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Life sciences community reports on FDA approval progress

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A study released Wednesday by Biocom and PricewaterhouseCoopers LLP revealed that although the U.S. Food and Drug Administration has made strides with improved guidance, expectations and approvals, the industry remains concerned about a number of regulatory challenges.

The fourth edition of a medical device and life science industry study, called “Improving America’s Health,” outlined a series of issues Biocom said require resolution to improve product review delays and shorten the approval process.

The law firm Latham & Watkins provided underwriting assistance for the report.

“This study is very important because the working relationship between the life science industry and the FDA has a critical bearing on the health of Americans,” said Joseph Panetta, president and CEO of Biocom, a local trade organization comprised of life sciences community members. “The good news is that these relationships have greatly improved since enactment of the Food and Drug Administration Modernization Act of 1997.”

Despite what it called significant progress, the report outlined how the industry and the FDA need to work together to overcome challenges.

A minority of companies surveyed indicated that the FDA changed its position during the review of product submissions, allegedly for no discernable scientific reason.

While the number was small, the impact of the FDA changing its position can be significant on a company’s development program.

Faster turnaround times were most frequently cited (by 61 percent of all respondents) as the area in which further FDA improvement is most needed.

FDA staffing shortages and turnover remain the biggest ongoing issue for life science firms. Six in 10 companies surveyed agreed or strongly agreed that FDA personnel changes resulted in a break of continuity in at least one of their reviews.

The industry believes that FDA reviewers still cannot keep pace with review queues. More than half of all companies responding indicated that goal timeframes have caused FDA to reject products simply because reviewers run out of time to resolve issues.

Congress authorized companies to pay user fees to remedy FDA’s chronic shortage of resources and accelerate product approval times. However, one-third of life science firms surveyed, including half of medical device firms, reported that user fees have not decreased product approval times.

This finding could prove significant as Congress debates renewal of the Prescription Drug User Fee Act (PDUFA), which expires this year.

Life science companies appear to not be taking full advantage of better communication and guidance from the FDA.

One-half of life science firms overall, and nearly two-thirds of medical device companies surveyed, admitted that they are not incorporating the agency’s feedback into their product development progress.

In addition, a significant number said they do not participate in stage-review meetings, especially later in the product approval process.

The FDA Critical Path Initiative was designed to modernize the scientific process through which products are developed.

A majority of life science companies (58 percent) said they are familiar with the Critical Path Initiative and a majority (64 percent) agrees with its importance, but only 41 percent agreed it is focused on the right issues.

The FDA is providing better guidance and clearer expectations. Nearly three-quarters indicated that FDA guidance documents have improved their understanding of FDA expectations and improved the quality of submissions.

Similar majorities agreed that the FDA promptly facilitated requests for clarification from product reviewers.

The industry’s consensus is that the FDA’s Fast-Track program is working. More than two-thirds of biologic and drug companies indicated that the Orphan Drug or Fast-Track designation facilitated better communications with the FDA and review processes.

Eight in 10 life science companies agreed the FDA has made significant improvements since the FDAMA was enacted, and seven in 10 indicated that their own working relationship with FDA has improved in that time.

An overwhelming majority of biologic (86 percent) and drug company respondents (87 percent) agreed that pharmacovigilance, or post-market surveillance of products, is a key issue facing the industry.

More than three-quarters of biologic companies (78 percent) -- but only a little more than half of drug companies (58 percent) -- indicated that both FDA and industry are doing what they can to address pharmacovigilance and acknowledge it is a complex issue. However, a significant percentage did not agree, indicating there is room for improvement.

While companies expressed a desire to become leaders in pharmacovigilance, they indicated a need for FDA guidance on best practices.

For more than a decade, PricewaterhouseCoopers Pharmaceutical and Life Sciences Industry Group has periodically surveyed the life science industry on its relationship with the FDA, including surveys conducted in 1995, 1997 and 1999.

In 2006, PricewaterhouseCoopers, in partnership with Biocom, surveyed 66 leading drug, biologic product and medical device companies from across the nation as part of the fourth survey in this series.

The complete report is available at www.pwc.com/pharma.

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