An FDA Rx

Can the FDA be brought to health? This is the question asked in To America’s Health: A Proposal to Reform the Food and Drug Administration, by Henry I. Miller, member of the Marshall Institute’s science advisory board. Nobel Prize-winning economist Milton Friedman describes Dr. Miller’s book as “extremely thoughtful, intelligent, and knowledgeable.” Dr. Miller writes:

Prescription drugs are the most cost-effective means of preventing and treating illness. The market for these drugs in the United States is vast – about $100 billion a year, and growing at the rate of 13 percent annually. But their regulation, which vitally affects the availability of new products in patients in need, is a shambles.

Drug regulation, a monopoly of the federal Food and Drug Administration, has become, literally, overkill, and actually threatens public health. The FDA process is slow, overly bureaucratic, and hugely expensive: bringing a single drug to market requires, on average, 12 to 15 years and upwards of $400 million. It is by far the most lengthy and expensive process anywhere in the world.

An effective plan for reform would maintain existing or equivalent standards, with their assurance to consumers of product purity, potency and quality. It would also retain the legal requirement for pre-market demonstration of new drugs’ safety and effectiveness, as well as the FDA’s final sign-off authority for product marketing, and the agency’s responsibility for overarching safety issues.

The seminal change is that day-to-day oversight of drug testing and review of the initial application for marketing approval would be performed by non-governmental, FDA-certified entities. The FDA thereby becomes primarily a certifier of certifiers, rather than a certifier of products.

Delegating a significant portion of the oversight responsibility to these non-governmental certifiers will simultaneously introduce into regulation of drug development several positive elements: competition among the certifiers for drug companies’ business, creating pressure for greater innovativeness and efficiency in the oversight process, and a more appropriate balance than presently exists between regulators’ incentives and disincentives, risks and rewards.

This potent combination of competition and incentives 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 public will benefit directly by earlier access to greater numbers of less costly drugs, and indirectly by greater robustness and productivity in the pharmaceutical industry.

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