Starting in 1995, PricewaterhouseCoopers (PwC) has surveyed the life sciences industry on its working relationship with the US Food and Drug Administration (FDA), its chief regulatory agency. This year’s fifth survey produced mixed results for industry and the FDA. See the PwC press release for more information.
Among the six key findings described in the Executive Summary, four seem especially important for regulatory writers (1):
- Despite complex scientific, economic and political changes, the relationship has improved; but problems remain. 78% of respondents said that the agency’s guidance documents have increased industry’s understanding of FDA’s expectations. I know from first-hand experience that this has been a major initiative by the FDA over the past 3-4 years. FDA personnel regularly speak at events sponsored by the Drug Industry Association (DIA) and Regulatory Affairs Professionals Society (RAPS), two of the largest professional organizations for regulatory writers and regulatory personnel. However, problems persist as 30% of respondents saw no change in the agency’s approval process over the last two years, and more than 60% said that the FDA changed its position during their review. Working with a number of biopharma customers at TRA360, this is a consistent issue and one the agency needs to address. Better training, oversight, and assessment seem like valuable areas for improvement.
- FDA approval process lags in both scientific and technological advances. Industry feels that the agency is not keeping up with technology, something we hear from our customers, vendors, and regulatory consultants all the time. Part of this is the usual industry-government divide, but in my opinion, both parties need to work harder to bridge the gap. Joint initiatives have been underway for years, but more creative solutions are needed.
- More frequent, open and clear communications could benefit both sides. After 10+ years as a regulatory professional, this is no real surprise. Industry needs to do a better job at scheduling meetings with FDA—pre-submission and end-of-phase—and FDA needs to be more proactive in requesting them. And FDA needs to work hard to standardize submission requirements throughout the development process, especially in the endgame when delays or failures are more expensive.
- Opportunities abound to improve America’s health. Increased collaboration between industry and the FDA are essential here, especially with regard to the agency’s high stakes, all-or-nothing approach to drug approval. Based on my experience, regulatory professionals can be key players in successful outcomes here.
Overall, I found PwC’s Improving America’s Health V an insightful survey, rich with important data for biotech, pharma, and medical device companies, regulatory professionals, regulatory writers, medical writers, and medical communicators. The complete findings of the study and a podcast on the report are available for download at: http://www.pwc.com/us/fdasurvey.
(1) Improving America’s Health V, http://bit.ly/ekbSxf, page 3.