The Food and Drug Administration's Center for Devices and RadiologicalHealth has again become a lightning rod for controversy. Concernabout the slow pace of device approval at the center promptedRep. John D. Dingell (D-MI) to fire off a letter to FDA
The Food and Drug Administration's Center for Devices and RadiologicalHealth has again become a lightning rod for controversy. Concernabout the slow pace of device approval at the center promptedRep. John D. Dingell (D-MI) to fire off a letter to FDA CommissionerDavid A. Kessler last month detailing the adverse effects of approvalgridlock on U.S. device makers.
The letter represented a shift in Dingell's position towarda more industry-oriented perspective of the device review process.But the letter may have complicated matters by causing a publicspat with the FDA that aggravated an already tense environmentbetween Dingell's oversight subcommittee and the agency.
Earlier this year, Dingell presided over hearings in the Houseof Representatives subcommittee on oversight and investigationthat described serious problems at the CDRH (SCAN 6/17/92). Thecenter was characterized as disorganized, confused and biasedin favor of industry.
The situation at the CDRH has deteriorated since then, accordingto the Dingell letter. The number of device approvals has slowedto a snail's pace, and product reviewers are refusing to communicatewith industry.
"The Center for Devices appears to be paralyzed,"Dingell said. "Approvals are virtually nonexistent...nothingis happening despite the fact that at least some pending approvalsoffer the only real hope for people in need of lifesaving devices."
Dingell went on to describe the situation as one of "crisisproportions." He urged the FDA to develop a plan of actionfor timely device approvals and to reestablish lines of communicationbetween the CDRH and industry.
Industry observers, however, say that Dingell's oversight effortsmay have contributed to the slowdown. Congressional scrutiny inthe wake of fiascoes such as the generic drug controversy hasresulted in reviewers who are afraid to act for fear of beingsecond-guessed, according to Frank E. Samuel of Government StrategyAssociates, a Washington, DC, consulting firm.
"The effect of that kind of oversight and criticism--notjust from Dingell's committee but from other oversight bodies--hasbeen cumulative and unrelieved," Samuel said. "The effecton (the center's) performance has been clear in the statistics."
Those statistics indicate that only nine devices have beengranted premarket approval during the first six months of 1992,less than half the rate during 1991 and one-third of the 47 devicesapproved in 1990, according to a Department of Health and HumanServices memo.
Concern over the possible link between Dingell's review andthe device approval slowdown led to a meeting in August betweensubcommittee staffers and the Minnesota medical trade group MedicalAlley. The meeting was productive in that it prompted the subcommitteeto look at the device review issue not only from a public healthperspective but also from the device industry's point of view.Many of Medical Alley's concerns were included in Dingell's letterto Kessler.
"(Manufacturers) are extremely frustrated. I think theyare very nervous about the almost gridlock forming at the center,"said Thomas L. Meskan, president of Medical Alley. "Devicecompanies generally don't have the staying power that pharmaceuticalcompanies do. For a lot of them, (the review process) is a make-or-breaksituation."
IN RESPONSE TO DINGELL'S LETTER, Kessler asserted that the overallnumber of CDRH premarket approval application actions--includingapprovals, disapprovals, deficiency letters and filing decisions--hasremained fairly constant, at 350 a year for the past five years.
To improve communication with industry, the agency is workingon a system for providing progress reports to manufacturers ondevice application statuses, Kessler said. Also, a new telephoneprocedure is being developed to allow FDA staffers to respondmore quickly to manufacturer inquiries. One complaint of manufacturersat the Medical Alley meeting was that a new FDA policy prohibitsreviewers from returning industry phone calls, according to Meskan.
Although Kessler was responsive to Dingell's concerns, at leastone other FDA official was not as amenable. An article publishedSept. 10 in the Washington Post described the FDA as being harriedby the representative's "Dingellgrams," of which 175have been sent to the agency since January 1991. An unnamed "seniorFDA official" said that staff at the agency was confusedby Dingell's apparent change in position toward device review.
That prompted Dingell to dispatch his 176th missive to theFDA, restating his concerns and hinting that the unnamed FDA officialcould "no longer be entrusted with significant responsibility."
"We have basically gotten into a pissing contest,"a Dingell staffer said of the exchange.
As the subcommittee and the FDA continue to jockey over reformof the CDRH, device manufacturers are hoping that the recriminationswill not destroy relations between two of the parties necessaryto break the gridlock of device approvals.
"There's a need for industry, the FDA and the subcommitteeto all sit down together and to positively and constructivelyaddress these things at one time and one place, rather than playingthe `he said, she said' kind of thing," Meskan said.