Speedy drug approvals lacking in follow-up

Makers of drugs that were quickly approved by the Food and Drug Administration took longer to conduct follow-up studies to confirm that the drugs were safe and effective than pharmaceuticals approved through the normal process, according to a new study.

The study looked at mandated trials of drugs after they were cleared through accelerated approval from 2009 to 2013. The FDA gave accelerated approval to 22 drugs for 24 sicknesses — 19 of which were for cancer — according to the study published in the Journal of the American Medical Association on Wednesday.

Under the accelerated approval process, manufacturers are supposed to conduct studies afterward to confirm the effectiveness of the drugs, and they must be completed within three years.

Manufacturers did 38 trials for the 22 drugs. Of those 38 trials, only 19 were completed within three years.

Of the trials that were completed, most showed some benefit, but the design of the trial wasn’t as robust as standard clinical trials.

The study comes as Congress looks to the FDA to help lower drug prices. Last year, the 21st Century Cures Act was signed into law to help speed up approval of new drugs and revamp how clinical trials are performed to make them easier to complete.

This month, President Trump signed into law an FDA funding package that includes new measures to boost approval of generic drugs to compete with a single-source drug that has a high price.

This post originally appeared on Washington Examiner


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