MDUFMA, the user fee program that was intended to help the FDA speed regulatory reviews, has been in place for five years and is set for morphing into MDUFMA2.
It was a program asked for by the industry. It was pushed forward by the Advanced Medical Technology Association (AdvaMed; Washington), under the leadership of its former staff executive, Pamela Bailey, with the intent of speeding approvals.
In contrast, the Medical Device Manufacturer's Association (Washington) - AdvaMed's counterpart tending to represent the smaller, entrepreneurial and development-stage sector of the device industry - resisted it initially, as it always had in the past. But it could decipher the proverbial writing on the legislative wall and ultimately acceded to the program when a two-tiered schedule of fees was developed, a lower amount set for smaller companies with fewer resources.
But over the course of "MDUFMA1," the industry's companies, large as well as small, have never been completely satisfied with the results, seeing no great improvement in the speed of regulatory approvals or an overall improvement in agency expertise. In a phrase, not enough return on investment.
That is the conclusion that can be drawn from the just-released report from The Lewin Group (Falls Church, Virginia), "Medical Device Industry Perspectives on MDUFMA." Concerns from that report were detailed in MDD yesterday.
But rather than just complaining about the user fee program's shortcomings, the industry has offered a variety of recommendations for MDUFMA2, as presented in the Lewin report, as follows:
• Rather than tracking only the mandated approval timeline, "many industry respondents," according to the report, suggested "monitoring and tracking cumulative FDA review time [emphasis added] or time to market" and development "of an expedited review process for truly novel of 'breakthrough' technologies." This was recommended despite a reluctance to add new "cycle" goals but was seen as "the single most important new performance goal for consideration in the new MDUFMA legislation."
Put another way, the suggested cycle time would include the entire process of review, from initial filing to final approval (or non-approval), including the days of "clock-stopped" periods which the companies say are being used by FDA staff as a way to "game" the system to meet the mandated time frames.
Overall, these firms said there is a need for the agency to develop "greater flexibility in providing . . . earlier access and quality communication" to reduce "burdensome delays."
• The surveyed companies said that the FDA "absolutely should not divert MDUFMA user fees to subsidize other agency activities, other than to improve the timeliness and quality of premarket device reviews," with the clear implication that this is agency practice and has been patently overlooked by Congress.
• Reacting to a lack of "transparency" in the program and difficulties in understanding current fee systems formulas or those in the future, the firms are calling for "access to consistently-defined, reliable performance data" and "more timely and detailed information about user fee increases, so that firms can identify as early as possible the implications for product planning."
• Given the companies' perception of insufficient review staff and staff with insufficient expertise - at the same time granting that a number of agency staff are "superb" at their jobs - respondents recommended improved training programs and improved oversight of staff. And they recommended "hiring staff with hands-on experience and establishing a more structured skills development approach that include ongoing staff training and opportunities for site visits that enable review staff to gain first-hand exposure to new and emerging technologies."
Indubitably, we agree - and the FDA's just as indubitably will say that it will need additional funding to provide these programs and more staff to fill the gaps when reviewers are out of the office making on-site visits. (And, MDD might add, it's exactly the difficulty that office-bound journalists can well relate to.)
• Noting longer timelines in developing product and regulatory guidances, the companies are calling for the agency to "redouble its efforts to complete guidance documents that have been in draft form for an extended period of time and enable more efficient drafting, review and timely release of guidance documents."
• Praising the work of the relatively new Office of Combination Products, the respondents recommended increasing staff in that office and strengthening "its authority relative to the FDA centers and its ability to coordinate center involvement in premarket reviews of combination products."
Overall, the Lewin report takes pains to state that many of the survey respondents were willing to praise agency staff and report improvements in the regulatory process. But a clear overlying theme is that improved communication is key - and, we might note, that improved communication usually depends on individual personalities, not legislative mandate.
Thus, while the FDA has passed beyond its adversarial stance of the late '80s and early '90s, some of the survey respondents still reported a "we-against-them" attitude among some staffers that hindered the approval process.
The report writers said the companies surveyed emphasized the need for clear and ready feedback "in an atmosphere of mutual respect." But they said that "manufacturers emphasized strongly that FDA staff orientation toward meeting MDUFMA review goals has worked against the willingness of staff to meet early and often with manufacturers to discuss and clarify clinical evidence requirements and other concerns."
And the report cites a frequent example of inconsistent communication: companies receiving direction at an early meeting with one reviewer, then having a different reviewer request additional data, producing a "bleed over" of new requirements and "creep" in evidence requirements.