FDA'S REVOLVING DOOR: RECKONING AND REFORM.

• Author: Karas, Laura

INTRODUCTION 2 I. RECENT CONTROVERSY AT THE FDA 7 II. FEDERAL REVOLVING DOOR LAWS AND THE THEORY OF REGULATORY 16 CAPTURE A. The "Revolving Door" Between Government and the Private Sector 16 B. Post-Government Employment in Industry as Regulatory Capture 23 C. "Revolving Door" Lessons from Outside of the FDA 33 III. BEHAVIORAL INSIGHTS INTO THE RISKS POSED BY PROSPECTIVE POST-GOVERNMENT EMPLOYMENT IN INDUSTRY 38 A. The Revolving Door Through the Lens of Gift-Giving 40 B. The Power of Valence: Approval Versus Rejection 45 IV. AGENCY DISCRETION AND THE PRINCIPAL-AGENT PROBLEM 46 V. ADDRESSING THE RISK OF UNDUE INFLUENCE FROM THE REVOLVING DOOR:OPTIONS AND PROSPECTS FOR REFORM 50 A. Transparency and Enhanced Post-Employment Restrictions 53 B. Checks on Agency Discretion 57 1. Intra-agency Checks 58 2. Extra-agency Checks 63 CONCLUSION 65 INTRODUCTION

A more than century-old problem continues to plague government at all levels: the movement of government officials through the so-called "revolving door" between government and the private sector. The frequency and fluidity with which government employees alternate between public-serving roles and private-sector roles, sometimes but not always representational in nature, remain an enduring cause of consternation and mistrust. Time-limited restrictions on representational activities and influence-peddling after officials leave government employment have provided an imperfect bandage for a lasting problem. (1) The U.S. Food and Drug Administration (FDA), guardian of the safety and effectiveness of our nation's pharmaceutical therapies and overseer of a variety of consumer products, is not immune from the revolving door phenomenon, especially as it entails government-to-industry job transitions. (2) An investigation by the peer-reviewed journal Science of 16 FDA medical examiners who later left the agency found that 11 took post-government employment with the companies that they had formerly regulated. (3) Jeffrey Siegel, for example, an FDA regulator who oversaw review of the New Drug Application ("NDA") for Genentech's Actemra (tocilizumab) while at the FDA, later joined Genentech as Global Head of Rheumatology and Rare Diseases. (4) Former FDA Commissioner Dr. Scott Gottlieb joined the Board of Directors of Pfizer within four months of announcing his resignation as FDA commissioner in early March of 2019, a rapid pivot back to industry that drew pointed criticism from many. (5) Among Gottlieb's achievements as commissioner was a Biosimilars Action Plan to promote the development of follow-on versions of biologic products. (6) Pfizer happens to be a leading maker of biosimilars. (7)

Gottlieb is not unique among FDA commissioners in availing himself of post-FDA employment in industry; in fact, news sources report that every former FDA commissioner but one from the early 1980s through Gottlieb's tenure ending in 2019 held a position in the pharmaceutical industry after leaving the FDA. (8) The most recent former FDA commissioner, Dr. Stephen Hahn, accepted executive positions in a biotech-focused venture capital firm, Flagship Pioneering, and a device company, YourBioHealth, after leaving his post at the FDA. (9) Flagship Pioneering happened to have founded Moderna, maker of a COVID-19 vaccine that received an Emergency Use Authorization ("EUA") during Hahn's tenure and that yielded Moderna billions of dollars in sales revenue. (10)

At first blush, it may seem reasonable for former top FDA regulators to put their knowledge and expertise to use where it is most relevant and most highly valued, which for many former FDA regulators is in the biopharmaceutical and biotechnology industries. And, for the more than 18,000 full-time civilian employees of the FDA, a post-agency job in a private-sector company of the kind the FDA regulates might be the most readily attainable and most logical career move. (11) But, for more than a century, the United States has had federal ethics laws that place limits on the private-sector, post-government employment of former government officials. These laws aim chiefly at deterring the use of confidential government knowledge to advance private-sector objectives and preventing unseemly use of government connections to influence the agencies, departments, or other seats of government from which employees depart. (12)

An issue related to the revolving door is the influence of politics at the FDA, hardly a new concern (13) but one that has attracted renewed attention during the COVID-19 pandemic. (14) Scholars and former regulators have debated whether the FDA should have greater insulation from the executive branch and perhaps even be remodeled as an independent agency. (15) some have suggested "drawing a line between [the FDA's] broad policy decisions, which elected and appointed officials may appropriately influence, and decisions about specific applications before the agency, which should be shielded from such influence." (16) Yet the practicality of a workable division between overarching policy on the one hand and specific applications or scientific evaluations, on the other, is dubious. Policy inevitably trickles down to affect specific decisions, including decisions on drug applications before the FDA. (17) Ultimately, the "scientific components" (18) of the FDA's work cannot be meaningfully detached from its value-laden decisions about the rapidity of drug approvals, for example, or the level of evidence needed to approve them. Politics may or may not have a more legitimate role to play in FDA decision-making than does industry influence, but undoubtedly it represents a nonnegligible influence that informs the agency's work. Any discussion of politicization of the FDA should be reframed as part of a larger discussion over the various forces and unseen influences that affect FDA decision-making and the degree to which each should be tolerated, eliminated, or mitigated.

This Article proceeds in five Parts. Part I frames the discussion of revolvingdoor concerns with respect to the FDA by highlighting recent controversy over some of the FDA's decisions on drug applications that have called into question the neutrality and independence of high-level FDA regulators. This Article is not meant to suggest that any particular FDA official has engaged in improper acts or was improperly motivated by outside influences. Rather, this Article seeks to address a larger problem raised by these high-profile controversies: the potential for industry-related conflicts of interest (and this Article focuses on one particular source of conflict, the prospect of post-agency employment in industry) to influence--intentionally or unintentionally, consciously or unconsciously--senior FDA officials' most critical decisions. Part II reviews the primary federal statutory provisions that address the revolving door between government and the private sector, considers reactions to post-employment restrictions in legislative history, and puts forth a conception of post-agency employment in industry as a form of regulatory capture. Part III utilizes insights from behavioral science and critical realist scholarship to examine what impact potential future employment in industry could have on agency officials while in office and whether this impact can be properly mitigated by traditional strategies such as time-limited cooling-off periods, blind reliance on good intentions, or efforts at transparency. Part IV examines the fiduciary role of agencies such as the FDA and reframes agency discretion in light of the familiar principal-agent problem. Part v considers various mechanisms to address the risk of biased decision-making that the revolving door generates and ultimately argues in favor of additional process safeguards that can serve as a check on exercises of discretion at the agency.

1. RECENT CONTROVERSY AT THE FDA

   The COVID-19 pandemic has placed a spotlight on the critically important work of the FDA to approve therapeutics, including drugs, vaccines, and other biologics, that promote the public's health. Yet, over the past two years, the FDA has come under fire for approval decisions that many within and outside of the agency have criticized as lacking sufficient evidence of safety or efficacy. The FDA issued, and fewer than twelve weeks later revoked, an EuA for antimalarial drugs hydroxychloroquine and chloroquine, determining in June 2020 "based on a review of new information and a reevaluation of information available at the time the EuA was issued" that the criteria for EuA authorization were no longer met. (19) In its revocation decision, the FDA concluded that "it is no longer reasonable to believe that... [hydroxycholorquine and chloroquine] may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks." (20) The FDA acknowledged on its website that "[t]he EUA was based upon limited evidence that the medicines may provide benefit," (21) and that randomized clinical trial data had failed to show evidence of clinical benefit in hospitalized COVID-19 patients, while serious and sometimes fatal arrythmias--well-known side effects of these drugs--were observed. (22) Whether the EUA was properly granted in the first place remains an open question, but the incident sparked criticism from former FDA officials and others who considered the decision rash and potentially politically motivated. (23)

   In June 2021, the FDA approved the Alzheimer's treatment Aduhelm (aducanumab) (24) over objections from the FDA advisory committee assembled to review it and over a chorus of objections from "senior agency officials [who] resoundingly agreed that there wasn't enough evidence it worked." (25) Hailed by the agency as the "first therapy to target and affect the underlying disease process of Alzheimer's," (26) Aduhelm received approval under an expedited...