SAN DIEGO, May 23, 2007 (PRIME NEWSWIRE) -- 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 sciences industry, released today by PricewaterhouseCoopers LLP and BIOCOM 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 sciences 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 sciences 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 sciences 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 sciences 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.
Other findings:
Life Sciences Companies Not Taking Advantage of Key Programs
* Life sciences companies appear to not be taking full advantage of
better communication and guidance from the FDA. One-half of life
sciences 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 sciences 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 Sciences 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 sciences 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 sciences 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 sciences 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.
About PricewaterhouseCoopers LLP
PricewaterhouseCoopers (www.pwc.com/lifesciences) provides industry-focused assurance, tax and advisory services to build public trust and enhance value for its clients and their stakeholders. More than 140,000 people in 149 countries across our network share their thinking, experiences and solutions to develop fresh perspectives and practical advice.
"PricewaterhouseCoopers" refers to the network of member firms of PricewaterhouseCoopers International Limited, each of which is a separate and independent legal entity.
About BIOCOM
BIOCOM is the largest regional life sciences association in the world, representing 550 member companies in Southern California. The association focuses on initiatives that position the region's life sciences 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 sciences community, please visit the organization's Web site at www.biocom.org or call (858) 455-0300.
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.