FDA, Pharmaceutical Industry Officials Testify on Prescription Drug Safety System
A "lot of improvement" is possible in the U.S. drug safety system, but FDA should not be held solely accountable for the system, acting FDA Deputy Commissioner Janet Woodcock told an Institute of Medicine committee on Wednesday, USA Today reports (Rubin, USA Today, 6/9).
Woodcock said the nation's drug safety system has "pretty much broken down." According to the New York Times, Woodcock "emphasized ... the agency could do only so much to curb problems with drugs already on the market" and said the IOM committee also should consider the roles physicians, pharmacists and hospitals have in monitoring drugs already on the market.
In addition, Woodcock said FDA should use information from managed care organizations' electronic health record systems to help address the issue. According to Woodcock, FDA hopes to change the drug development system to identify rare adverse events before drugs reach a wide market.
She said, "The bottom line is that a lot of drug safety problems are actually preventable [because] most adverse events are from known side effects." Woodcock said, "The keystone of the current system is the prescriber, and that person is the one who decides if the benefits of a drug outweigh the risks for that patient." She continued, "This system has obviously broken down to some extent, as far as the fully informed provider and the fully informed patient" (Harris, New York Times, 6/9).
In November 2004, acting FDA Commissioner Lester Crawford requested the IOM committee as one of several steps aimed at improving the safety of drugs on the market. The committee will continue to meet over the next year and issue a report in July 2006, according to committee co-chair David Blumenthal (USA Today, 6/9).
In addition to Woodcock, the panel heard comments from drug industry officials, consumer advocates, pharmacists and other representatives from the health care industry, USA Today reports.
Bill Vaughan, a senior policy analyst at Consumers Union, said the time frame of the committee's evaluation could delay changes in the system. Vaughan said, "There seems to be no recognition of or urgency about the well-established need for significant and immediate policy reforms," adding, "Because safety has taken short shrift at the FDA, people have died, unnecessarily and prematurely" (Nesmith, Atlanta Journal-Constitution, 6/9). In addition, Vaughan called for an independent federal center for drug safety.
Alan Goldhammer, associate vice president of the Pharmaceutical Research and Manufacturers of America, opposed a drug safety center, saying the "current legal authorities over drug safety are robust and need not be altered" (New York Times, 6/9). Goldhammer also said PhRMA was disappointed that its request for a seat on the committee was not granted (Atlanta Journal-Constitution, 6/9). He added, "PhRMA finds it curious that industry is not mentioned as one of the actors."
John Gans, CEO of the American Pharmacists Association, said pharmacists should have a larger role in ensuring the correct prescribing and use of drug. He said, "The safest drug in the world is not a safe drug if it's not used correctly" (USA Today, 6/9).