Many drugs approved by the Food and Drug Administration are not as safe you might think.
According to researchers, about one third of the drugs that are FDA-approved have safety issues later on. That results in recalls, warnings added to boxes, and notices about health risks.
For consumers, it means checking twice before you swallow once. For lawyers, it means mass torts, products liability and failure-to-warn.
New Drugs at the Counter
In a study led by Dr. Joseph Ross of Yale University School of Medicine, researchers found that among 222 new drugs approved by the FDA from 2001 through 2010, about 32 percent resulted in later safety measures.
“The high frequency of postmarket safety events highlights the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle,” the report said.
Among the safety measures, the FDA withdrew 3 drugs, required 61 box warnings and issued 59 safety communications. The median time from approval to first post-market event was 4.2 years.
The researchers noted that FDA approval trials involve fewer than 1,000 patients with follow-up six months later, which may account for the safety measures coming later as long-term affects become apparent. In any case, they concluded, postmarket safety concerns are common.
Lawyers in Line
On one hand, litigators will be combing the report for drugs that have exhibited post-approval problems. In the study, drugs for psychiatric disorders were most likely to have postmarket safety issues.
On the other hand, general counsel may be wondering how much longer it will take for pharmaceutical companies to get FDA approval in light of the new data. It was a sore spot long before the study.
In President Trump’s first speech to Congress, he called out the FDA for having a “slow and burdensome” approval process.” He promised to “slash the restraints, not just the FDA but across the government.”
According to the FDA, the median review time for drug approvals was 10 months in 2016, compared with 27 months in 1993.