FDA Poses March Deadline for Reporting Unapproved Drug Use (2)

Drug companies would have until the end of March to tell the FDA which unapproved drugs they offered sick patients through the federal Right to Try law and whether they caused serious side effects under a proposed rule the agency released Thursday.

The rule is aimed to give the Food and Drug Administration a clearer picture of how patients are using experimental drugs through the law’s annual reporting requirements. It would also help provide the first comprehensive look at how effective the law has been at getting terminally ill patients access to the latest medications.

The Covid-19 pandemic has made ...