5 questions: Kennedy on the FDA

An occasional feature in which a medical expert answers five questions on a science or policy topic of interest to the Stanford community

Donald Kennedy

The Food and Drug Administration is under intensive scrutiny. Revelations about the potential risks of the arthritis medicine Vioxx and certain antidepressants have caused widespread alarm, but the concerns go beyond a few drugs. Critics charge that the agency is not capable of assessing whether drugs are safe and effective. To gain some perspective on the challenges facing the FDA, Paul Costello, executive director of the medical school’s Office of Communication and Public Affairs, turned to Donald Kennedy, FDA commissioner from 1977 to 1979 and president-emeritus of the university. Kennedy is now editor-in-chief of Science magazine.

1 In recent testimony to the U.S. Senate, David Graham, MD, a scientist at the Food and Drug Administration, accused the agency of being “incapable of protecting” the nation against dangerous drugs. That’s a pretty frightening concept if it’s anywhere near the truth.

Kennedy: Graham based his testimony on several drugs. Two of those he mentioned have been handled carefully and responsibly by the FDA, including the addition of warning labels when a counterindication appeared. Graham has done some good work on drug reaction epidemiology in the past (he was involved in the Vioxx post-marketing analysis). But his statement to the Senate was unnecessarily scary.

2 Do you worry that a crisis of confidence in the FDA will expand and potentially cripple the agency?

Kennedy: The combination of the Vioxx scandal and the FDA’s delay in warning about antidepressant use in children has lowered public confidence to a degree. But the FDA’s general reputation is deservedly good. The real problem is the absence of an adequate system for monitoring the safety of already-marketed products, and that’s not FDA’s fault.

3 What are your thoughts about calls for the creation of a new safety board?

Kennedy: Several observers of the scene have suggested that it’s time to invent a new regulatory agency whose function will be to conduct and report clinical trials, which would be paid for by the industry.

There is some merit to this idea. Still, since it will be a political non-starter for at least the next four years, it will be better to focus on more near-term solutions, like giving the FDA’s office of drug safety the funding and authority it needs to establish an effective adverse drug reaction reporting system.

4 Are you concerned that either politics or financial business interests are undermining safety issues?

Kennedy: Probably there is some of both. Congress and the pharmaceutical industry both push for approvals from time to time. Plans for a required national registry of clinical trials would help, with ALL results, negative and positive, made publicly available.

5 Earlier this year, the FDA blocked the so-called morning after pill, Plan B, from being sold over the counter. This seems to be one of several instances in which social policy is trumping scientific data. Is this a trend that you fear will grow over the next four years?

Kennedy: There is more to be said on this topic than we have space for. Briefly: yes, and the action with respect to Plan B is part of a growing volume of cases in which the Bush administration has substituted political judgments for science-based conclusions.