FDA, industry relationship improves since 1997

The Food and Drug Administration has significantly improved its relationship with the pharmaceutical and medical device industries, but a recent survey shows that the agency still needs to work to eliminate unnecessary delays in approving new products and devices.

The survey, jointly conducted by the University of California at San Diego's Technology and Entrepreneurship Program, and New York-based PricewaterhouseCoopers, found that delays in approvals are frequently related to inadequate technical expertise of FDA reviewers. Survey respondents also noted that there is high turnover among the agency's reviewers, which also contributes to delays.

Don Grimm, director of the "Improving America's Health" survey, said: "The study shows that there is still work to do to reduce unnecessary approval delays so that patients can benefit from worthy medicines and devices."

"Improving America's Health" is a bi-annual survey that was first conducted in 1995 to identify and track delays in the FDA approval process. Respondents were U.S. companies that had a drug device or biologic in clinical trials under agency supervision between January 1, 1998 and June 30, 1999. This year's survey is the first to be conducted since the enactment of the FDA Modernization Act of 1997.

Strengthened communications

The survey cites improvement in the overall communication between the FDA and the sponsoring companies, particularly in the areas of response time for inquiries and ease of contact. Overall, 48% of the respondents categorized their communications with the agency as "excellent," in comparison to 41% in 1997 and 34% in 1995. Additionally, 64% responded that it was easy or very easy to contact the reviewers – an increase from 52% in 1995.

More room for improvement

In addition to the turnover of agency personnel, respondents indicated that there are several other factors that continue to delay the approval process unnecessarily, including unclear data requests from the FDA. An increasing number of companies surveyed (42% in 1999 versus 27% in 1997) indicated that the turnover of key reviewers impeded the approval process. Twenty-seven percent of sponsors indicated that the lack of technical expertise on the part of a reviewer unduly delayed the approval process, up from 21% in 1997 and 18% in 1995. PR