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Making Drugs Safe and Available without the FDA
Get Adobe ReaderBy Noel D. Campbell
Executive Summary
There is widespread agreement that the United States Food and Drug Administration
(FDA) needs reforming. The drug approval process in the United States is
too slow, too expensive and too restrictive. The FDA delays the introduction
of new drugs for up to 12 years and does not publish standards of safety
or effectiveness that any drug can meet to ensure its approval. As a result:
Contrary to its recent claims of improved efficiency, the FDA still delays
drug development and approval, while rejecting more applications for approval
of new drugs.
Congress is considering substantial reforms that include elements of the
European drug and medical device approval system: self-certification by
manufacturers, certification by public or private third parties and independent
review committees. However, these reforms would leave FDA bureaucrats in
control of drug approvals or increase political influence over the process.
The best way to make the process more efficient while preserving the safety
and effectiveness of drugs is to adopt a market-based system. In such a
system, the FDA would have little or no role, and private, independent third
parties would certify all drugs and devices.
The model for a market-based drug certification system is Underwriters Laboratories,
Inc. (UL), an independent, not-for-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. It shows how the marketplace can preserve
third-party independence, since UL, consumers and manufacturers all have
incentives to support high standards as well as fast, efficient certifications.
Manufacturers are not legally required to seek UL approval, but tens of
thousands do. Product makers want to meet recognized standards in order
to satisfy consumers and because they are legally liable for unsafe products.
Competition between UL and other organizations ensures the integrity of
the certification process. Even government agencies use UL standards:
Private certification would allow people in different circumstances to balance
the risks they choose to accept. Under such a system, a drug might be available
without third-party certification, but doctors would be very reluctant to
prescribe it. The only consumers who would use such drugs might be those
willing to take great risks, such as terminally ill AIDS and cancer patients,
but no one would be denied access to lifesaving drugs.
Private certification would be faster, less expensive and just as safe as
the current FDA system.