'Reciprocal approval' would benefit rare disease patients while putting other populations at risk, study finds

"Reciprocal approval" would allow the Food and Drug Administration to automatically sign off on new drugs already approved in other countries. While some healthcare players believe this strategy could help lower drug prices and give patients access to treatments sooner, the tactic would pose a threat to much of the population, according to a new study in BMJ Open.

Here are five things to know.

1. For the study, researchers examined new drugs approved by the FDA, the European Medicines Agency and Health Canada between 2000 and 2010. Researchers assessed drugs approved by the EMA and/or Health Canada before the FDA for various characteristics, including mechanistic novelty, probable clinical impact, size of affected population and the FDA's review outcome.

2. From 2001 to 2010, 282 drugs were approved in the U.S., Europe and Canada. Of those, 172 (61 percent) were first approved in the U.S., 24 (9 percent) were never approved in the U.S. and 86 (30 percent) were approved in the U.S. after Europe and/or Canada, according to the report.

3. Of the 110 new drugs approved in Europe and/or Canada before the U.S., 37 (34 percent) used novel mechanisms compared to drugs already approved by the FDA. However, only 10 (9 percent) of these drugs were treatments for conditions lacking alternate available therapies in the U.S., and nine out of 10 of the drugs were intended to treat rare diseases.

4. Twelve of the 37 drugs first approved in Europe and/or Canada using novel mechanisms were rejected by the FDA on their initial submission for safety reasons. Two of the drugs were ultimately withdrawn from the European market for safety concerns.

5. Reciprocal approval would likely benefit only a small number of American patients with rare diseases, while exposing the larger U.S. population to potential safety risks, conclude the authors.

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