FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, Researchers Find
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The Food and Drug Administration is approving drugs more quickly than ever. Some researchers say this faster action comes with a tradeoff - less reliable evidence. NPR health correspondent Sydney Lupkin reports.
SYDNEY LUPKIN, BYLINE: The FDA is approving more new drugs than ever, and it's doing this faster than in previous decades. This is according to a new study published in JAMA, the Journal of the American Medical Association. About 30 years ago, it took almost three years for the FDA to approve a new drug. And by 2018, it had dropped to a little over 10 months. But there may be a downside. Here's lead study author Jonathan Darrow of Harvard Medical School.
JONATHAN DARROW: There has been a gradual erosion of the evidence that's required for FDA approval.
LUPKIN: The agency has added programs to allow it to approve drugs based on fewer clinical trials. The FDA also relied on more things like lab tests and scans. For cancer, that might mean testing whether a drug shrinks tumors instead of whether it improves survival after treatment. Darrow says that may mean new, expensive drugs aren't necessarily better than the drugs already on the market.
DARROW: Patients who are seeking treatment from their physicians should recognize that there's greater uncertainty with the new drugs. And they may want to ask whether an older drug is available that might do just as well in this particular case.
LUPKIN: Dr. Joshua Sharfstein was FDA principal deputy commissioner during the Obama administration. He says there's a sense in Congress that to get more cures on the market, you need to offer drugmakers incentives.
JOSHUA SHARFSTEIN: In some cases, that may actually help, you know, great products make it through. In other cases, it may be lowering the standards for evidence in a way and making it actually less likely that doctors and patients will know whether products work.
LUPKIN: Sharfstein wrote an accompanying editorial in JAMA about the study.
SHARFSTEIN: We've kind of reached a point where it makes sense to pause and see whether we can do things better. And I think we can.
LUPKIN: He offered several suggestions for change. For example, Congress needs to reevaluate FDA expedited approval programs to see what's working and what's driving up health care costs.
Sydney Lupkin, NPR News.
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