HHS OIG Says FDA Should Take Longer To Review New Prescription Drugs
The FDA should consider adding 30 to 60 days to the 10 months that it currently takes on average to review applications for new prescription drugs, the HHS Office of Inspector General stated in a report issued last week, Long Island Newsday reports. The report surveyed FDA physicians, pharmacists and officials who review prescription drug applications. According to the report, 25% of respondents said that the FDA should take longer than the average 10 months to review standard applications for new medications, and 58% said that the agency should take longer than the average six months to review expedited applications, such as those for a cancer or HIV treatments. FDA Commissioner Mark McClellan said, "The value of such an extension must always be balanced against the perception that FDA would be 'slowing down' or 'taking more time' for the most important drugs we review" (Long Island Newsday, 4/1). In response to the report, consumer advocacy group Public Citizen said that the FDA does not conduct adequate reviews of new medications. "The FDA is supposed to rigorously screen all new drugs and ensure than they are safe and effective before they are sold to millions of people," Dr. Peter Lurie, deputy director of the Health Research Group at Public Citizen, said, but he added that without reforms to the review process, "unsafe drugs will continue to slip through the safety net" (Public Citizen release, 3/31). The OIG report is available online. Note: You must have Adobe Acrobat Reader to view the report.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.