As I see it: transparency
Apart from a new web page explaining itself in lay terms, at FDA there is no more transparency than there was two years ago—which has provoked New York Democrat Maurice Hinchey, a vociferous FDA critic in the Bush years, to introduce the FDA Improvement Act of 2010.Its aim is to end what Hinchey sees as a financial link and inappropriately close relationship between the drug industry and FDA. It would also improve the agency's post-market drug safety operations, impose fees on drug and medical device company advertising to better monitor ads, and eliminate conflicts of interest on advisory committees.
Most of these objectives could be accomplished in other ways by optimal public transparency, opening the agency to cleansing sunlight from vigilant watchdogs and the media—something that isn't going to happen. Hinchey's bill would do it the old-fashioned way—directing user-fee moneys to be deposited in the US Treasury general fund instead of FDA's account, and providing mandatory congressional funding levels for the agency.Thus, he says, FDA would be fully funded by and accountable to taxpayers. He says the agency currently depends on drug and device company money.
“For far too long,” Hinchey says, “FDA has been structured in a way that benefits the drug companies and undermines the agency's ability to properly regulate these products.”Widening public discontent with government combined with suspicion about what user fees really buy—or, more importantly, are perceived to buy—could give this bill some impetus.
James G. Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)