New medications that get the green light from the US Food and Drug Administration for safety and efficacy have more than a one in four likelihood of getting a black box warning or being withdrawn from the market within 25 years of their approval. That compares to one in five drugs getting that distinction in 1992, the year Congress passed the Prescription Drug User Fee Act, which allowed the FDA to collect industry fees to speed drug approvals.
Those findings were based on a study published Monday in the journal Health Affairs in which researchers from the Cambridge Health Alliance, Boston Medical Center, and elsewhere reviewed the most recent data from the Tufts Center for Drug Development to determine how many of the 748 medications approved from 1975 to 2009 wound up being withdrawn from the market or with a black box on their label, the FDA’s harshest way to warn doctors and patients about potentially dangerous side effects — like suicidal ideation caused by some antidepressants.
(The researchers used data from 2010 to evaluate black box warnings, the most recent data available when they began their study.)
But the study couldn’t prove that the expedited drug approval process has led to more dangerous drugs on the market. It’s possible, for example, that the FDA has put more demands on drug companies to evaluate the safety of their drugs after they go on the market.
“We have no good evidence that this is actually happening,” said study leader Dr. Cassie Frank, a primary care physician at Cambridge Health Alliance. Post-marketing studies that the FDA frequently requests from manufacturers of new drugs with uncertain safety risks are “not being completed,” she added.
Her approach for prescribing medications to patients? She waits for any new drug to be on the market for at least seven years before prescribing it to patients — unless it’s a novel, breakthrough drug.
Study co-author and consumer activist Dr. Sidney Wolfe pointed out that the FDA had a system in place for fast-tracking breakthrough drugs before the 1992 law. AZT was the first drug approved to treat AIDS in 1987, after just a few months of review from the FDA. On the other hand, most of the 32 drugs removed from the market for safety reasons, the study found, were “me-too” drugs that were similar to other drugs on the market at the time that they were initially approved.