DALLAS, TX – The Food and Drug Administration's drug and device process is slow, expensive and hazardous to our health, says a new study published by the National Center for Policy Analysis. Despite recent FDA claims of improved efficiency, thousands of patients die because lifesaving drugs and medical devices available elsewhere are not yet approved for use in the United States.
Congress is considering reforms that would leave FDA bureaucrats in control of drug approvals. But the best way to make the process more efficient, the study argues, is to allow private, independent third parties to certify drugs and devices.
"Private certification would be faster, less expensive and just as safe as the current FDA system," said Noel Campbell, author of the study. "And we don't have to start from ground zero; there's an excellent model to copy."
That model is Underwriters Laboratories, Inc. (UL), an independent, non-profit safety certification and standards-writing organization. For more than 100 years, UL has certified the safety of products on which millions of Americans rely. Even government agencies use the UL standards:
- UL certifies more than 14,000 different products including electrical and medical equipment, fire-resistant materials, alarm systems and chemicals.
- Every year, UL issues over six billion UL marks, the "trademark" symbol affixed to items which are UL listed.
- More than 40,000 manufacturers, retailers, insurers, code officials, buyers, architects and government agencies pay for UL inspection and certification services.
"The FDA doesn't have written standards manufacturers can follow to get a new drug approved," said Campbell. "A private certifying organization would have to publish standards that drug researchers and makers can rely on, just as businesses and consumers rely on the UL and their testing procedure to make product quality predictable."
The time required for the FDA testing process has increased significantly since 1963:
- The time required for clinical testing has increased by 140 percent, from 2.5 years in 1963-65 to six years in 1991-93. The total time from laboratory production of a drug to FDA approval has increased 156 percent, from 6.3 years in 1963-65 to 16.1 years in 1988-90.
"The FDA is killing people with these delays," said Campbell. Some examples cited in the study:
- More than 1,230 U.S. deaths from overdoses of sedatives might have been prevented during the five years a safer drug was approved in Britain but not by the FDA.
- Beta-blockers effective in preventing heart attacks and coronary deaths might have saved 10,000 to 20,000 lives a year had they been approved sooner.
- An estimated 1,000 lives were lost when FDA red tape prohibited the manufacturer from selling a defibrillator that it had already approved.
"FDA commissioner David Kessler has taken a lot of blame for these delays, some of it justified," said Campbell. "But Kessler didn't start it, and it won't stop when he leaves."