Big Pharma Poised to Pay For Faster FDA Ad Approval

Negotiators representing Big Pharma and the U.S. Food and Drug Administration are close to a deal on raising fees paid by industry to speed up reviews of direct-to-consumer advertising. 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 reports that such advertising budgets have boomed in the past ten years, from $12 million to $4.1 billion.