An Oct. 21 meeting between representatives of the medical device and diagnostics industries and the FDA over user fees featured a "robust exchange of different ideas" that advanced the talks over renewing the Medical Device User Fee & Modernization Act, according to minutes of the meeting.
The meeting, which is the latest in a series convened to hash out what med-tech can expect in return for the fees it pays to the agency, involved a baker’s dozen representatives of the agency and nine people from various industry groups and firms, including Abbott (NYSE:ABT), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Philips (NYSE:PHG), Quest Diagnostics (NYSE:DGX) and LabCorp (NYSE:LH).
"Both FDA and industry acknowledged that the robust exchange of different ideas during the meeting and over the past several weeks has accelerated progress toward resolving differences in the qualitative and quantitative performance goal areas," according to the minutes. "FDA and Industry agreed to continue to work toward resolving these differences in the next several days so that financial resources can be discussed at the next meeting."
For its part, the federal watchdog agency said it tried to focus on issues the industry flagged as priorities, aiming to allocate more resources to those areas that to "propose goals that did not provide value commensurate with the incremental increase in resources that would be required to meet them."
"For example, FDA understood from industry that timely decisions on marketing applications are most important. In its proposal, FDA therefore focused less priority on improvements in the timely review of PMA modules in favor of improvements to timely review of marketing applications," according to the minutes.
FDA also suggested shifting some personnel to reduce the ratio of reviewers to supervisors, saying it lacks the resources to lower that ratio otherwise.
"Shifting resources in this way will have the positive impact on improving consistency and predictability, but will negatively impact performance since there will be less staff doing reviews," according to the minutes.
That idea was met with "displeasure in what was perceived as FDA’s assumption that industry would pay for the publicly announced reorganization plan."
"FDA clarified that a reorganization of CDRH has been proposed publicly as a potential means of addressing concerns regarding consistency, predictability, and transparency," according to the meeting’s minutes. "FDA has not committed to moving forward with this proposal due to the current lack of resources to implement the plan, but acknowledged that the current organizational structure needs to change in order to effectively carry out its public health mission."
The agency agreed to use some of the cash supplied by industry to boost its guidance document operation and proposed a separate performance goal for 510(k) clearance applications for products that combine drug or biotech compounds and medical devices. Noting the complexity involved in reviewing such combination devices, the FDA said setting a separate goal would "mitigate the unintended consequence of negative decisions when there is not sufficient time to work through outstanding drug issues."
Industry was not impressed, citing the existence of an FDA center mandated to "ensure timely and effective pre-market reviews by overseeing the timeliness of and coordinating reviews involving more than one agency center" and asking the agency to weed out combination device data from historical 510(k) data if the separate goal goes into place.