff of the exercising this review lack the techni- every day may enter or remain on the cal and scientific qualifications of the market. FDA’s operational functions Commissioner and the FDA staff who range from inspecting tons of seafood * Partner, Venable LLP; Chief Counsel Food and Drug Administration 2010-2011. 26 Administrative & Regulatory Law News Volume 42, Number 1