For the ninth straight year, the US Food and Drug Administration (FDA) is raising the fees companies must pay to have their drugs reviewed. As of October 1, new applications will cost over a million dollars. User fees were instituted in 1992 by the Prescription Drug User Fee Act (PDUFA) to provide funding so that the FDA can conduct timely reviews of drugs. The fees have risen from $100,000 in 1993 to $1,542,000 for a new drug application with clinical trial data. Whether PDUFA has been good for the biotech industry is debatable. Reducing the time to approval (50% reduction since the late 1990s) has meant millions of dollars in revenue, as drugs can be brought to market earlier in their patent lives, according to Mary Olson, at Tulane University in New Orleans. “This expected revenue for most drugs greatly exceeds the user fee even with the proposed increases,” she says. However, Kurt Karst, a lawyer at Hyman, Phelps, and McNamara in Washington, DC, with clients in the biotech industry, says the fees are a concern for smaller companies deciding whether to seek approval for a drug. In a letter to the FDA, the Biotechnology Industry Organization of Washington, DC, pointed out that PDUFA fees now pay a greater share of the budget for drug reviews, almost two-thirds in 2008 up from 42.5% in 2006, and called for transparency on how the fees are used.