Friday, September 28, 2007

Prescription Drugs

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

      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).

FDA officials will complete a review of the 156-page law -- which includes about 200 specific provisions, many with timelines -- before they decide on a plan for implementation. Implementation of some of the provisions in the law might require FDA to draft new regulations or guidelines, a process that can take years to complete, according to Randall Lutter, deputy commissioner for policy at the agency.

Comments
Sen. Edward Kennedy (D-Mass.) said of the law, "It strengthens safety rules for the wave of new miracle drugs coming on the market that Americans count on to protect their health."

FDA Commissioner Andrew von Eschenbach said, "It really represents an important addition to the FDA's authority." Janet Woodcock, deputy commissioner and chief medical officer at FDA, said, "We welcome the ability to really engage in how those products perform once they are out on the market."

Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, said, "The increased fees will allow the agency to expand drug safety monitoring, hire additional staff for postmarket surveillance and modernize its information technology systems" (AP/Long Island Newsday, 9/27).