Expedited Drug Approvals Associated With More Serious Safety Warning Updates: Study

New medications that it the market after approval under an accelerated regulatory process are more likely to require warning label updates for serious and potentially life-threatening side effects after consumers start using the drugs, according to the findings of new research. 

In a study published this month in the medical journal The BMJ, researchers indicate that a third of all new drugs approved by the FDA since 1997 went through an expedited process, and those drugs were almost guaranteed to have an average of at least one serious label warning update per year.

Researchers from Brigham and Women’s Hospital and Harvard Medical School in Boston looked at FDA public records on the approval of 382 new drugs from January 1997 through April 2016.

According to the findings, 35% of those drugs went through an expedited process, meaning they were fact-tracked to reach the market. Those drugs were almost certain (94%) to require a safety related label change every year. That compares with only a 68% chance of a label change for drugs that went through a more thorough approval process.

In addition, the expedited drugs had a 48% higher chance of requiring a black box warning or contraindication; the sternest label warnings the FDA can require.

“Expedited development and regulatory review pathways can accelerate the availability of new drugs, but drugs approved through these pathways are associated with increased safety related label changes after approval, particularly for the types of changes representing the highest risk warnings, “researchers concluded. “To inform appropriate policy interventions, additional research should explore the causal factors contributing to these different rates.”

This latest study comes following a number of similar reviews by independent researchers, including a study published in The BMJ in May, which looked at prospective controlled clinical studies for all drugs that were published after the FDA initially approved them between 2005 and 2012. All of the drugs included in the study were approved on the basis of a single pivotal clinical trial.

In June 2015, The BMJ also published an analysis that warned about numerous discrepancies in data submitted to the FDA by medical device manufacturers seeking premarket approval for heart devices.

Those discrepancies often included the number of participants varying in the actual study from the number reported to the FDA, substantially different results from similar FDA studies, and many of which were never peer reviewed.

Since drug makers and medical device makers often aggressively market new products after they are approved, espousing the benefits of their new treatment options, large numbers of unsuspecting patients end up being unwilling test subjects, without any disclosure that the product they are using was not fully vetted to ensure it is safe and effective.