Wednesday, June 20, 2007

FDA - survey says still a way to go

The public's trust in the US Food and Drug Administration appears to be rebounding after two years of declining confidence, but the agency has more work to do, according to a new survey.

The online poll, which surveyed nearly 2,500 US adults and was conducted by Harris Interactive for The Wall Street Journal, revealed that half of the respondents still believe the FDA is doing only a fair or poor job when it comes to ensuring the safety and efficacy of new prescription drugs.

Six out of 10 give the agency negative ratings on ensuring that truly innovative treatments come to market more quickly.

There are moves afoot to give the agency new powers, notably through the provisions that were recently passed by the US Senate as part of the Food and Drug Administration Revitalization Act, which gives it the ability to issue fines to drugmakers if they fail to do follow-up safety studies or use false or misleading advertising.

The Senate also passed legislation that would establish electronic networks to scan medical and prescription drug records for indications of drug safety issues. However, the Harris survey says that "the public's perceptions of these initiatives, on the whole, are ambivalent at best," but half of the adults polled are confident that that these oversight mechanisms would help improve drug safety.

However it notes that the public is more dubious about legislation passed in the US House of Representatives that would provide funding to the Agency for Healthcare Research and Quality (AHRQ) to compare prescription drugs in order to determine which are most cost effective.

Only one in five is confident that such comparisons would help contain healthcare costs, while only one in three adults is confident that cost-effectiveness comparisons would help ensure that patients receive safe and effective treatments.

Also, public opinion is split as to whether or not allowing the FDA to issue fines would limit people's access to new and innovative treatments. The survey concludes by saying that the public is sceptical about the FDA's reliance on user fees from drugmakers to fund these new oversight activities.

Six in ten adults agree with the view that this could lead to less rigorous scrutiny when reviewing new prescription drugs, while less than one in three believe that having the industry fund these activities is a good way to save taxpayers money.

Source: PharmaTimes

No comments: