Magazine article Clinical Psychiatry News

Should Experts with Potential Conflicts of Interest Be Allowed to Serve on FDA Advisory Panels?

Magazine article Clinical Psychiatry News

Should Experts with Potential Conflicts of Interest Be Allowed to Serve on FDA Advisory Panels?

Article excerpt

YES

What is the best thing for patients? That is the key question. Patients are best served when the experts who have the most knowledge about a medicine or disease advise officials at the Food and Drug Administration.

These individuals may receive funding from a variety of sources, from pharmaceutical companies to the National Institutes of Health to universities and foundations.

Legislation aimed at preventing the leading experts from advising the FDA because a portion of their funding comes from a particular source would serve the best interests of neither science nor patients. Certainly, however, it is clear that both the FDA and the public have a right to know about the existence of potential conflicts of interest.

The system must be transparent. All affiliations and financial support should be made known to the FDA and to the public.

If a member has a financial or other conflict, it should be known at the time and considered as the debate is taking place. Officials at the FDA can take any bias into account when they evaluate an advisory panel's advice. The expert panels are only advisory, and the officials at the FDA make the final decision.

As a practicing physician, I think excluding the people with the most knowledge could be detrimental to patient care. The issues that FDA advisory panels tackle are complex and often center around genuine scientific disagreements. In that environment, it's important to have a range of opinions and the greatest expertise available.

When panels are being asked to weigh benefits to one segment of the population against risks to perhaps a smaller subpopulation, we need panel members who have had the greatest exposure to the conditions and products being discussed.

This can be especially true in cases of treatments for rare diseases.

The FDA faces a tough challenge in protecting the public's health, and the agency is entitled to get the best advice from the best experts in the field.

The greatest defense against any bias these individuals might bring to the table is a rigorous process of disclosure.

Paul Antony, M.D., M.P.H., is the chief medical officer for the Pharmaceutical Research and Manufacturers of America.

NO

The FDA should steer clear of individuals who have a significant financial conflict of interest when choosing members of its advisory committees. …

Search by... Author
Show... All Results Primary Sources Peer-reviewed

Oops!

An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.