Former HHS Official Says FDA's Inherent Flaws Remain Unaddressed

The FDA's inability to evolve and keep pace with the rapidly advancing pharmaceutical industry has left it with a wide array of problems, particularly on the drug safety front, asserts Eve Slater, former assistant secretary for health at HHS.

"[The FDA's] progress since the passage of the Prescription Drug User Fee Act [in 1992] has been insufficient and the [agency] must evolve beyond satisfying the appetite of industry for faster approval of drugs," wrote Slater in an article published in The New England Journal of Medicine.

"The FDA must strengthen its postmarketing safety surveillance and its oversight of the advertising and promotion of drugs. It must continually develop and sustain its capability in emerging areas of science. Perhaps most important, its expertise must be brought to bear in the control of surging drug costs," Slater wrote.

Slater said the issue of postmarketing surveillance has never been more important in light of several recent drug safety controversies, such as Merck's recall of Vioxx (rofecoxib) in September 2004 and the FDA's health advisory for naproxen in December 2004.

The FDA's current mechanisms for reporting and reviewing postmarketing data are "fraught with opportunities for human error," said Slater, who noted that the FDA lacks a system in which adverse event reports can be managed in an organized and timely fashion.

To view an abstract of Slater's article, go to http://content.nejm.org/cgi/content/short/352/3/293 (http://content.nejm.org/cgi/content/short/352/3/293).

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