Originally Published MDDI June 2002
NEWS & ANALYSIS
Wee-hours efforts (2:30 a.m., actually) by AdvaMed, congressional staffers, and FDA on May 20 to attach medical device user fees—now called medical technology application fees—to bioterrorism legislation speeding through Congress failed at the last minute and now await revival efforts this summer. The measure was fiercely opposed by lobbyists for the Medical Device Manufacturers Association, which contended that the proposed fees could not be afforded by smaller manufacturers.
"Whenever government ups the ante, smaller players have to drop out, leaving the field to larger companies," said MDMA chairman Paul Touhey. From FDA's viewpoint, this evidence of a lack of industry consensus was enough to cause it to back away from its hasty and informal pact with AdvaMed. Last-minute controversies about adding a third-party inspections provision from the Greenwood-Eshoo bill also caused the matter to be dropped from the bioterrorism bill.
FDA and AdvaMed came to terms on a legislative program modeled on the 10-year-old Prescription Drug User Fee Act (PDUFA), which has been hailed as a success in reducing review times and establishing predictability in the drug review process. On May 20, AdvaMed's board approved the Medical Technology Enhancement Act to add about $225 million through user fees and increased appropriations into CDRH's review operations over a five-year period.
Proposed Year-One Fees
|PMAs, panel-track supplements, BLAs, BLA efficacy supplements||
|PMA, BLA supplements||
|Real-time PMA supplements||
|Special PMA supplements||
|30-day PMA supplements||
|User fee legislation's proposed fees.|
In a statement to AdvaMed members, Pamela Bailey said the AdvaMed board made this decision because it "recognizes that this step must be taken to address the serious resource challenges faced by FDA's device review program." Commenting on the haste of AdvaMed's announcement, Bailey said, "Congress's timetable on bioterrorism legislation required us to move quickly to seize this unique opportunity."
In a media briefing, AdvaMed said $40 million would be injected into the Center's device-review activities in the first year ($25 million from user fees and $15 million from an increase in appropriations), and performance goals for review decisions and review cycles would be established. Under the proposed measure, PMAs would be charged $125,000 per submission; PMA supplements, $25,000; real-time PMA supplement reviews, $10,000; and 510(k)s, $2500. Key details of the proposal include:
Under the agreement, CDRH would be required to reach a decision on 50% of all PMA applications within 180 days by year five (current performance is 208 days). The center would also provide a 30-day processing goal on responses to 90% of CDRH-issued approvable letters.
For 510(k)s, the agreement sought a 30% improvement by year five in issuing "substantially equivalent" or "not substantially equivalent" decisions, down from the current 125 FDA days to 90 days for 80% of submissions. Firms using a third-party reviewer would be granted a fee waiver.
The program would also impact CDRH-reviewed biologic licensing applications (BLA). By year five, 90% of BLA and BLA efficacy supplements should be acted on within 10 months. In addition, 90% of BLA manufacturing supplements would be reviewed and acted on in four months.
In a May 22 press release, AdvaMed blamed the effort's failure on Congress's "tight timetable" for the bioterrorism bill. Although MDMA opposition caused FDA to rethink the bill, AdvaMed and congressional backers have not given up on it, and are expected to reintroduce it before the July 4 congressional break. "Congress should act promptly to pass these measures," Bailey said, "to ensure FDA can keep up with the increasingly rapid pace of medical innovation."
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