FDA vs. the Individual - Pharmaceutical Executive

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FDA vs. the Individual


Pharmaceutical Executive


Who should make decisions about drug safety—FDA or patients and doctors? In this excerpt from his important new book Overdose, the renowned (and ever controversial) legal scholar Richard A. Epstein argues that the current system overvalues risk, ignores individual differences, and needlessly deprives patients of valuable treatments.

It is well known that the FDA has authority to regulate not only for purity, but also for safety and effectiveness. On the first of these questions no one challenges the role of the FDA, either inside the industry or beyond it. But the issues about safety and effectiveness raise serious questions of institutional design, which are not well handled under the current regulatory regime. The key question is this: Where should decisions about drug safety and efficacy be made, upstream by the FDA or downstream by the individual drug user, aided by professional assistance?



The problem is not trivial because there is no inherent reason to assume that any viable solution will lodge all decisions at either the individual level or the collective level. Thus the question is how to partition the tasks between the two. One obvious argument in favor of centralized control is that the FDA can possess a level of expertise not available to ordinary consumers. But clearly this argument is not sufficient to resolve the matter, for ordinary people are not unaided in making decisions about drug use.

If the FDA decides to let a drug onto the market, no one is obliged to use it. Any mistake to permit the sale of a drug is therefore subject to downstream correction by individual users. But a decision to keep the drug off the market is impervious to downstream correction by individual users. In the alternative, the FDA could issue warnings, perhaps very severe warnings, as to the risks associated with product use.

The simple point is that despite their apparent affinity, warnings and bans start from different places within the legal firmament. The critical reason for distinguishing between them is that in the population at large, individuals will have widely varying perceptions of risk and widely varying willingness to undertake it. In other words, some who have received the warnings may nonetheless decide to run the risk, while others may not.

Of course, the warnings could well influence how that decision is made, but even the most imposing of warnings can be disregarded, especially by people who have already used a drug which they found helpful for their own condition.

If it is true that on balance the use of a drug does more good than harm, then a warning is socially destructive if it reduces use below the optimal level. The market information can be as much distorted by overgloomy predictions that lead to excessive caution as it is by exuberant industry-wide promotion that leads to excessive use. Both kinds of errors have to be taken into account.

Moreover, it is absolutely critical to understand that the FDA does not have any monopoly over warnings. Individual physicians and patients can consult other references that deal with drug interactions, read Web sites devoted to particular diseases or conditions, or throw darts at a target to make their decisions. Let the FDA warn away, and it will still be subject to competitive pressures from other individuals and groups that have their own testimonies and judgments to offer.

The emergence of any such voluntary market in warnings is yet another reason to deny the FDA any comprehensive power to ban, or even to issue black-box warnings that raise the costs of product distribution. The sources of information available—the FDA, drug companies, Public Citizen, and physicians groups—should in aggregate improve the overall level of decision making.

Owing to the possibility of imperfect competition in the warning markets, the hard question is, Why believe that the FDA is so reliable in its judgments that it should be allowed to make decisions another individual cannot reverse?

TWO KINDS OF ERROR

It is critical to begin with the standard distinction between Type I and Type II error, which is rightly stressed in virtually all works critical of the FDA chokehold on drug release. Type I error arises when a drug that should be kept off the market is allowed onto the market, where it causes visible harm to its users. Type II error arises when a valuable drug is kept off the market, thereby making it impossible for sick individuals to benefit from its use.


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