FDA Too Slow To Approve New Medical Drugs And Devices
Washington, DC, April 30, 2002—A new nationwide poll of cancer specialists sponsored by the Competitive Enterprise Institute finds many of them believe the FDA is too slow in approving new medical drugs and devices. <?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />
CEI’s poll is being released as the agency’s drug approval process once again becomes the subject of much debate, with some arguing that drugs are being approved too quickly, while others believe skyrocketing costs and regulatory barriers are affecting drug development. The recent controversy over the FDA’s rule for testing pediatric drugs may add another regulatory hurdle to the process.
Highlights of the poll include:
· Almost two-thirds (61%) of the cancer specialists polled believe the FDA is too slow in approving new medical drugs and devices.
· When doctors were asked if FDA regulations helped or prevented them from using promising new drugs or medical devices in the treatment of their patients, there was an almost even split.
(43% Help, 44% Prevent)
· Almost eight out of ten (77%) responded that the FDA’s approval process has hurt their ability to treat their patients with the best possible care at least once in their medical careers.
· Almost two-thirds (70%) believe the general public doesn’t understand the “human cost” of the FDA approval process—that some people may suffer or die waiting for the agency to act.
· More than half (58%) say the FDA should not restrict information on the use of approved drugs or devices for other unapproved uses, also known as “off-label” uses.
U.S. Senator Bill Frist (R-TN), co-sponsor of legislation in 1997 to reform the FDA, made this statement regarding CEI’s poll: “What used to take several years has now been reduced to an average review time of six to 10 months for new drugs. Yet, as many respondents indicated, more needs to be done to further improve the drug review process.”
The entire poll can be read online. The survey—the fifth on this topic sponsored by CEI since1995—was conducted by the polling company. It included 160 cancer specialists, with a margin of error of +5.1% at the 95% confidence level.
CEI is a non-profit, non-partisan public policy group dedicated to the principles of free enterprise and limited government. For more information about CEI, please visit our website at www.cei.org.