CDRH claims progress in device-review timesTwo bills that would have reformed the operations of the Foodand Drug Administration died after the 104th Congress adjournedthis month without acting on the legislation. Proponents of changingthe way
Two bills that would have reformed the operations of the Foodand Drug Administration died after the 104th Congress adjournedthis month without acting on the legislation. Proponents of changingthe way the powerful federal agency does business will have towait until the 105th Congress is convened next January beforeresuming the fight.
The reform bills were S. 1477, sponsored by Sen. Nancy Kassebaum(R-KS), and H.R. 3201, introduced by Rep. Joe Barton (R-TX). Thecenterpieces of both bills were sections that would have mandatedthird-party review of medical devices.
Hopes were high that some kind of FDA reform legislation couldbe passed in the last congressional session. There has been widespreaddissatisfaction among drug and device companies with the FDA'sregulation of the healthcare industry, and the election of a Republicanmajority in Congress in 1994 gave heart to FDA reformers.
Progress on the bills proceeded slowly, however, due in partto opposition from Sen. Edward Kennedy (D-MA). FDA reform proponentsmounted a last-ditch effort this summer to overcome his oppositionand push through the legislation (SCAN 7/17/96).
The effort ultimately failed. Kassebaum's bill got out of committeebut didn't make it to the floor of the Senate. Meanwhile, H.R.3201 never even made it out of committee, and both bills diedwhen Congress adjourned earlier this month.
In the end, advocates of FDA reform were probably expectingtoo much from the Republican Congress, according to James Benson,senior vice president of the Health Industry Manufacturers Associationin Washington, DC.
"Expectations were probably higher than reality,"Benson said. "The fact that it took a long time to get draftbills or committee bills out gave us very limited time to makereform happen."
Prospects for FDA reform next year depend on what happens inthe November elections, Benson said. If the Republicans maintaincontrol of Congress, there is a good chance the issue will berevisited; if not, the healthcare industry's best chance to reformthe FDA through legislative action has probably passed.
Indeed, the FDA last week released data on its device-reviewtimes for fiscal 1996 that may blunt any further reform efforts.The agency said its Center for Devices and Radiological Health(CDRH) has made dramatic improvements in shortening review timessince it began an internal reform initiative several years ago.
The average review time for 510(k) devices was 110 days, downfrom 137 days in fiscal 1995 and sharply lower than the peak averagereview time of 184 days in fiscal 1994. The backlog of 510(k)applications under review for more than 90 days -- a major problemseveral years ago -- is now totally eliminated.
The CDRH in fiscal 1996 approved 43 premarket approval applications,which are more rigorous than 510(k) submissions. That figure is16 more than in fiscal 1995. The average review time for PMAswas 568 days, compared with 606 days in 1995.