FDA’s Expedited Drug Review Lets Sketchy New Drugs Slip into the Market

In the 22 years since the FDA implemented a program for pharmaceutical companies to pay a fee to expedite market approval for their drugs, recalls for drugs have increased significantly.

According to research published in the August issue of Health Affairs (subscription required), newer drugs have a 1 in 3 chance of either being withdrawn for safety reasons, or requiring a black box warning on their packaging. Such a warning denotes serious and/or life-threatening side effects of the medication.

As described on AboutLawsuits.com, the Prescription Drug User Fee Act (PDUFA) was enacted in 1992 after heavy lobbying by the pharmaceutical industry. The fast-track law has reduced the average drug approval time from 34 months to 16 months. But at what cost to patient safety? As AboutLawsuits said, the action “may be resulting in large numbers of patients being exposed to dangerous drugs before side effects are recognized.”

In the study, researchers from Harvard, Boston Medical Center/Boston University School of Medicine, City University of New York School of Public Health and Public Citizen analyzed drug approvals by the FDA over the last 35 years – before and after implementation of the PDUFA.

Between 1975 and 2009, the FDA approved 748 “new molecular entities” (NMEs) that were not
over-the-counter drugs. Researchers found that 114 of them subsequently received black box warnings, and 32 were recalled from the market.

According to Public Citizen’s review of the research, drugs that were released after the PDUFA passed were more likely to be withdrawn or have a black box warning; 26.7% percent of them receiving such a warning compared with 21.2% of the drugs that underwent the longer approval process pre-PDUFA. Half of all black box warnings appeared after a drug had been on the market for 12 years, and safety withdrawals have occurred as late as 30 years after a drug’s initial release.

So it appears that fast-tracking approvals might undermine the ability of overseers to detect serious drug side effects. That leaves patients who get these drugs exposed for months or years to danger before they are properly warned, or the drugs are withdrawn. The researchers also speculated that faster approval times could compromise the quality of clinical trial evidence.

One notable example of this rush to approval that had a bad outcome was Vioxx, Merck’s nonsteroidal anti-inflammatory drug (NSAID) that hit the market in 1999, was aggressively promoted directly to consumers as a pain reliever, gained widespread use and was recalled in 2004. According to AboutLawsuits, Vioxx was linked to between 88,000 and 140,000 cases of serious heart disease before it was recalled.

Public Citizen, a consumer advocacy organization, supports a grace period for new drugs. It issued a news release in conjunction with the new study, quoting its lead author, Dr. Cassie Frank: “The FDA is under constant pressure to rush new drugs through the pipeline to approval. In its hurry the FDA is apparently failing to distinguish useful drugs from toxic ones, and more dangerous drugs are slipping through. By the time many drugs receive serious safety warnings, millions of Americans have already been exposed to their side effects, which can sometimes be fatal. As a doctor, I try to keep my patients safe by avoiding new drugs, when there are similar, older ones available.”

The researchers suggested that patients and doctors wait until a drug has been on the market for a considerable amount of time before making it a go-to treatment. We’d go a step further, and suggest that the regulators reconsider the whole idea of pay-for-faster play. When it comes to drugs, faster is only better when it’s solving a problem, not creating larger ones.

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