FDA Reform Talks Drag On

Conferees on legislation to overhaul operations of the FDA are unlikely to complete work on the bill before next week, sources predicted Wednesday.

That leaves up in the air the reauthorization of the popular Prescription Drug User Fee program, which is included in the broader FDA reform measure.

Staff and members involved in the ongoing negotiations stressed that no single issue is holding up the proceedings, and remained confident the measure would be finished and signed by President Clinton before Congress adjourns for the year.

"I'd say we're about 60 percent done," said one House GOP conferee, while Sen. Bill Frist, R-Tenn., also a conferee, said he only knew of "about three issues" that would require discussions among the principals.

However, members have not yet met as a group, with all the work still at the staff level.

Sources said that while progress has been brisk on the prescription drug sections of the bill, the medical device provisions remain a potential trouble spot.

It remains unclear whether the Senate will embrace a compromise reached between House Republicans and Democrats over what power the FDA will have to review devices for uses not specified by the manufacturer.

Under the House-passed compromise, the FDA would have to rely on the manufacturers' stated use of a device unless the agency, after consulting with the manufacturer, finds "a reasonable likelihood that the device will be used for an intended use not identified in the proposed labeling of the device," and that "such use could cause harm."

Meanwhile, a group of senators not on the conference is urging Senate conferees to include in the bill a House provision that would require drugmakers to provide advance notice before discontinuing production of drugs "whose sudden absence would result in death or serious debilitating injury to patients who rely on these products for survival."

The letter from Sens. John Chafee, R-R.I., Olympia Snowe, R- Maine, Richard Durbin, D-Ill., and Paul Wellstone, D-Minn., noted a situation last year when a medication to treat epilepsy in babies was halted without notice, leaving patients at risk of mental retardation or death.

"Notice gives patients time to look for an alternative and the FDA time to find a solution if a health crisis is likely," the letter said.