Michael Halaiko and Alex Moylan, shareholders in the law firm of Baker Donelson, discuss the Trump Administration’s recent executive orders on domestic production of critical medicines.
A pair of executive orders issued by President Trump address, in one case, improvements in the safety and security of biological research, and in the other, promoting domestic production of critical medicines.
The second order has a twofold aim, says Halaiko: to reduce regulatory barriers and promote expansion of domestic manufacturing facilities for active pharmaceutical ingredients (APIs) and finished drug products, and to increase unannounced inspections of foreign manufacturers, with the additional cost paid for by an increase in inspection fees.
Moylan says the Administration is addressing perceived inequities in the treatment of domestic versus foreign manufacturers. The executive order seeks to make it easier to stand up or expand plants in the U.S. It establishes a series of deadlines, ranging from 90 to 180 days, for various federal agencies, including the Food and Drug Administration, Environmental Protection Agency, Office of Science and Technology and Army Corps of Engineers, to take actions to comply. They include updating regulations on domestic pharmaceutical manufacturing, speeding up approval of new domestic facilities, expanding technical advice programs for drug manufacturers, boosting enforcement of data reporting, and streamlining the environmental permitting process.
For the pharmaceutical industry, the executive orders present both opportunities and compliance issues. Moylan says they will require a major adjustment by drug manufacturers, altering a supply chain that has traditionally depended on offshore sourcing for a significant portion of drug ingredients and finished products. “This is a global market,” she says. “It can’t change overnight.”