Caution Kills

The FDA’s regulatory malaise harms innovators, too. Today, device companies are launching products in Europe years before they approach the U.S. market. The New York Times recently highlighted the story of a California woman who had to travel to Europe to have a specific spinal device that was manufactured just 40 miles from her home. She could not get the device in the United States because the FDA was still reviewing the product.

A recent scorecard by PricewaterhouseCoopers revealed that the United States ranks seventh out of nine nations in medical-device approval times. Other analyses found that FDA reviews for most medical devices take two years longer than reviews for similar products in Europe, with little or no discernible benefit in patient safety or outcome.

From a Washington Times editorial by Sens. Richard M. Burr and Tom Coburn (emphasis added).

Comments (6)

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  1. Virginia says:

    It’s so easy to Google stories about people who died from Vioxx or whatever other medicine, but you never hear about all those people who died while waiting for other drugs to be approved.

    I bet if the FDA put a counter on its website that showed all the people dying of a particular disease during the drug approval process, you’d see a lot faster approvals.

  2. Linda Gorman says:

    An estimated 100,000 people died waiting for beta blockers to be approved in the US. That’s one drug. There are lots of other cases. Gieringer (1985) estimated that the range of deaths due to regulatory delay are 21,000 to 51,000 lives per decade on the low end and 51,000 to 120,000 lives per decade on thei high end.

    Many fewer lives were lost to drug catastrophies in countries with less regulation. Most of the worst cases occurred in the 1960s and may have been larger than necessary due to poor followup. Gieringer estimates that FDA regulation prevented 5-10,000 casualties a decade compared to regulation in other countries.

    If accurate, these numbers suggest that the FDA is not a good deal for U.S. citizens.

  3. Ken says:

    Virginia, there have been estimates. It totals tens of thousands of people.

  4. Devon Herrick says:

    The FDA’s calculus of risk versus benefit is heavily weighted towards minimizing risk rather than maximizing benefit. It’s easy to count the people who are harmed by an approved drug (or in the case of Vioxx claim they were harmed despite a lack of evidence of harm). On the other hand, it’s not as easy to quantify the people who would have benefited. Thus, I suspect the ratio of people who harmed because a drug or device was not approved quickly enough to those harmed by a drug approved too quickly is probably 10 to 1.

  5. Bruce says:

    It’s not caution that kills. It’s CYA that kills.

  6. Tom H. says:

    Linda, thanks for the numbers.