Medical Regulation

The United States regulates, the European Union benefits

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Science  18 Oct 2019:
Vol. 366, Issue 6463, pp. 321
DOI: 10.1126/science.366.6463.321-a

Mandated efficacy testing of coronary stents performed in the United States increased their usage in the EU, where such tests are not required.


Premarket testing of medical products can be costly but can also reduce uncertainty and improve public welfare. Grennan and Town studied prices and quantities for coronary stents implanted from 2004 to 2013 in many hospitals in the European Union (EU) (where only safety testing was required) and the United States (where both safety and efficacy testing were required). As products were undergoing U.S. clinical trials, volatility in their usage decreased and average usage increased in the EU. Neither usage pattern was seen in the EU for products not in U.S. trials, suggesting learning from U.S. trials. Although EU consumers gain some benefit from increased variety in products, there could be substantial gain from more premarket testing.

Am. Econ. Rev. (2019).

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