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Making Drugs Safe and Available without the FDA
The Need for More Fundamental Reform
"The drug approval process could be made faster and more cost effective without sacrificing the safety and effectiveness of drugs."
In order to determine if proposed FDA reforms will accomplish their purpose,
we must consider the general nature of regulatory reform as well as specific
proposals. Generally, what Congress deregulates it can reregulate. And it
has a history of forcing the political pressure it feels onto the backs
of the agencies under it. Consequently, federal agencies are marked by "mission
creep." What begins as a simple and understandable mandate for safety
and effectiveness becomes a welter of confusing and contradictory congressional
demands. Joel Nobel, president of ECRI, an independent medical-device testing
company, explains Congress' approach to the FDA:
First require that the FDA do the unwise or impossible. A few
years later, ask the General Accounting Office to tell you if the FDA is
doing the unwise or impossible as instructed. Express shock and surprise
when you learn that it is not. Hold hearings to pistol-whip the FDA and
industry in order to support the passage of more unwise or impossible-to-implement
legislation.38
The drug approval process could be made faster and more cost-effective without
sacrificing the safety and effectiveness of drugs. How? By moving to a market-based
system in which no one could block drugs from entering the market, and no
one could prevent consumers from making their own decisions about the drugs
they used. The FDA would have no substantial role, as private third parties
would certify drugs and devices. This system is not only possible, but preferable.39
Privatizing government functions is now commonplace. Yet questions and fears
remain. We can address them because in this instance we know what is likely
to happen when the FDA no longer compels premarket approval. Our guide is
an institution that has certified safety for more than 100 years: Underwriters
Laboratories, Inc., an independent, not-for-profit safety certifications
and standards-writing organization.