Complex Relationship Between FDA and Life Sciences

Approvals, politics, and user fees are among the issues that make for an uneasy relationship between the US Food and Drug Administration and the life sciences industry, according to findings from a recent PricewaterhouseCoopers (PwC) survey of the industry. This survey, “Improving America’s Health V,” the fifth such survey performed since 1995, found that although relations between the FDA and the life sciences industry have improved over time, there is still much progress to be made.

The survey results found problems with the FDA’s approval process. Thirty percent of survey respondents saw no improvements in the last two years, and more than half (58%) agreed that politics had too much influence in the FDA approval process.

The survey touched on the hot-button issue of user fees, which will expire in 2012 unless Congress renews them. Survey respondents felt that the user fees do not accelerate the review process, are excessive, and can cause a conflict of interest.

With the recent changes to healthcare law, FDA has been granted new responsibilities, but these are choking the already resource-constrained agency, said respondents, who also felt the lack of resources prevents the agency from keeping up with advances in technology. Survey respondents also feel that FDA is behind the rapid changes in the life sciences market, in areas such as personalized medicine and biomarker development.

Communication problems on both sides also plague the relationship. Respondents were frustrated by delays in scheduling presubmission and end-of-phase meetings. Industry respondents feel that FDA should improve feedback during the development process. Respondents also said they were generally unaware of major FDA initiatives.

Greater collaboration between FDA and the industry would allow drugmakers to focus on outcomes-driven medicine, rather than on FDA’s current approach to drug approvals, respondents said. Most agreed that the approval process should be replaced with a limited-launch, living-license process, which is based on gradual accumulation of data over time and incremental approvals based on smaller populations.

PwC enlisted the help of industry trade associations BIOCOM in California and MassBio in Massachusetts to recruit this year’s survey respondents. A total of 50 companies responded, and responses were limited to one per company. The responders included CEOs, COOs, VPs, directors of regulatory affairs and quality, and other executive staff.

The full survey can be found on the PwC web site http://www.pwc.com/us/en/health-industries/publications/improving-americas-health-v.jhtml

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