Sam Kazman, CEI, 202.331.2265
Kellyanne Conway, the polling company, 202.667.6557
Dr. Robert Nirschl, orthopedic surgeon, 703-525-2200, x102
Washington, D.C., January 30, 2007—The federal Food and Drug Administration is too slow to approve new drugs and medical devices, according to a survey of orthopedic surgeons released today. A strong majority of the surgeons believe that FDA approval delays hinder hurt patients and hinder their practice of medicine. Eighty percent would also like to see the painkiller Vioxx, which was voluntarily withdrawn in 2004, available once again.
“In recent years FDA has been repeatedly attacked for approving allegedly defective therapies. But as this physician survey shows, the real threat to public health is that FDA’s approval process is already too long. Any attempt to make it more stringent will only worsen this problem,” says Sam Kazman, CEI’s general counsel and head of the institute’s Death by Regulation Project.
Dr. Robert Nirschl, head of the Nirschl Orthopedic Center for Sports Medicine and Joint Reconstruction in Arlington, Virginia, and an associate clinical professor of orthopedic surgery at Georgetown University, says that, “while there are individual exceptions, the FDA process is too cumbersome overall” and the agency is “too defensive and overcautious.”
Among the highlights of the new survey are the following:
- over three-quarters, 76%, believe FDA’s approval process is too slow;
- 60% believe FDA hinders their use of new therapies;
- 73% believe FDA approval delays hurt patients;
- 70% favor changing the law to give physicians access to unapproved therapies if they carry a warning about their unapproved status;
- 80% favor having Vioxx available again.
This is the sixth in a series of medical specialist surveys conducted by CEI, beginning with a 1995 poll of oncologists. These surveys have consistently found a high level of dissatisfaction with FDA’s performance, though the newest poll shows an exceptionally negative view of the agency.