Study finds an increase in safety related label changes for new drugs approved through the FDA’s expedited regulatory pathways

A new article that was recently published in the British Medical Journal found an increase in safety-related label changes in drugs approved through the FDA’s expedited pathway.

The FDA has increasingly been granting faster reviews via expedited regulatory pathways that are allowed in an abbreviated development process.  Unsurprisingly, manufacturers’ use of these expedited development and review pathways has expanded in recent years.

In this new article, the authors analysed 15 years of data obtained from the Program on Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital and Harvard Medical School.  The article found that the drugs that received approvals through expedited routes had a 38% higher rate of safety-related label changes than drugs approved through non-expedited pathways.

While further research is required to identify the underlying issues that have led to this increased level risk of safety changes, the authors added that “Policymakers will likely need to ensure that these pathways are not overused, that there is sufficiently close post-approval monitoring of drugs approved through these pathways, and that patients and physicians are fully informed of the risks that accompany the widespread use of expedited development and regulatory review pathways in the approval of new drugs”.

The increase in safety label changes identified highlights the importance of active post-approval safety surveillance of all drugs and, specifically drugs approved through expedited development or review pathways.

This study had a number of limitations which should be borne in mind when drawing conclusions from this study.  These limitations include the exclusion of 29% of the expedited drugs through the matching process in the original sampling and the lack of a qualitative assessment of the clinical relevance of each labelling change”.  Nonetheless, the study’s findings provide interesting ‘food for thought’ for regulators and sponsors.

To read the full article, please click here.