Question

Suppose that a unit of the Food and Drug Administration (FDA) is responsible for subsidizing pharmaceutical companies to develop new drugs for treating certain difficult cancers. Because of the expense, most drug companies are reluctant to take on this work, and the few that do complain that it is more expensive than they anticipated given all the safety regulations they must follow. In response, the FDA decides to waive certain safety trials so that the remaining companies do not drop out of the initiative. The FDA's decision has the desired effect: most of the companies stay in the program. However, six months after the new drugs are released, they are found to have serious side effects, side effects that typically would have been noticed during some of the safety trials. What term describes the FDA's behavior in this situation?

a. implementation b. privatization c. regulatory capture d. oversight

Answer 1

The FDA's behavior of waiving safety trials to keep drug companies in a development program, which results in the release of unsafe drugs, is termed 'regulatory capture.' The public, who are exposed to potentially unsafe drugs, are the 'losers,' while pharmaceutical companies benefit.

Step-by-step explanation:

The behavior of the FDA as described in the situation where they waived certain safety trials to encourage pharmaceutical companies to continue developing drugs for difficult cancers, which led to the approval and release of drugs that subsequently caused serious side effects, is best characterized as regulatory capture.

This term describes a scenario where a regulatory agency, created to act in the public interest, instead advances the commercial or political concerns of the industries it is charged with regulating, often to the detriment of the public. In this case, by waiving safety trials, the FDA prioritized the pharmaceutical companies' interests over public safety.

The losers in such a regulatory environment are generally the patients and the public at large, who face the risks of using unsafe or inadequately tested drugs. On the other hand, the pharmaceutical companies can be viewed as winners because they are able to bring their products to market faster and at a lower cost, despite the potential risks to consumers.