Tag: FDA

Using Marketable Vouchers to Speed Up Drug Approvals »

The Food and Drug Administration recently approved a new drug for leishmaniasis, an extremely rare disease which is spread by sand flies in poor countries. Why would a for-profit company invest in inventing a drug for which there is no way to make a profit? The FDA offers a prize to any firm that...
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The FDA’s Productivity and Consistency Have Collapsed in a Decade »

Joseph A. DiMasi, Christopher-Paul Milne, and Alex Tabarrok have written a devastating Report Card demonstrating how poorly the Food and Drug Administration (FDA) does its business. The FDA has a government-granted monopoly on deciding the safety and efficacy of new medicines. Nobody in America is allowed to choose to take a medicine not approved...
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FDA Continues to Impede Medical Device Innovation »

In the Wall Street Journal this week, Dr. Scott Gottlieb discussed (gated, by subscription only) a worrying trend in the Food and Drug Administration’s regulation of medical devices. Increasingly, the FDA is demanding that device makers conduct trials of new devices by randomly assigning patients to the new device . . . or to...
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FDA Regulations Kill »

Paul Howard and Yevgeniy Feyman in Health Affairs: Meningitis is a terrible disease that can kill its victims in a single day. About 4,100 new cases are diagnosed annually in the U.S., with a mortality rate of more than 10 percent. Even with treatment, survivors are often left with serious side effects that can...
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Federal Government Gives Patients a New “Right”: Access to Lab Results »

Many patients groups and their allies understandably cheered a new regulation that just came about as a result of many years of advocacy: Nationwide, patients now have a “right” to access their lab results directly. The “right” to receive test results directly from labs now ranks equally with the “right” to get our medical...
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