From the Editors
One day in April, FDA posted on its Web site a report it had commissioned about industry's perspective on the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). But the report, which was written by The Lewin Group and contained a fair amount of criticism, was soon taken down and at press time had not been put back up. (We have a printout from when it was first posted.)
Whether this had to do with technical glitches, proprietary concerns, shame at the negative portion of the content, or something else, we don't know. But the analysis and conclusions contain a lot of constructive criticism that should be heeded as the agency, industry, and Congress gear up to reauthorize MDUFMA in 2007.
As far as basic principles go, the news is good. Nearly all manufacturers surveyed think FDA is doing a good job and believe that the purpose and goals of MDUFMA are worth supporting. FDA guidances received praise fo r helping firms craft better applications. The Office of Combination Products (OCP), which was created by MDUFMA, drew accolades as well.
But what is troubling is that almost 70% of respondents do not perceive that MDUFMA has resulted in significant improvements in the predictability and timeliness of device reviews. And most do not think that user fees have produced an adequate return on investment.
What industry wants, the report states, is the measurement of total product review time. This, and not cycle goals or decision goals, is believed to be the metric that can best prove whether MDUFMA is meeting its intended purpose.
By putting so much focus on the milestones that occur at the end of the regulatory submission process, CDRH has sacrificed its ability to communicate with industry early and often, according to the report. Industry also perceives that reviewers have resorted to delaying tactics to stop the clock on review times and have been less willing to resolve minor questions informally. “Industry representatives believe that these unintended consequences precipitate substantial and avoidable delays and inefficiencies in the review process, contributing to greater overall resource requirements for product development,” the report states.
What can be done about this? Tracking cumulative FDA review time or total time to market is the industry suggestion with the most priority, according to the report. Others include the following:
• Do not divert user fees to subsidize CDRH activities that don't improve the timeliness and quality of premarket reviews.
• Allow stopping the clock even when a reviewer needs only minimal additional information. This would encourage more informal communication.
• Be more flexible in scheduling early meetings with industry. This could save time later on in the process.
• Chart the data so that they clearly link the investment from user fees to CDRH performance improvement.
• Provide more timely and detailed information about user-fee increases. This will help firms with product planning.
• Improve training programs for reviewers and hire staff with more hands-on experience. A more-structured skills-development approach might be needed.
• Draft and review guidance documents more quickly and efficiently.
• Increase the staff of OCP, strengthen its authority, and enhance its ability to coordinate among the centers.
FDA and industry have used great teamwork to make MDUFMA work so far. A good portion of its success in the future may be out of its hands—if Congress won't appropriate the funds it promises, the program simply is not going to achieve most of its intended purposes. But the other portion depends on the same kind of teamwork shown so far, or better. The Lewin Group report reveals some industry ideas that will enhance teamwork. FDA and Congress need to consider them very seriously.
Erik Swain for the Editors