Analyst: FDA's RTF letters suggest agency is getting tougher

Once upon a time the FDA reserved the bulk of its refuse-to-file letters for little biotech companies with little experience or know-how in the field of new drug applications. But after reviewing the FDA's letters over the past two years, Leerink Swann analyst Howard Liang found that some of the biggest pharma companies in the business have been subjected to embarrassing rejections. And he suggests that the rejections suggest the new FDA commissioner, Margaret Hamburg, is getting tougher. "While it is not possible to firmly conclude that the pace of RTFs has increased statistically due to a relatively small sample size and lack of disclosure of all RTFs, the fact that even the most experienced companies receive RTFs suggests a change at the FDA." Report

Suggested Articles

Xcovery's ALK inhibitor shrank tumors in 75% of lung cancer patients, compared to 67% for Pfizer's Xalkori, the first FDA-approved drug of that class.

The FDA accepted the regulatory filing for Biogen's once-failed Alzheimer's drug, aducanumab, with plans to decide its fate by March 7, 2021.

Alexion named a chief diversity officer, while COVID-19 vaccine player has two new members of its C-suite.