The Food and Drug Administration (FDA) is the federal agency responsible for the health and medical safety of American citizens. As part of the FDA’s mission, it oversees the drug approval process in the U.S.—it requires every new drug to undergo multiple layers of safety-testing and risk-evaluation before they can obtain the approval for marketing. By virtue of this, it is able to screen out medicines that pose great risks. In other words, its role is to protect public health from the potential conflict of interest that may emerge in a profit-seeking market.

Despite this role, Bartley J. Madden argues in his book Free to Choose Medicine: Better Drugs, Sooner, at Lower Cost, that rather than serving the interests of patients, the FDA actually hurts Americans due to its long and demanding drug-approval process. He contends that the agency’s primary motivation has become to preserve its own reputation and to minimize its liabilities. And he makes the case for restructuring the FDA to better protect the health and medical safety of Americans.

Chapter One “Sacrificing Patients to the FDA” starts with several anecdotes of terminally ill patients who eventually succumbed to death due to being denied the opportunity to experiment with drugs still in clinical trial. They could not enroll in these trials because of various prohibitions. In other cases, large amounts of patients suffered from a lack of treatment because the medicines they needed were yet to complete the agency’s prolonged testing process. While these drugs could have potential harms as their safety tests didn’t yet meet the statistical robustness requirement, they often represented the best option available for the patients. The author then argues that it should be up to patients themselves to decide whether to use potentially risky drugs or not.

Chapter Two “Getting Drugs to Patients Is a System” applies a systematic lens. The author claims that such a lens is necessary when assessing the efficiency of a structure; otherwise different components could be caught up in their own local efficiency and the overall efficiency might be neglected and undermined. Along this line of thinking, the FDA, too entrenched in its local efficiencies and worldviews, has produced “bottlenecks” for the entire system of drug production. The FDA’s core approach in safety testing is clinical trials—trials that are implemented after the pre-clinical research and before the final review phase. These trials occur in three different stages with increasing demands in sample size and testing accuracy. While this framework is helpful for keeping dangerous drugs from markets, it proves to be extremely costly and time consuming. As Bartley points out: 1) the total average cost to develop an approved drug exceeds a billion dollars today; 2) a typical time period of a new drug making to the market from the lab is between 10 and 20 years. This severely discourages innovation and investment incentives (especially for small innovative biotech businesses that face tighter budget constraints), and its excessive delays can render an effective drug irrelevant by the time it is finally approved. While the system does provide access to these drugs for patients who are fortunate enough to enroll in clinical trials and to not receive placebo, it also denies access to the vast majority of patients.

In various places in the first two chapters, the author has indicated that the FDA staff has the incentive to avoid negative publicity which could be brought about by issuing premature approvals to drugs. Chapter Three “Analyzing the FDA’s Defense” shows, however, that besides being averse to such negative publicity, another rationale behind the FDA’s bias against streamlining access to drugs is that it would diminish the FDA’s ability to conduct randomized controlled trials (RCT). Successful RCTs require a large enough database that includes not only a group receiving the examined drug, but also a comparison group to receive placebos. Allowing patients speedier access to new drugs, on the other hand, will draw people away from this procedure as no one will voluntarily accept a placebo. Hence, the agency is incentivized to stick to the current approached. However, the author argues that this is an arbitrary trade-off made by the FDA to sacrifice today’s patients for the alleged benefits of future ones. The very fact that patients don’t want to enroll in an RCT for the fear of getting a placebo shows how unethical this method is.

In light of these costs of the FDA’s involvement in the drug development process, the author calls for an alternative system which will decrease the role of the FDA, and which will be able to provide better drugs, sooner, at lower costs. Chapter Four “Free to Choose Medicine” introduces this “dual-track” plan. In parallel to the existing FDA track featuring three trial phases, the author proffers another track (the Free to Choose Track) to be introduced in which patients can have access to drugs that have passed the second stage of clinical trials. In this way, not only will patients be able to acquire promising drugs sooner, but researchers will also be able to study the effects of not-fully-examined drugs from these willing patients. Although the information from these uncontrolled treatments may not be as systematic as those from an RCT, they can offer contextualized and individualized insights into the effects of a drug. In addition, the author calls for the design of a Tradeoff Evaluation Drug Database (TEDD) to be managed by the National Institute of Health, which will serve as an up-to-date public data repository of pre-mature drug uses.

Chapter five tentatively lays out the winners and losers of this potential reform. The FDA would certainly oppose the plan. The author also anticipates opposition from special interests such as trial lawyers because the plan will grant immunity to drug developers and doctors from lawsuits related to a drug’s adverse effects and hence will foreseeably shrink lawsuit businesses. On the upside, he envisions better drugs, sooner, at lower costs—echoing the theme of the book.

To me, however, there is a big confusion with this proposal. Why should the Free to Choose Track be implemented after the second trial phase? Although the inconveniences created by the FDA in drug productions are pronounced and well-known, FDA’s proponents will say that it is the watchdog indispensible to a safe and well-regulated drug market. The question then is to find the socially optimal point between drug innovations and benefits on the one hand, and drug safety and delays on the other. It is to this question that Bartley’s answer appears rather arbitrary and undefended. It might be that the author is concerned that a too drastic agenda such as further removing the oversight from the agency might generate strong opposition and backlash from the establishments. It might also be that he meant to work in broad strokes, so that detailed provisions and modifications can be filled in later on in the reform process. But in any case, the book fails to offer a rationale for why this alternative plan is structured the way it is.

Although the book does not take a pure economics approach, the author supports his arguments with various economics tools. His reflection on the behaviors and defenses of the FDA’s agents fits within the standard public choice argument. He also applies the Hayekian argument that prices serve as the mechanism to convey market knowledge and the argument that trials and errors are necessary for agents to better coordinate production and consumption plans. The FDA, on the other hand, he argues, only distorts the incentives faced by pharmaceutical companies and patients in an otherwise functional drug market. For example, he shows how a firm’s investment choice can be skewed toward marginally meaningful drugs because the costs for developing breakthrough drugs are artificially high. Likewise, small firms are forced to narrow their focus although other candidate drugs might be equally promising. His conclusion is essentially that these government interventions need to be scaled back.

Overall, the book is engaging and well-structured. It pinpoints a long-standing political issue that is yet to be solved. It is notable that many of the criticisms against the FDA in the book are in line with previous studies on the same subject matter. Ronald Hansen, for example, in his chapter in the 1995 edited book Hazardous to Our Health, has treated the “drug lag” problem created by the FDA’s regime of regulation. One finds Bartley’s argument similar to Hansen’s analysis. However, one important new contribution of this book is that it outlines a not-so-radical, and hence politically viable, blueprint to tackle the FDA reform step by step.