F.D.A. Report Criticizes Oversight of Medical Device Makers

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F.D.A. Report Criticizes Oversight of Medical Device

Makers

By BARRY MEIER

Published: April 1, 2005

The Food and Drug Administration released an internal

report late Wednesday that was critical of its

oversight of medical device makers.

The report is based on a review that took place nearly

two years ago and concluded that the agency had little

idea whether device manufacturers were fulfilling

their obligations to conduct studies on the safety of

products once they were on the market.

Medical specialists serving on F.D.A. advisory panels

often urge the agency to require such studies for

critical medical devices so that doctors will have

more data about their safety and effectiveness.

The F.D.A. review concluded that the agency could not

find evidence that more than half the manufacturers

had performed the required studies. It also found that

the F.D.A's oversight of postmarketing studies of

medical devices was hobbled by sloppy record-keeping.

For 26 of the 45 new products approved between 1998

and 2000, the F.D.A. could find no information to

indicate whether required studies had been done, the

report concluded. Where information could be found, 6

of 11 studies were overdue and 2 had not been started.

In an interview Tuesday, Dr. G. Schultz, the

director of the F.D.A.'s Center for Devices and

Radiological Health, defended the agency's handling of

the report, including its decision not to previously

release the names of companies cited in the

two-year-old study.

He also said that he did not know if the agency had

followed up to see if any device makers had since

supplied missing studies.

The episode may raise questions about the discretion

that F.D.A. officials exercise in determining what

information they choose to make public.

Last week, The New York Times obtained a copy of the

device report in response to a Freedom of Information

Act request. That report, which was termed " final " and

was dated March 18, differs only from the 2003 study

in that it contains agency plans to improve

surveillance of mandated postmarketing studies.

In a December speech in Boston, Dr. Schultz discussed

the report's findings and said he was working to

improve the agency's performance. He said on Tuesday

that he had decided not to publicly disclose the names

of the companies identified in the study because they

represented only a sample of manufacturers who might

have failed to comply with agency rules.

" I don't think it is helpful or fair to point the

finger at the particular companies that were involved

in us doing this exercise, " Dr. Schultz said.

On Tuesday, Dr. Schultz, who took his current position

in August, rejected any suggestion that the F.D.A. had

sat on the report.

The next day, the agency released the report on its

Web site.

The report recommends changes to the agency's

oversight of the mandatory study process, including

using a computerized tracking system.

Several companies cited in the report, including

Boston Scientific, Medtronic and Bausch & Lomb,

maintained that they had done the required studies or

were in the process of doing so, and that any

shortcomings must lie with the agency's administration

of the program.

http://www.nytimes.com/2005/04/01/health/01device.html

Barnaby Feder contributed reporting for this article.