How Can the Approval Process for New Drugs Be Speeded Up?

Question: I keep hearing that many promising new drugs for cancer and other diseases are not legally available in this country because of excessively long and expensive approval processes at the U.S. Food and Drug Administration. What can be done to speed things up without sacrificing patient safety?

Answer: The FDA, which is the sole arbiter of the safety and efficacy of drugs and medical devices sold in America, has greatly improved the speed of its review of proposed new drugs in recent years. The average length of time for approval has been declining, and the percentage of applicants getting okayed has generally been rising.

But thoughtful critics argue that the pace of innovation in pharmaceuticals and medical devices will soon overwhelm the present system of exclusive federal oversight. The fast-evolving field of customized medicine might render obsolete a system based on proving efficacy for the general population. There are many reform proposals, including some from free-market think tanks. A few worth considering:

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• Reciprocity between the drug-approving authorities in the U.S. and other authorities with similarly high standards, such as those in the European Union, Canada, Japan and Australia. A drug approved by one nation would be legal in the others, spreading out the regulatory workload and saving drug companies the cost of duplicative applications.

• Free-to-Choose Medicine, in which doctors and patients could select a drug that hasn’t been fully approved by the FDA—but has been given provisional approval based on preliminary findings of its safety and efficacy—to use while research continues. This would expand the FDA’s current use of conditional approval, which is restricted to drugs for life-threatening diseases. Patients would need to understand the risks, and drugmakers would want them to sign a waiver of liability.

• Congressional authorization of new, nonprofit certification bodies that would exist in parallel to, and in competition with, the FDA. Such a system is used today in the European Union for medical devices but not yet for pharmaceuticals.