Medical Device Daily

Be careful what you ask for.

That might be the best advice to the medical device industry after what has turned out to be its initial experience with the FDA's device user fee program.

In a report that is likely to come as no great surprise to the medical device industry as a whole, 58 companies in the device space have been surveyed on the value of the user fee system and found it largely wanting and in need of significant repairs.

The impressions and reactions of these companies concerning the program are presented in a new report from The Lewin Group (Falls Church, Virginia), titled “Medical Device Industry Perspectives on MDUFMA.”

Device user fees, of course, were instituted as an attempt to provide assistance to the FDA to support its regulatory approval processes and, it was hoped by the industry, to accelerate the path to product commercialization.

But in listing the various shortcomings of the program, the companies surveyed said that there has been “little evidence of improved return on investment (ROI)” and that “the majority of industry respondents reported not being aware of hard data showing the impact of the program on ROI. This lack of evidence of the program's impact increases concerns about unpredictable increases in user fees.”

That comment comes at a time when the user fee program is positioned to be re-instituted, and provides little support for that action.

And overall, while the Lewin report points to the program's “laudable intent” – and rather significantly, broad support of those purposes from the industry – it finds many more shortcomings than benefits.

Those expressing the benefits of the program tended to echo the program's stated purposes, and some said that the agency's reviewers have tended to call them earlier “and make earlier fixes.” But that was a majority position.

The report says that 70% of the manufacturers who responded to the study “perceived that MDUFMA goals have not resulted in meaningful improvements in either the predictability or timeliness of device review.” And: “Many expressed that review times have, at best, remained 'about the same' compared to pre-MDUFMA experiences, possibly due to agency staffing and other operational constraints.”

It further notes a problem with the program that was identified, early on, even by its chief proponents – inadequate support from Congress, “particularly reflected in insufficient support for [hiring] FDA review staff.”

The industry sees the user fees as a “double tax” and believes that, instead, “the cost of premarket reviews should be included in annual appropriations,” according to the report.

Rather pointedly, it also details four “unintended consequences” of the user fee program:

• That FDA reviewers “'game the system,' intentionally or unintentionally, to meet MDUFMA goals” by stopping the review clock in a variety of ways, such as by issuing formal requests for additional information. This has resulted in delays that are not reflected in the final regulatory timeline.” The report says that at least half of the companies surveyed reported this as a “perception.”

• That there is no method for handling “minimal information requests” as an alternative to formal requests. And the report says that most manufacturers prefer “clock-stopping” pathways for these less formal requests since the more formal pathways tend to result in delays of from 30 to 90 days.

• That the program has resulted in FDA staff giving “greater priority to MDUFMA deadlines than communication with technology sponsors. This may have its most acute effect in the early stages of product development, where understanding the nuances of FDA's requirements for a particular submission . . . is pivotal to key matters.”

• That the prospect of “unpredictable increases in user fees can dampen anticipated ROI of novel products, particularly when such user fees are of a consequential magnitude compared to early product development costs for companies with limited resources or funding streams from other products.”

Some other major shortcomings that the survey found among those responding was a lack of transparency in reporting performance data and explanations for user fee increases and rather widespread “cynicism” concerning the program's resulting in the hiring of new staff to bolster the program.

The report suggests that industry representatives seek, but have had difficulty in getting, sufficient access to information “to help them better understand why user fees continue to escalate steeply and unpredictably, particularly for PMA review,” and that they feel that the agency has had difficulty recruiting people with the necessary expertise to handle reviews, this latter leading to further delays.

Lewin said that the companies surveyed were not picked in a totally random way but were selected according to a “classification matrix,” hence providing a broad overview representative of the industry. A total of 50 companies were first identified for the survey and then eight were added “to ensure the largest possible sample of manufacturer responses and coverage of aspects of the medical device industry.”

Next: Industry reaction and recommendations.