Although the FDA's rep has improved, the American public is still split on whether or not the agency is doing its job. That's according to a Harris Interactive and HealthDay News online poll.
According to respondents, the FDA's biggest improvement has been in managing prescription drug recalls and withdrawals: 53 percent of participants are confident the agency is doing a good job--versus the 39 percent approval rating the agency received in 2008. As for one of pharma's biggest gripes--getting new drugs to the market more quickly--54 percent believe the FDA needs to step it up, down from 60 percent last year. Likewise, drugmakers have grown frustrated over FDA delays. But the agency has shown improvement, approving 24 new drugs in 2008--more than the number of approvals in any of the prior three years.
When it comes to ensuring the safety of drugs manufactured outside of the U.S., 35 percent of respondents believe the agency is doing a better job than a year ago--an improvement over the 26 percent positive rating the agency received in 2008. In response to criticism over the FDA lack of oversight of foreign manufacturers, the underfunded and understaffed set out to fill 1,300 new vacancies last year and has opened a number of overseas offices over the past year, including several in China and India.
As for whether the FDA was taking care of its top pharma priority--"ensuring the safety and efficacy of new prescription drugs"--opinions have bounced up and down over the past few years. In 2008, the FDA received its lowest rating in 5 years with the agency only managing to gain a 35 percent approval rating. This year, responses were evenly split 47 percent positive to 47 percent negative. Opinions regarding whether the agency effectively monitored the safety of drugs once they were on the market was also split 47 percent positive to 46 percent negative.
Add the public's lack of confidence to the mounting grumblings about the FDA: Agency insiders have complained that leaders aren't to be trusted, the Government Accountability Office has said the agency is a "high-risk" problem, pharma types believe the FDA is too politicized, and on and on. Kathleen Sebelius has her work cut out for her.
- here's the release
- and the results (.pdf)