Bush Approves Five-Year Reauthorization Measure for Prescription Drug User Fee Act
President Bush on Wednesday signed into law a measure that reauthorizes for five years the Prescription Drug User Fee Act, Reuters reports (Richwine, Reuters, 6/12). Under PDUFA, last renewed in 1997, the FDA charges drug companies a fee in exchange for an expedited review process. The law allowed the FDA to reduce the average review time for new drugs to less than one year in 1999, from about two years in 1990. The fees account for about 12% of the agency's budget (California Healthline, 3/14). Under the reauthorization, contained in the $4.6 billion bioterrorism preparedness bill, the FDA expects to collect an estimated $1.2 billion over the next five years. Those fees will help the agency hire additional safety inspectors to monitor the safety of drugs after they reach the market. The pharmaceutical industry supports PDUFA, but some consumer advocacy groups have said that the program "presents a conflict of interest for the FDA by forcing it to rely on money from the firms it regulates" (Reuters, 6/12).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.