Pricewaterhouse Coopers life sciences team ran the 5th survey of pharmaceutical executives -- ceo, coo, a vp or director of regulatory affairs and quality -- representing 50 companies on their ratings of how they thought the FDA was doing.
The results are mixed at best. There seemed to be some agreement that the FDA has improved with its feedback on product development and driving that into companies development plans. But, the agency wasn't seen to have improved much on its drug approval process and especially in the working relationship with pharma surrounding this process. Users fees were another area of mediocrity with criticism leveled at the agency for lack of transparency, excessive fees, lack of effectiveness in speeding review time, and only 24 percent the fees work as intended.
Bottom line: better luck next survey.
Posted by Bruce Lehr November 30th 2010.