The FDA is approving more drugs that haven’t been shown to work. Are patients being harmed?
LOS ANGELES — Federal regulators are increasingly approving medicines before studies have shown they work, leaving patients at risk of taking prescriptions that could harm but not help them.
Last year, 14 new drugs received so-called accelerated approval, in which they have not gone through the testing that the Food and Drug Administration regularly requires. That amounted to 28% of the 50 drugs the FDA approved. The numbers have jumped from 2018 when just four, or 7%, of the 59 new drugs were approved under those rules.
The rules were created to be used in rare cases in which seriously ill patients had no other treatments. But with pressure from the pharmaceutical industry, patient groups and politicians to speed medicines to market, now most drugs are approved under the accelerated approval rules or through three similar programs requiring less evidence and regulatory scrutiny.
The shift has alarmed some experts who worry the industry is exploiting the
