James R. Ravitz, James H. Hartten06.05.07
New MDUFMA Is a Positive Step Forward
James R. Ravitz
James H. Hartten
James R. Ravitz |
The significant changes from MDUFMA signal that all the key stakeholders have a better understanding of how the user fee program can benefit patients while also encouraging product development and innovation. MDUFMA II addresses many of the outstanding issues that MDUFMA I created, reduces application fees and promises to reduce application review times. Overall, MDUFMA II is good for the deviceindustry, but some don’t believe the proposed legislation goes far
James H. Hartten |
Expansion of User Fees
The objective in reauthorizing MDUFMA was to set user fees at cost levels that would stabilize the device review program financially, while also improving the device pre-market review process. To achieve its first objective, the FDA proposed to increase user fees by 8.5% annually during the five-year reauthorization period. One important aspect involves adding new user fees that are expected to generate roughly 50% of the total annual user fee revenue beginning with FY 2008. These new fees, which would increase annually, include an annual device establishment registration fee, an annual fee for filing periodic reports, a fee for 30-day notices and a fee for a request for classification information under section 513(g) of the Food, Drug and Cosmetic Act.
The establishment registration fee would be paid once each year by each device manufacturer, single-use reprocessor and specification developer. The fee is proposed to start at $1,706 in FY 2008. A firm would not be considered legally registered without payment of this fee. The proposed annual fee for filing periodic reports would start at $6,475 in FY 2008. The establishment registration and annual periodic report fees are expected to generate approximately $24.3 million, or 50% of total fee revenues, next year. However, imposition of these fees would allow the FDA to lower and stabilize the user fees that firms must pay to submit device applications. Indeed, initial application fees for FY 2008 would be significantly lower than similar fees charged in FY 2007. The proposed fee for a panel-track supplement would be charged at 75% of the rate for a pre-market approval application (PMA), rather than at 100%, as was the case from FY 2003 through FY 2007. Further, the fee for a 180-day PMA supplement is proposed at 15% of the PMA fee, rather than at 21.5% of the PMA fee, as was the case in those years.
Small businesses also would see relief under MDUFMA II, as their user fees would be reduced for PMA applications, panel-track PMA applications, biologic license application efficacy supplements, 180-day PMA supplements, real-time PMA supplements and annual reports—from between 38% to 25% of the normal fee. The FDA also is proposing to reduce the rates for small businesses for 30-day notices, 510(k)s and 513(g) requests for classification information from 80% to 50% of the normal fee.
Improving the Process
The proposal also intends to improve device application review times by implementing the following measures:
• Providing staff with additional scientific and regulatory training, and adding experienced staff to handle increasingly complex device reviews. The FDA also hopes to expand its use, when necessary, of outside experts and make better use of information technology to track and manage the device review process
• Adding the following target benchmarks for reaching a final decision on applications under review: (a) reaching a final decision for 60% of non-expedited PMAs and panel-track PMA supplements within 180 days, and for 90% within 295 days; (b) reaching a final decision for 50% of expedited PMAs and expedited panel-track PMA supplements within 180 days and for 90% within 280 days; (c) reaching a decision for 90% of 510(k)s within 90 days and for 98% within 150 days; (d) reaching a decision for 85% of 180-day PMA supplements within 180 days and for 95% within 210 days; and (e) reaching a decision for 80% of real-time PMA supplements within 60 days and for 90% within 90 days. The agency also proposes at least maintaining current performance for reviews involving IDEs and 30-day notices
• Using an “interactive” review process to encourage informal communication—using all available forms of communication—between the FDA and sponsors to facilitate timely completion of reviews.
• Continuing to develop guidance documents to the extent possible without adversely impacting the review timeliness for submissions subject to user fees
• Issuing new guidance addressing diagnostic imaging devices that are sometimes used concurrently with diagnostic drug and biological products to better facilitate the timely review of these products
• Clarifying the regulatory requirements for in vitro diagnostics by issuing revised guidance on clinical trials involving de-identified leftover specimens, clinical trial design issues for molecular diagnostic tests, migration studies and testing for herpes simplex virus, enterovirus and influenza
• Improving efforts to schedule informal and formal meetings between the agency and device applicants, both before and during the review process
• Issuing quarterly progress reports
Is It All Positive?
Admittedly, MDUFMA II does not have many drawbacks. Some industry members have suggested that reducing application review times and redistributing the user fee structure are only moderately helpful given that most of the time and financial investment for new technology occur at the pre-IDE phase. These companies argue that a more tangible effect could be attained if pre-IDE issues were more specifically addressed.
This position has some merit, because the pre-IDE process can be long, expensive and sometimes contentious with the FDA in determining clinical data endpoints. While MDUFMA II does not specifically address this broad issue, some pre-IDE issues may be resolved by issuing more extensive guidance documents that provide a clearer picture on device-specific data requirements. Indeed, MDUFMA II contemplates the issuance of more extensive guidance documents on this point, and these documents could alleviate some of the burdens faced by companies at the pre-IDE stage.
However, many pre-IDE issues are case specific, so it may be ambitious at this point to believe that sweeping changes could be made. Nevertheless, this is an issue on which the device industry should focus for the next round of discussions.
What often goes unnoticed about MDUFMA II is that the device industry now has greater influence in shaping the FDA’s regulation of the device review process. A good example of this is the prominent roles that the Medical Device Manufacturers Association and AdvaMed took in negotiating the scope of the legislation. Still, the FDA and agency purists have complained that this is precisely one of the greatest drawbacks of collecting user fees—if the FDA derives its funding from the industry, then how can the agency effectively regulate devices and ensure their safety and efficacy?
In reality, the FDA’s mandate has not changed, so there should be no practical effect on device safety or efficacy. If anything, changing the FDA’s source of funding will affect both the industry and the agency positively because the FDA may be relieved of its current financial restrictions. Now, given that the FDA’s funding is derived in large part from the industry itself, the industry is in an unprecedented position to improve not only the processes by which devices are regulated, but also the overall health outcome of patients who need devices.