FDA vs. the Individual - Pharmaceutical Executive


FDA vs. the Individual

Pharmaceutical Executive

At this point, the inquiry shifts to a second question: what knowledge is available about individual variations? If all that is known is that there is a variance among individual cases, without any knowledge of where particular individuals lie on the distribution, the harm from any ban is relatively slight. Since individuals do not know where they lie, as a first approximation, they will act as though they are located at the mean. They would thus make the same decision as the FDA.

At this point, the only loss from the ban stems from the attitude toward risk. If the FDA is risk averse, it will ban products with high variances that some gambling individuals would be prepared to take. In most cases, however, the elaborate systems of downstream control are put into place precisely because ordinary patients and their physicians can make an intelligent estimate of the patients' place on the distribution.

Just as physicians can determine without the FDA's assistance which individuals are good candidates for surgery, so they can also determine which are good candidates for any drug regime. In general, the ban makes sense as a matter of first principle only on highly restrictive assumptions in which patients will not only fail to process the available information but also stumble even if they can purchase the best assistance that money can buy. Hence, presumptively, the FDA should not have the power to ban at all, except in cases that deal with impure or adulterated products.


The case against the FDA power in this regard is only strengthened when one looks at the ostensible tests that are used to decide whether to put a ban in place. As we have seen, the operative terms in question deal with effectiveness and safety, which are left undefined under the Food and Drug Act. But why should the act leave its key terms undefined when so much turns on them?

Here the answer has more to do with distribution of political power than with linguistic inquiry. Stated as absolutes, the terms "safe" and "effective" suggest that we work in a dichotomous universe, where the difference between safe and unsafe is as categorical as the difference between driving on the correct side and the wrong side of the road, whether in the United States or the United Kingdom. The same arguments could be made for effectiveness.

Yet, of course, this is pure myth, for the moment the FDA or anyone else has to deal with concrete cases, the task is always to compare the risks and benefits of alternative strategies.

In the Vioxx and Celebrex debate, for example, no one thinks that you can describe, categorically, either or both of these drugs as safe or unsafe. The question is whether all things considered it is better to take one drug if the other has some elevated risk.

Even that determination depends on all sorts of refinements, given that there is never a uniform response to any given drug. Any FDA finding that a drug is safe and effective cannot possibly be read to mean that it has no adverse side effects and that it works a cure in 100 percent of the cases. We are dealing with wonder drugs, but not ones that have supernatural power.

So literalism is not a viable way to interpret the statutory command unless we are prepared to acknowledge at the start that no drug is good enough to make the cut. Any realistic determination, therefore, has to ask the question of how safe and effective any given drug is, not only for one individual but across large populations. In dealing with this question, the FDA cannot take the position that a drug should be banned just because it has adverse effects in a single class of cases. No one would market (even if unbanned) thalidomide for pregnant women in the first trimester.

Thus far the argument has been that bans have limited social utility. But federal law gives the FDA unquestioned power to ban from the marketplace drugs that it judges to be unsafe or ineffective. The question is thus sensibly asked how these general propositions about decisions could be translated into a regulatory context that treats that power as unquestioned.

The blunt answer is that there is no good way to back off a statutory command that is too stringent for its own good. But by the same token, the language in question could be interpreted by the FDA to mean that it should ban products only when their release is likely to do more social harm than good.


blog comments powered by Disqus

Source: Pharmaceutical Executive,
Click here