At BIO 2010 in Chicago, PricewaterhouseCoopers revealed some of the initial data of its fifth report (others were 1995, 1997, 1999, and 2006) looking at the relationship between the drug industry and FDA. PWC partnered with Biocom to survey large and small manufacturers of different stripes and sizes. On the whole, there are some positive signals in the numbers—recent guidance documents have served to clarify the Agency’s motives and expectations, for example—but lingering concerns about FDA’s competence and governing influences persist. Among the concerns cited by a panel of experts gathered at BIO was the Agency’s inordinate emphasis on drug safety, at the expense of a focus on efficacy.
The full report will come out in the fall, including insight and comparisons with data from previous surveys. PWC plans to discuss the data in meetings with FDA commissioner Margaret Hamburg and other key personnel.
Some of the initial findings, as reported by PWC’s Michael Mentesana, are as follows:
Influences on Approvals
• 57% of respondents agree or strongly agree that politics has had too much influence on drug, device, and diagnostic approval.
• 67% feel FDA should not have the authority to approve or deny a drug based on its economic or clinical value
FDA and Industry Improvements
• 39% of the respondents feel that the overall working relationship with FDA has improved over the past two years.
• Approximately 80% agree that FDA is providing better guidance documents.
• 67% improved their relationships by incorporating FDA feedback into the development process, which is approximately a 17% increase over the past two years.
Ongoing Struggles During FDA Reviews
• Approximately 40% of respondents feel some products were denied primarily because of FDA’s inadequate review resources.
• 49% of the respondents agree or strongly agree that FDA staff changes resulted in a break in continuity of at least one of their reviews.
• Over 50% of the respondents said FDA changed its position on at least one review. This is up from 40% in 2006.
Pre-submission/End-of-Phase Meetings
• 64% of respondents agreed pre-submission/end-of-phase meetings improved the quality of their application and 58% agreed they expedited their application.
• Only 20% of respondents indicated the meetings reduced the effort required to complete their application.
• The industry did not always take advantage of the meetings, nor did the FDA consistently encourage attendance. “This may be because the guidance documents are clearer.”
Ongoing Initiatives
• More than half of the participants are not familiar with Critical Path and Sentinel System initiatives, and 75% are not familiar with Clinical Trials Transformation Initiative (CTTI).
• 55% of the participants familiar with Critical Path feel that FDA lacks the capability necessary to implement the initiative.
User Fees
• Approximately half of the participants feel that there is a need for greater transparency around the purpose of user fees.
• Only 24% of respondents agree that FDA is utilizing user fees as intended.
• Only one-third of participants feel that user fees accelerated the review process.
By Paul Thomas, Senior Editor
