Big Pharma Poised to Pay For Faster FDA Ad Approval [1]
Submitted by Jonathan Rosenblum [2] on
Negotiators representing Big Pharma and the U.S. Food and Drug Administration [3] are close to a deal on raising fees paid by industry to speed up reviews of direct-to-consumer advertising [4]. A spokesperson for the trade group BioCentury said that the FDA is seeking to raise about $6.2 million per year, putting individual application review fees at about $41,000. "Industry consultants...welcome this new arrangement," one former FDA official now working for industry told Marketplace. Under the agreement, the FDA will set up a pilot project to assess the benefits and risks of direct advertising--or at least how consumers interpret the risks. University of Minnesota professor Steve Schondelmeyer describes the deal as a "provider-client relationship" in which the federal agency sees itself increasingly as working for industry rather than the public. Meanwhile, a public comment period to the FDA is expected to begin...after the agreement. Although direct advertising of pharmaceuticals in the U.S. dates back to 1983, Advertising Age [5] reports that such advertising budgets have boomed in the past ten years, from $12 million to $4.1 billion.