Trump Signs Order Requiring U.S. Government to Buy Drugs From U.S. Companies

In a move that’s likely to shake up the entire U.S. drug supply chain, President Trump signed an executive order yesterday directing the federal government to buy “essential drugs” from domestic companies.

The new order seeks to reverse the trend of increasing U.S. dependence on overseas sources of drugs and active pharmaceutical ingredients, notably China.

Giving no timeline for implementation, it directs the FDA to develop a list of drugs deemed “essential,” and then requires federal departments to limit procurement to U.S. drugmakers.

The order also instructs HHS to accelerate approval of FDA applications for drugs developed in the U.S., and it directs the FDA and the Environmental Protection Agency to streamline regulatory clearances for advanced manufacturing facilities in the U.S.

Under the order, federal officials could source drugs from abroad if a product is not available in sufficient quantities in the U.S. or if the purchase would raise procurement costs by 25 percent.

Commenting on the “Buy American” order, PhRMA president and CEO Stephen J. Ubl,  said that it “creates even more barriers to ongoing biopharmaceutical manufacturing and innovation.”

“The administration is forcing biopharmaceutical companies to shift their critical attention and resources away from COVID-19 work to focus on making substantial changes to their business models necessary to comply with this and other recent executive orders. Increasing U.S. manufacturing of medicines is a laudable goal, but it cannot happen overnight and should not come at the expense of medical innovation or Americans’ access to the medicines they need,” Ubl said.

He said the executive order “could disrupt the global pharmaceutical supply chain, jeopardizing our ability to respond to the current crisis and potentially leading to major long-term supply chain disruptions, including shortages. Rather than government mandates, we should look for policies that enable more domestic manufacturing without putting the stability of pharmaceutical supply chains at risk.”

Association of Accessible Medicines (AAM) Interim CEO Jeff Francer said that without addressing the undervaluation of generic and biosimilar medicines in the U.S. with sustainable market supply plans, “we simply cannot secure the domestic market and supply chain with scale and sustainability.”

The Biotechnology Innovation Organization (BIO) said it will closely follow how the order is implemented, adding that “hasty policy decisions could significantly disrupt a system that has worked extremely well for both patients and drugmakers and harm access to medicines when Americans may need them the most.” — Jordan Williams