Is Industry Receiving Full User Fee Benefits? “No,” According to a PricewaterhouseCoopers/BIOCOM Report, But Progress in Other Areas is Being MadeMay 28, 2007
In a recently-released report on the pharmaceutical, biotech, and medical device industries’ relationship with FDA, a significant number of representatives surveyed responded that user fees have not succeeded in decreasing approval times. The report, “Improving America’s Health IV: A Survey of the Working Relationship between the Life Sciences Industry and the FDA,” summarizes the results of a 2006 survey of industry conducted by PricewaterhouseCoopers and BIOCOM, a Southern California regional trade association. The report is the fourth in a series. Previous reports were based on surveys conducted in 1995, 1997 and 1999.
Of the 66 companies that responded to the survey, approximately one-third of pharmaceutical and biologic companies, and nearly one-half of medical device companies indicated that user fees have not resulted in decreased approval times for products under consideration by FDA. The report notes that this finding may become significant as Congress considers whether to reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee and Modernization Act. The report suggests that FDA may need “to explain how staff increases speed up reviews,” and that “[g]reater transparency may be needed about how the user fees are being employed, especially by [the Center for Biologic Evaluation and Research].” The report urges consideration of “a structural review of the product approval process resourcing model . . . to help ensure a proper balance of resources.”
In addition, among the “most worrisome findings” of the survey is that approximately half of the responding companies reported that goal timeframes caused FDA to reject products because reviewers have not been able to resolve questions within those timeframes. The report suggests that the availability of additional reviewers may help to alleviate this problem.
The news is not all bad, however. The report notes that “[i]n the nearly ten years since the passage of [the FDA Modernization Act], both FDA and life sciences companies have met somewhere in the middle, both making great strides to improve communication and effectiveness of their working relationship.” Indeed, a majority of surveyed companies “agreed that FDA promptly facilitated requests for clarification from the reviewers, the Agency contact was extremely knowledgeable about their submission status and promptly responded to requests.” With respect to FDA’s risk mitigation and product lifecycle management initiatives, 88% of surveyed companies “agreed that new FDA guidance . . . has enhanced their comprehension of submission requirements,” and a significant majority of respondents “agreed that FDA is making better decisions because of these guidance tools.”