FDA-approved drugs are rarely studied again


Drug Dilemma?

FDA-approved drugs are rarely studied again

By Ilene Schneider

Almost a third of the drugs approved by the Food and Drug Administration (FDA) turn out to exhibit problems after they are approved and on the market.  Between 2001 and 2010, of 222 new drugs, 61 had to have “black box” warnings applied to their descriptions. Three had to be withdrawn.

Many new drugs are approved by the FDA after only one or a few trials using artificial pro forma guideposts instead of clinical results like hospitalization, recovery rates or patient status. Sometimes clinical indicators such as the visual analog scale are not part of the process of bringing a drug to market, according to some watchdog groups.

While the U.S. Congress passed the 21st Century Cures Act in 2016 to allow the FDA to use “surrogate marker studies” in order to speed the approval process, the absence of real clinical trials is controversial.

“These drugs are widely used after approval, even if subsequent clinical studies are not conducted to confirm the expected benefits,” according to Alison Pease, a medical student at the Downstate College of Medicine of the State University of New York, who took part in a study of the actual effectiveness of new drugs.

“These findings have important implications for clinical care. Both doctors and patients have high expectations for the safety and efficacy of a drug approved by the FDA,” the study concluded.

According to the study, at around 5.5 years after new drugs are released to the market, less than 10 percent have been subjected to any published randomized, controlled, double-blind study. Not even a third of the approved applications of new drugs have been shown by clinical trials to be superior to older drugs.

“But what we’re seeing is that very rarely, either by manufacturers, by government funding or by independent investigators are we getting post-market trials that conform the benefits of drugs with more rigorous study,” says Prof. Joseph Ross, M.D., of Yale University. “If we’re going to have an accelerated system like that, and we want drugs quickly, we need the FDA to have very stern post-market requirements that ensure that the benefits of the drugs are determined within the first three years after approval.”

Nicholas Downing, M.D., of Brigham and Women’s Hospital in Boston, adds that “When drugs are used under real-world circumstances, in a wider patient population, problems can happen, and so scientists need to continually test the drugs.”

In a statement the FDA said, “In general the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue…”

David Gortler, M.D., formerly with the FDA, was more reassuring: Most of the quickly-approved drugs are “niche drugs,” he says, and are not widely used. “There is nothing to be alarmed about in this. We may all be human beings, but drugs react differently in all of us, so you are going to have issues. This is to be expected.”


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