FDA Doesn?t Test All Drugs, Devices the Same


January 22, 2014

Patients might assume that all approved drugs are created equal.

Yet, new research finds that there can be big differences in the amount of testing that drugs and medical devices go through before being approved or given to patients, according to a series of articles in the Journal of the American Medical Association.

Many heart devices, for example, have been approved through a Food and Drug Administration (FDA) process that assumes newer models are safe and effective based on the approval of earlier versions, a study shows.

These devices, which include implanted defibrillators that shock a faltering heart back into normal rhythm, go through rigorous review when first approved, says Aaron Kesselheim, author of one of the studies and an assistant professor at Harvard Medicine School. Subsequent changes, however, are often made through a "supplemental" review process that doesn't necessarily require them to be tested in clinical trials in humans, Kesselheim says.

"If you took a device approved 15 years ago and you put it side by side with the one from today, they might look nothing like each other," Kesselheim says.

Another study found that many drugs receive less extensive testing than others. Although the FDA usually requires two trials before approving a drug, a study led by the Yale University School of Medicine found that 37% of approved drugs were backed by a single study. Many studies were quite short, with only 34% of new drug approvals backed by a study that lasted more than six months.

Many approved drugs had less-than-ideal testing, says Joseph Ross, an assistant professor at the Yale School of Medicine.

In 45% of drug approvals, researchers measured a drug's effect on "surrogate endpoints"?such as blood test results or cholesterol scores?instead of its effect on real health conditions, such as heart attacks.

Still, Ross notes that FDA drug trials are generally well done and meet basic standards. Nearly 90% of approved drugs were studied in randomized trials, with patients randomly assigned to receive one intervention or another, a design that's considered the gold standard of medical research.

And Ross says the FDA needs to have some flexibility when approving drugs, so that cancer patients and others with life-threatening illnesses can try promising therapies.

In an accompanying editorial, doctors Steven Goodman and Rita Redberg note that the side effects of new drugs often aren't known until years after approval.

In 2009, the FDA took 181 major safety-related actions on drugs, including 25 "black box" warnings. On average, the time between approval and these safety actions is about 11 years, Goodman and Redberg write.

While the FDA may require drugmakers to conduct follow-up studies?to make sure that drugs are safe when used in the real world?many of these studies are never done. Only 31% of the follow-up studies requested in 2008 had been completed by January 2013, Goodman and Redberg note.

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