FDA Researching Return of Drug Manufacturing to U.S.

FDA has awarded a research project to staff at the University of Maryland Smith School of Business to look at the risks to industry and government of returning drug manufacturing to the U.S. A statement from the university says the research will examine advanced manufacturing as a pathway to incentivize domestic drug manufacturing and will explore various frameworks for enterprise risk management.

The research comes from a realization during the Covid-19 pandemic that the U.S. had an outsized reliance on manufacturers for the raw ingredients for drugs sold in the U.S.

The statement says that as a result of the research, FDA will pilot a structure that would bring enterprise risk management concepts into CDER

The hope, says lead investigator Clifford Rossi, is that the research will help the agency and industry experts better understand the relative risks and economics associated with increasing pharmaceutical manufacturing in this country.