In late 2015, Senator Ted Cruz introduced a bill to make more drugs available to Americans more quickly. Specifically, his idea would have the Food and Drug Administration approve products for which there is an unmet medical need if those drugs or devices were already approved by regulators in other “trusted” countries. To further cut red tape, the FDA would have just 30 days to make a decision.
So far, his bill has gone nowhere. Meanwhile, a new analysis finds the effort may have a limited impact.
After reviewing 282 drugs that were approved by the FDA between 2001 and 2010, researchers found that 110 had been previously approved by European and Canadian regulators. Of those, 37 drugs — or 34 percent — had a novel mechanism of action, which means they worked in new ways. But only 10 of the 37 drugs lacked alternatives in the US, and of those, nine were approved to treat rare diseases, according to the analysis published in BMJ Open.
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Other trusted countries would includes those in Europe that approved thalidomide, for instance? And the result was many deformed babies. While in the U.S. our FDA did not approve it, and the application was only withdrawn after the results in Europe piled up. And how many drugs that were approved in the U.S. have been withdrawn due to adverse consequences…..more than a few. They need to be careful tinkering with the approval process, or else the rest of us will have to pass up all new drugs from now on, out of caution, since the regulators are not going to be as careful, thanks to congresspeople who think they are helping. The drug companies is who they will be helping, not the damaged patients.