Critics Say FDA Drug-safety Oversight Needs To Be More Independent

Big Pharma Tells IOM Panel, However, No Major Changes Are Needed

In the January 12, 2006 edition of the New England Journal of Medicine (NEJM), an article by Wayne A. Ray and C. Michael Stein calls for Congress to establish more independence and authority as concerns FDA drug-safety oversight so as to better protect patient from the risks of serious prescription drug side effects. Ray is a professor of Preventive Medicine at Vanderbilt University, and Stein is associate professor of Medicine and Pharmacology at Vanderbilt. 

In their NEJM article, "Reform of Drug Regulation -- Beyond an Independent Drug-Safety Board"  (subscription required),  Wayne Ray and Michael Stein assert that the FDA should have independent offices for (1) the approval of a new prescription drug for sale and (2) the monitoring of that drug's safety profile after approval.  The authors also suggest that a new FDA office -- the Center for Drug Information -- should be created to provide doctors with emerging information about drug risks, and promptly issue drug-safety warnings when necessary.  From the NEJM article:

We thus propose a reformed regulatory authority with three distinct functions (Table 2): new-drug approval, post-marketing studies, and drug information. We envision three independent but cooperative centers within a unified agency, although other administrative structures are possible. The new centers would be funded by a tax on pharmaceutical sales. For the reforms to work, the centers must be provided with adequate statutory authority, sufficient funding, and protection from inappropriate political pressure.

In addition, on January 17, 2006 Wayne Ray presented these points to an Institute of Medicine (IOM) panel, which was asked by the FDA to evaluate the agency's drug-safety oversight and recommend changes.  The FDA requested this IOM evaluation last year after the agency was criticized for being slow to act as regards the Vioxx debacle as well as safety problems with some other prescription drugs. 

In advance of his IOM testimony, in an interview with Kerry Young, of Bloomberg News, Wayne Ray pointed out that patients are largely unaware of how little authority the FDA has to update prescribing information given to doctors on drugs.

A recent example of this situation is how two drug companies effectively delayed for a year having to put the "black-box" warning on Elidel and Protopic about increased cancer risks that the FDA wanted placed on the package insert, or label, of those skin ointments.

On the other side of things, according to a January 19, 2006 article by Lisa Richwine, of Reuters, representatives of the drug companies told the IOM panel that while there may be room for some improvement, there is no need for any major change at the FDA.

• "Drug safety in the U.S. definitely needs improvement. It needs a careful, focused treatment, but I would argue not radical exploratory surgery," said Geoffrey Levitt, chief counsel for regulatory and research at Wyeth.
• "We think that moving oversight of safety to another federal agency seems extreme and could significantly stall incremental progress," said James Nickas, senior director of development at Genentech Inc.

This IOM panel regarding drug-safety oversight in the U.S. is scheduled to release a report in mid-2006 with any recommendations it has for changes at the FDA.

(Posted by: Tom Lamb)