A new study reveals that approximately one-third of new drugs approved by the U.S. Food and Drug Administration (FDA) pose safety risks after they have been put on the market and are available to the public, The Washington Post reports.
Researchers noted that the study, which was published in JAMA (Journal of the American Medical Association), shows the necessity for continued monitoring of new treatments for years after they are released to the market. “We seem to have decided as a society that we want drugs reviewed faster, remarked associate professor of medicine and public health at Yale University and lead author, Joseph Ross. That makes it vitally important “that we have a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively,” Ross said.
FDA Approval Procedures
According to the study, many deciding clinical trials conducted to achieve FDA approval involve fewer than 1,000 participants with follow-up monitoring of six months or even less. Safety issues frequently emerge years later after the new treatments have been used by a much larger number of patients, reports The Washington Post.
“No drug is completely safe, and during premarket evaluation, we are not going to pick up all the safety signals,” said Ross.
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Study Findings and Actions Taken
Study researchers reviewed 222 products FDA approved between 2001 and 2010 and evaluated them through February 2017. It was discovered that 32 percent of the medications required the FDA to take some kind of action to deal with safety issues that emerged after they had been approved and were readily available.
The FDA required 61 new black-box warning, the agency’s most serious safety alert placed on the medication’s packaging. The FDA issued 59 safety communications to alert doctors and consumers of newly identified concerns. Some products had more than one boxed warning added or safety alert issued, over the course of the study. In addition, three of the drugs were withdrawn from the market, according to The Washington Post.
According to the study, the median time for an FDA action was 4.2 years after approval of a new drug or treatment.
The founder and director of Scripps Translational Science Institute, Eric Topol, who was not involved in the study, said he was not surprised about the safety risks. Topol added, “The fact that it is one out of three of FDA-approved drugs is troubling.”
Topol noted that part of that problem is that clinical trials often hand-pick patients likely to produce the best results. “We don’t get a real-world representation,” he remarked.
Topol suggested that the FDA consider granting new medications conditional approval, then gather safety data from each patient to see, early on, whether a problem emerges. “Why not have a standard where we put every new drug under watch, and see if we could catch a problem before the drug is widely advertised?” he remarked.
The study revealed that the treatments most likely to be flagged for safety concerns were those granted approval under the FDA’s accelerated approval program, as well as medications for mental illnesses and those approved close to the deadline that had been set for the review.
David Kessler, the FDA’s commissioner chief during the administrations of George H.W. Bush and Bill Clinton said, “The competitiveness of the U.S. pharmaceutical industry is based on the fact that the drug is validated as safe and effective by the FDA. Any proposal that doesn’t require both will set back the industry’s competitiveness by 50 years.”
Cancer drugs are approved often within six months, according to data from the Friends of Cancer Research, an advocacy group. A comparison of 73 oncology drugs approved by both the FDA and the European Medicines Agency since 2003 showed the drugs were approved in half the time in the United States, according to The Washington Post.
An FDA spokeswoman said that, “FDA performs post-market monitoring to identify new safety information that may impact product labeling. 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 and assist in our mission to protect public health.”
Legal Advice and Information Regarding Pharmaceuticals
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