Nation's Life Science Firms Report Progress with the FDA, Yet Significant Challenges Still Exist
SAN DIEGO, CA and WASHINGTON, D.C.- May 23, 2007 – The nation’s pharmaceutical, biotechnology and medical device companies report that the U.S. Food and Drug Administration (FDA) has made progress with improved guidance, expectations and approvals, but the industry remains concerned about a number of regulatory challenges. A national report issued today outlines a series of issues that still need to be resolved to improve product review delays and shorten the approval process via user fees.
These findings are part of the fourth survey of the medical device and life science industry, released today by BIOCOM and PricewaterhouseCoopers LLP entitled, “Improving America’s Health IV.” Latham & Watkins, a global law firm, provided underwriting assistance for the report. The report includes detailed recommendations that the industry and the FDA can implement to ensure improvement in a number of areas.
“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, the association for the Southern California life science community. “The good news is that these relationships have greatly improved since enactment of the Food and Drug Administration Modernization Act of 1997 (FDAMA).”
Despite significant progress, the report shows the industry and the FDA need to work together to overcome these challenges. Key findings of the report:
- 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 turn-around times were most frequently cited (by 61% 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 ten companies surveyed (61%) 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 (33%), including half of medical device firms (50%), 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 during 2007.
Life Science Companies Not Taking Advantage of Key Programs
- 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 (62%), 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.
Industry Supports FDA Critical Path Initiative but Questions Its Focus
- The FDA Critical Path Initiative was designed to modernize the scientific process through which products are developed. A majority of life science companies (58%) said they are familiar with the Critical Path Initiative and a majority (64%) agrees with its importance, but only 41 percent agreed it is focused on the right issues.
FDA Has Improved Guidance and Expectations of Life Science Companies
- The FDA is providing better guidance and clearer expectations. Nearly three-quarters (73%) 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 ten life science companies agreed the FDA has made significant improvements since the FDAMA was enacted, and seven in ten (70%) indicated that their own working relationship with FDA has improved in that time.
“The vast majority of companies we surveyed indicated that the available FDA guidance documents are useful and they would like to have guidance in areas for which it currently does not exist,” said Michael Mentesana, director of PricewaterhouseCoopers’ Pharmaceutical and Life Sciences Industry Group. “For example, everyone agrees that post-market scrutiny of products is vital, and the FDA needs to support the industry by providing clear guidance on effective pharmacovigilance solutions, including risk management and improving reporting and submission processes.”
Industry and FDA Must Work Together on Pharmacovigilance
- An overwhelming majority of biologic (86%) and drug company respondents (87%) agreed that pharmacovigilance, or post-market surveillance of products, is a key issue facing the industry. More than three-quarters of biologic companies (78%) – but only a little more than half of drug companies (58%) – 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.
John Manthei, a partner in the Washington, D.C. office of Latham & Watkins LLP and former Majority Counsel to the U.S. House of Representatives Committee on Commerce, stated, “The survey results come at a key time for FDA, industry and Congress as they work to build efficiencies into the drug, biologic and medical device approval process through reforms to PDUFA, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Agency’s Critical Path Initiative. The survey is a significant step forward in helping both sides understand each other’s strengths and weaknesses which will be critical in making these reform efforts successful.”
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, the world’s largest regional life science association, 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.
BIOCOM is the largest regional life science association in the world, representing 550 member companies in Southern California. The association focuses on initiatives that position the region’s life science industry competitively on the world stage, and on the development and delivery of innovative products that improve health and quality of life. This includes initiatives in capital formation, public policy, workforce development, and member services. For more information on BIOCOM or the Southern California life science community, please visit the organization’s Web site at www.biocom.org or call (858) 455-0300.
About PricewaterhouseCoopers LLP
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“PricewaterhouseCoopers” refers to the network of member firms of PricewaterhouseCoopers International Limited, each of which is a separate and independent legal entity.
About Latham & Watkins LLP
Latham & Watkins is a global law firm with more than 1,900 attorneys in 24 offices, including Barcelona, Brussels, Chicago, Frankfurt, Hamburg, Hong Kong, London, Los Angeles, Madrid, Milan, Moscow, Munich, New Jersey, New York, Northern Virginia, Orange County, Paris, San Diego, San Francisco, Shanghai, Silicon Valley, Singapore, Tokyo and Washington, D.C. For more information on Latham & Watkins, please visit the Web site at www.lw.com.