Hahn Touts FDA Action on Drug Approvals but Data Tell a Different Story

Since February, the FDA has approved 361 generic drug applications and okayed nearly 300 manufacturing changes to help speed drugs to market for COVID-19 patients, FDA Commissioner Stephen Hahn said this week. He was touting the agency’s prompt response to the pandemic even though the agency’s numbers don’t back up that claim.

“We’ve significantly expedited the assessment of these type of changes,” Hahn said during the FDA’s virtual public meeting Tuesday to request public input on the reauthorization of the Generic Drug User Fee Amendments of 2012 for fiscal years 2023 through 2027 (GDUFA III).

The FDA data, though, tell a different story. By comparison, the agency approved 393 generic drug applications during the February-June period in 2019. In addition, Hahn said, the FDA has greenlighted 35 first-time generic drugs since February, both COVID-19 related and not. This compared with 44 first generic approvals for the same period in 2019.

Most of the manufacturing changes the FDA has approved since February have been requested to address disruptions from the COVID-19 pandemic, Hahn said. The agency does not provide comparable data on manufacturing changes.

“Even during this pandemic, we are on target to meet our GDUFA goal of assessing and taking timely action on at least 90 percent of generic drug applications, as we have since 2015,” he said.

Hahn said several of the drugs that have been approved have helped maintain the supply of medications for the most critically ill COVID-19 patients, including antibiotics, sedatives used on ventilated patients, anti-coagulants and pulmonary medications. — Suz Redfearn