FDA Efforts to Increase Generic Approvals Have Little Effect

Although a JAMA Network Open report found that the U.S. Food and Drug Administration (FDA) gradually increased its approvals of generic drug applications between July 2016 and December 2018, there was no evidence that this has bolstered competition or alleviated shortages.

“Our results suggest that there have not yet been noticeable effects of the FDA’s initiatives to expand approvals for generic drugs at risk for price spikes and shortages,” the authors said.

The FDA began boosting generic approvals as a strategy for lowering the cost of medications because lower-cost generic drugs account for approximately 90% of prescriptions. Two years ago, the agency released a list of brand-name drugs with expired patents and limited to no competition to spur development. In addition, the FDA has been prioritizing reviews of applications in which there are fewer than three generic approved alternatives to the corresponding brand-name medicine.

Although the researchers found little evidence suggesting an improvement, they noted that it may be too early to measure results. “It will take time for the FDA’s policies to lead to observable changes – the policies were initiated in 2017 and predominantly focused on generics that had limited competition,” Joseph Ross, MD, MHS, lead author of the report and professor of medicine and public health at Yale University, told STAT.

Source: STAT, October 14, 2019.