Last month we wrote about an executive order that renewed attention to the problem of drug shortages and the FDA’s inability to fix them. This month, both the Government Accountability Office (GAO) and a U.S. Senate Committee provided more ammunition for granting greater authority for the FDA to address the problem. There’s no real news, but there are more and louder authoritative voices to prompt positive change.
As recounted on FDA Law Blog, Marcia Crosse, GAO Director of Health, told the Senate Committee on Health, Education, Labor and Pensions that the FDA is “constrained in its ability to protect the public health from the impact of [drug] shortages.”
Bills in both the Senate and House of Representatives, and an FDA interim rule to enable the agency to improve its collection and distribution of drug shortage information to physician and patient organizations and to work with manufacturers to respond to potential drug shortages speak to the government’s interest in solving the problem.
Please see full publication below for more information.