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.
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Should All Student Debt Be Forgiven?student loans My favorite reform would be making the repayment of all student loans proportional to the borrower’s future earnings.
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Should Lenders Mail Unsolicited Checks to Potential Borrowers?credit & debt When it comes to preying on weak credit risks, it looks like Wall Street is at it again.
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Do Adult Children Have an Obligation to Support Needy Parents?savings Even if some siblings can afford to help more than others, no one should shirk the obligation to assist in some way -- financial or otherwise.
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Should Ethics Determine Who You Do Business With?Smart Buying Consumers seeking to do business only with ethical companies should ask these questions.
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Should Colleges Use Collection Agencies for Overdue Student Bills?college Colleges have many potent options for getting students to square their accounts.
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Hold Soda Makers to Account for Health Woes?Business Costs & Regulation A strong case can be made that it’s unethical for companies to target the very customers who shouldn’t be heavy consumers of a given product.
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Ways to Protect Borrowers From Predatory Home Lendingreal estate Land contracts drain low-income communities of resources.
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Should Employers Be Barred From Asking Job Applicants What They Earn?business The effort to ban the “What are you earning?” question is part of a broader movement to make all compensation totally transparent.
