One of President Trump’s campaign promises was to shorten the approval process for new drugs, and that appears to be happening at a record pace.
The Food and Drug Administration said it approved 46 new drugs last year, the most since 1996, and also approved a record number of new generics, over a thousand. To do so, The F.D.A. streamlined its review and approval process, with the goal of getting generic drugs onto the market in eight to ten months, instead of the current average of four years. The idea is to let the influx of new drugs also lower the price for drugs as a whole.
“We're increasing competition. We're increasing the approval of new branded drugs, and bringing new therapies to market. So it's not going to change overnight,” said Department of Health and Human Services Secretary Alex Azar, “We are not driving for any kind of cheap gimmicks or quick solutions. We're doing things the right way.”
However, critics of the changes said the F.D.A. is simply lowering its standards, and putting consumers at risk for side effects.
“By allowing drugs to come to market ever faster we are exposing patients across the country to increased risks because we didn't learn about the harms that we could have learned had we done better and longer clinical trials before their approval," said Dr. Michael Carome, a drug and healthcare expert.
The F.D.A. said many of the newly approved drugs are designed to treat rare diseases, for which sufferers don’t have a lot of other options. Those people may be far more willing to risk side-effects.