US FDA and life sciences industry relationship complicated by new science and changing expectations, PwC survey reveals

Growing public demand for increased drug and medical device safety, as well as the need to develop medical products faster, is complicating the current regulatory approval process and relationship between the life sciences industry and its chief regulator, the U. Food and Drug Administration, according to a new PricewaterhouseCoopers (PwC) report, titled Improving America's Health V - A survey of the working relationship between the life sciences industry and FDA.

The study found that life sciences companies feel communication with FDA has improved steadily since passage of the FDA Modernization Act of 1997, but new expectations are fueling frustration with the regulatory review process. It revealed that:

• 38% of life sciences companies in the study said they feel that the overall working relationship with the FDA has improved over the past two years, and 80% said that the agency is providing better guidance about its expectations. 68 of companies said they are incorporating this feedback into product development.
• 64% said that meeting with the FDA before submitting review materials improved the quality of their applications, and 87% thought it expedited their applications, but industry did not always take advantage of the meetings and only about half (53%) said the FDA consistently encouraged these meetings.
• Six in 10 companies expressed frustration that the FDA had changed its position during a review, and four in 10 feel that some products were denied because of the FDA's inadequate review resources.
• The industry feels that the FDA is not keeping up with rapidly advancing technology. Only 8% of of drug and device makers think the FDA is doing enough to advance personalized medicine.
• More than half (56%) of respondents who are familiar with the FDA's Critical Path Initiative to bring innovative, high priority therapies to market quickly think that FDA currently lacks the capability to implement the initiative.