For Better Access To Prescription Drugs, Reform The FDA
April 26, 2001
Politicians are wooing elderly voters by offering a vast new entitlement program in the form of payment for prescription drugs under Medicare. No matter who pays the subsidy for prescription drugs to Medicare recipients, this new entitlement will merely treat the symptoms, not the underlying cause of costly drugs, says former Food and Drug Administration (FDA) official and physician Henry I. Miller.
Instead, Congress should opt for a lower-profile but more effective remedy for unaffordable drugs: FDA reform.
Prescription drugs are expensive, but highly cost effective, and pharmaceutical advances have made inroads against a variety of acute and chronic illnesses. However, FDA approval of these products is slow and hugely expensive. For example:
- Bringing a single drug to market requires 12-15 years,
- The process costs upwards of $500 million,
- And it is the most lengthy and expensive process of its kind anywhere in the world.
Reforming the FDA by introducing competition and incentives to encourage the agency to become more efficient at getting safe, effective drugs to patients can transform the drug development process and reverse the current upward spiral of increasing time and costs.
The seminal change would be to have day-to-day oversight of drug testing and review of the initial application for marketing approval performed by competing, nongovernmental, FDA-certified entities. The FDA would thereby become primarily a certifier of certifiers, rather than a certifier of products.
Already in the European Union, the majority of medical devices are certified by third-party reviewers. As a result, the approval process in Europe takes perhaps half as long as in the U.S., shortening the overall development process by roughly two years, and without compromising safety.
FDA reform would benefit the public directly by granting earlier access to greater numbers of less costly drugs, and indirectly by providing greater robustness and productivity in the pharmaceutical industry.
Source: Henry I. Miller, "To America's Health: A Proposal to Reform the FDA" (Hoover Institution Press, 2000), and "Americans Are Dying for FDA Reform," Hoover Institution Weekly Essays, April 9, 2001.
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