Pharmaceutical, Biotechnology Industry Lobbyists Seek Increased Funds For FDA

Pharmaceutical and biotechnology industry lobbyists hope to convince lawmakers to provide more funds to FDA to help reduce review times for new medications and ensure their safety, the Boston Globe reports. Part of the "motivation" for the effort involves a bill that Sens. Edward Kennedy (D-Mass.) and Michael Enzi (R-Wyo.) plan to introduce this summer, the Globe reports. Among other provisions, the legislation likely would require pharmaceutical and biotech companies to pay higher user fees to cover the cost of increased oversight of prescription drug safety. According to the Globe, "persuading Congress" to increase funds for FDA "could be a hard sell, and, as more and more drugs come into the testing pipeline, debate is intensifying over who will foot the bill. Pharmaceutical and biotech companies maintain that they currently pay significant user fees to reduce review times for new medication and should not have to pay additional fees. Former Rep. James Greenwood (R-Pa.), president of the Biotechnology Industry Organization, said that, although user fees have doubled from 1998 to 2005, the FDA budget has remained about the same from 1986 to 2006. In fiscal year 2004, pharmaceutical and biotech companies paid $232 million in user fees, which accounted for 53% of the $436 million FDA budget for reviews of new medication, and companies will pay $320.6 million in user fees in FY 2007. Greenwood said, "Very simply, FDA is drowning under the weight of its added responsibilities and its budget woes, and it sees (user fees) as its life line." William Hubbard, a former associate commissioner of FDA, added, "The industry is really feeling like there is a steady progression toward them paying" the full cost of FDA reviews of new medications (Henderson, Boston Globe, 7/13).

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