FDA 'Timid and Toothless,' NEJM Editorial Claims

A lack of leadership combined with increasing pressure to approve new drugs quickly and the Bush administration's antiregulatory philosophy has left the FDA "timid and toothless," according to an editorial in The New England Journal of Medicine (NEJM).

The agency's shortcomings have become especially apparent in the face of recent drug-safety controversies over Cox-2 inhibitors and antidepressant use in children. Those situations have "raised questions about the agency's ability to fulfill one of its fundamental missions -- to ensure that the benefits of prescription drugs outweigh their risks," writes Susan Okie, a Harvard University-trained family physician and a contributing editor to the NEJM.

The FDA's problems have been exacerbated by a lack of strong and independent leadership, according to Okie, who says this "leadership vacuum" has contributed to an "atmosphere that stifles debate and discourages some employees from expressing scientific concerns about drugs."

Okie says the leadership problems extend throughout the top of the agency, which continues to be populated with officials operating in "acting" roles. Along with acting Commissioner Lester Crawford, several other top officials are also operating in an acting capacity, including Deputy Commissioner Janet Woodcock, Center for Drug Evaluation and Research Director Steven Galson and Office of Drug Safety Director Ralph Lillie.

In addition to the leadership problems, the FDA has struggled to balance the increasing demand for shorter drug-approval times with the growing need for strong drug-safety measures. This shortcoming can be traced, in part, to the implementation of the Prescription Drug User Fee Act, which Okie says has placed more emphasis on the application review process than the postmarketing review process. The pressure to review applications quickly has also de-emphasized the importance of scientific debate, she says.

To view an abstract of the editorial, go to http://content.nejm.org/cgi/content/short/352/11/1063?query=TOC (http://content.nejm.org/cgi/content/short/352/11/1063?query=TOC).