Pharma and FDA: BIOCOM Survey Finds Communication, Agency Turnover are Key Problems

News that industry and FDA relations are improving may elicit knowing looks from some quarters, particularly those politicians who say that the Agency's in industry's pocket. But sour relations between FDA and the drug companies it oversees have contributed to the risk aversion and innovation gridlock that still prevents some drug companies from embracing new technologies and new ways of doing things (particularly QA and QC).The relatively slow rate of adoption of process analytical technologies PAT could be one indicator of the gap separating FDA and industry. But there are others: consider the "dispute resolution" process that FDA put in place several years ago. Anyone who disagrees with the results of a plant inspection can now put it in writing and have it reviewed. How many drug companies have even bothered to file anything? TWO (when I last checked). Updating this picture is BIOCOM and PricewaterhouseCoopers' survey on Industry/FDA relations, "Improving America's Health IV," which was released on Friday (a copy of which I just received). PricewaterhouseCoopers has been tracking the industry/Agency relationship for years---15 years ago, it was very strained, expectations were unclear and communications, poor. This resulted in a lot of very unscientific plant inspections and product reviews and a great deal of variability. A total of 66 biopharma, pharma and medical devices companies responded to this latest survey, which was in progress at BIO 2006 (an indication of how difficult it can be to get the busy folks in the industry to take surveys of any length). Results show significant progress, but suggests a serious need for improvement in a few areas:

• More proactive communication from manufacturers when questions come up (examples could be questions about validation, new drug applications or the use of different approaches or technologies). FDA has become more open to questions and open communications but, apparently, some companies still aren't buying it, or approaching them early in the process with questions
• Agency staff turnover and lack of continuity in the reviewer or inspector assigned to a drug application or facility inspection.

Bullet point number two is particularly telling, since FDA activities have been underfunded for a number of years; travel and training budgets have been cut drastically, and presumably, morale has been an issue. This is one of the key issues that FDA's CMO Janet Woodcock and top Agency officials are addressing, as well as the need for more open discussion and debate (for more, from a March interview, click here). You'll find an executive summary of the BIOCOM/PwC survey results here. But, in the meantime, here are some quick sound bites:

• 75% of respondents agree that FDA has made significant improvements since the FDA Modernization Act of 1997
• When asked about the overall impact of FDA guidance on drug development, 73% say they have a better understanding of FDA expectations, suggesting that, as a result, the quality of their new drug submissions has improved
• 60% described their Agency contact as extremely knowledgeable and responsive. However 43% found it necessary to "escalate the request above the original level of discussion"
• 31% of drug manufacturers and 46% of biologics manufacturers say that FDA changed its position during the review of a new product
• 43% say that FDA personnel changes resulted in a break of continuity in at least one of their reviews
• 68% say that FDA's Critical Path Initiative is on the right track, but only 41% say it is focusing on the right issues
• Over 80% of respondents agree that pharmacovigilance is a key issue facing the industry, with most agreeing that a universal adverse event database would improve patient safety as well as the analysis of safety data.

We'll be interviewing analysts and discussing results of this survey in our next issue and online. Stay tuned.