US FDA-pharma agreement on advert user fees

The US Food and Drug Administration has reported an agreement on user fees for the agency's evaluation of television advertisements with the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization. The FDA would receive $40,000-$50,000 per year for each advertising campaign individual firms were planning. If the agency fails to raise $6.0 million from the user fee scheme, the rates would increase and, in the first year, drugmakers will pay double in order to provide a contingency reserve, according to the Wall Street Journal.

The proposals require ratification from the Department of Health and Human Services and the US Congress. The WSJ described the reported deal as "a first step in what will be a far broader debate over whether, and how, to reform [the] FDA," in the light of the recent election victory by the Democratic party (Marketletters passim).