FDA’s Kessler to Leave but Agency Still Under Fire – WASHINGTON

 The sometimes controversial head of the Food and Drug Administration, David Kessler, will soon be gone but the agency will not have shed its critics.
Drug and medical device makers are pressing for even simpler and faster approval of their products, while consumer advocates are urging the agency to take a tougher line with those who flout its rules.

Although he probably will be best remembered for spearheading the Clinton administration’s crackdown on the tobacco industry, Kessler did speed up the FDA review process with some prodding from Congress and industry.

He announced late last year he will resign after six years in office and is to leave in late February. A senior FDA official, Michael Friedman, will temporarily lead the agency while the search continues for a permanent successor.

In addition to the sometimes competing aims of consumer groups and manufacturers, there are factions in Congress who would like to strip the agency of some powers.

A drug industry official said a top priority was renewing a user fee act under which drug makers pay about $200,000 per drug to help the FDA hire experts to review drug efficacy and safety. Pharmaceutical Research and Manufacturers Association spokesman Jeffrey Trewhitt told Reuters the law had worked very well, speeding approvals over the past four years from 30 months to the present 18 months.

But he said the goal set by Congress was six months and “if we want the process to improve, we need the law renewed.”

Trewhitt also called for a sharp reduction in the data required in applications for drug approvals, saying they now can run 100,000 to 200,000 pages. “They are asking for way too much information.”

He said drug makers also wanted better harmonization of approval standards worldwide to make it easer for industrial nations to accept each other’s drug trials and documentation.

The consumer advocacy organization, Public Citizen, said it too would like speedier approvals but it also called for a law to give the FDA more power to enforce its regulations.

The Health Industry Manufacturers Association, the device-makers trade group, said it also wanted faster approval times, adding that a large part of the problem was the many details required for new device applications.

“The rules for the application take most of the time,” James Benson, association senior vice president for technology an regulatory affairs, said.

He said the time required for approval of most devices — those with known risks, such as X-ray equipment — was 90 days and the FDA has done a good job. But, he added, problems arise when an application has to be revised.

“If they (the FDA) feel the application is inadequate, the FDA will ask for more information, so the clock stops and goes back to zero,” Benson said. For high-tech products such as heart valves the required timetable is 180 days, but approvals can take up to 700 days, he added.

Health Research’s director, Sidney Wolfe, agreed that a user fee was needed to speed up medical device reviews. But he also said the FDA should be given power to subpoena documents of a drug or device company it suspects of violating FDA regulations, a power now wielded by other agencies, and be given wider authority to levy penalties for violations.

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