Rigorous Policy Pilots: Experimentation in the Administration of the Law

By Chien, Colleen, V | Iowa Law Review, July 2019 | Go to article overview

Rigorous Policy Pilots: Experimentation in the Administration of the Law


Chien, Colleen, V, Iowa Law Review


I. Introduction

"The country needs and, unless I mistake its temper, the country demands bold, persistent experimentation. It is common sense to take a method and try it: If it fails, admit it frankly and try another. But above all, try something."1

- Franklin Delano Roosevelt, Address at oglethorpe university, May 22, 1932

In the fall of 1960, the Food and Drug Administration ("FDA") received an application for a drug for treating morning sickness. Already approved and sold in dozens of countries,2 "Kevadon" was well-positioned for approval and entry into the united States. But its reviewer, a canadian-born physician named Frances Kelsey, wasn't convinced. Over several months and rounds of document exchanges, she continued to find evidence of the drug's safety and effectiveness lacking. The manufacturer mounted a high-pressure campaign and complained about Kelsey, whom they called a "petty bureaucrat" to her boss.3

The drug-better known by its generic name, thalidomide, and never approved for morning sickness in the United States-was later revealed to be the source of numerous horrific birth defects.4 Kelsey was lionized and bestowed with honors.5 But while Kelsey's fame is well-deserved, the story has a darker legacy. As Vincent DeVita, former head of the National Cancer Institute, describes in The Death of Cancer, this episode "sent the message to those who worked at the FDA that the way to do right by people was to say no."6 The subsequently enacted Drug Regulation Act put drug discovery out of the reach of all but the largest companies7 and bred the risk-aversion for which the agency is known,8 according to critics. One way the agency stays out of trouble is to keep risky medicines off the market, a good thing. But there are "no awards for getting a good drug quickly into the public domain."9 In fact after a prolonged delay, thalidomide returned to the market as an effective treatment for leprosy, blood cancer, and multiple myeloma.10

In the government, fear of making a Type 1 or "false positive" error -taking a mistaken step-leads to an overabundance of Type 2 or "false negative" errors-failing to take a productive step. At root, however, is the problem of "what [the] government doesn't know," regarding what changes to law or policy to consider taking, what the impact of such changes might be, and which among several potential changes is most likely to achieve a policy goal,11 all topics about which there may be many opinions, but little relevant evidence. Uncertainty about whether a law or policy change will achieve its intended purpose, fear of making a mistake in the face of this uncertainty, and institutional inertia all contribute to status quo bias-whether in favor of preserving regulations that don't work or failing to adopt new policies that do.12

One way to address both the knowledge gap and risk aversion in policy development is by introducing a temporary change to law or policy for the purpose of learning from it, through a "policy pilot." Implemented with rigor, through the application of, "well-designed and well-implemented methods tailored to the questions being asked"13-rigorous policy pilots are a generative yet under-used tool for addressing informational deficits that stand in the way of developing effective law and policy.

The range of open questions in law and policy that can be addressed by pilots are wide-ranging. They include, for example, the question of how giving a universal basic income ("UBI") to individuals impacts their well-being and employment. In 2017, the Finnish government began tracking the outcomes of 7,000 unemployed citizens, about a third to which it gave $600 a month, to address this question;14 several U.S. jurisdictions are planning their own tests.15 Also unknown is how the administration of patent law and issuance of quality patents best advance the Constitutional goal of "promot[ing] the progress of science and useful arts."16 Over the last decade, the United States Patent and Trademark Office ("USPTO") has run numerous pilots to address this question. …

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