President Bush Signs Into Law Legislation To Reauthorize Prescription Drug User Fee Act

Pharma will be paying the FDA a little more to hopefully increase safety...BD

President Bush on Tuesday signed into law a bill (HR 3580) that will expand FDA oversight of prescription drug safety and reauthorize the Prescription Drug User Fee Act, the AP/Long Island Newsday reports (Bridges, AP/Long Island Newsday, 9/27). Under the legislation, the user fees that pharmaceutical companies pay FDA to reduce approval times for new medications will increase by about 25% to $400 million annually. The user fees that medical device companies pay also will increase. In addition, the bill includes provisions that address prescription drug safety, postmarket studies on new medications, prescription drug advertisements, clinical trial disclosures, pediatric trials and conflicts of interest on FDA advisory committees (Kaiser Daily Health Policy Report, 9/21).

President Bush Signs Into Law Legislation To Reauthorize Prescription Drug User Fee Act, Improve Drug Safety