The FDA often approves new drugs with the caveat that the manufacturer complete postmarketing studies to confirm the safety and efficacy of these medicines. However, a new analysis indicates that barely half of these required studies are completed years later.
Steve Woloshin, MD, and Lisa Schwartz, MD, both of the Dartmouth Institute for Health Policy & Clinical Practice, and their colleagues looked at records and found 614 postapproval studies for new drugs that were required by the FDA in 2009 and 2010. Between 5 and 6 years later, only 54% of those studies had been completed, they reported in the New England Journal of Medicine.
But even more shocking, about 20% of those studies hadn’t even been started, and 25% were either ongoing or delayed — despite a 2007 law granting the FDA additional powers to mandate such studies. The law came in response to criticism that too many drugmakers weren’t completing the studies. The legislation also gave the FDA the authority to set timelines for when study designs and the studies themselves should be completed, as well as to levy fines on manufacturers and even rescind approval if those deadlines are not met.
The findings are a concern, given that many new drugs are approved based on trials with a relatively short duration. In addition, the Trump administration has been pushing for more rapid approval of drugs by relaxing approval standards. However, side effects may not become evident until a person is on a medication for some time, and that can only happen with longer duration post-marketing trials.
One example cited in the analysis is for the medication Suboxone (buprenorphine and naloxone), which is used to treat opioid dependence. In the clinical trials that supported approval, there were questions that the drug might lead to a heart issue. The authors say Suboxone’s manufacturer was given a year to submit a trial design and 5 years to complete the trial. As of July of this year, they say, the design – known as a study protocol –- had yet to be submitted.
The authors recommend that the FDA set shorter deadlines for completion of post-approval studies as one way of dealing with the problem. They also say the agency should use its power to impose penalties on drugmakers that fail to meet deadlines since to their knowledge, the FDA has never done so.