President Trump on Thursday signed an executive order dubbed 'buy American" that would require the government to buy essential drugs from U.S companies.
“If we’ve learned anything from the China virus pandemic, it is that we are dangerously overdependent on foreign nations for our essential medicines, for medical supplies like masks gloves, goggles and medical equipment like ventilators," White House trade advisor Peter Navarro told reporters.
The order will require the government to develop a list of essential medicines and buy them, as well as medical supplies, from U.S. companies instead of from foreign countries like China, Navarro said. He also contended that the order also will remove some of the regulations U.S. pharmaceutical manufacturers face and will fast-track the review process to make certain drug ingredients.
The FDA warned consumers of disruptions to the medical supply chain, including shortages of prescription drugs and critical medical products in the United States, early in the pandemic's outbreak. The United States has faced a shortage of some medicines as some of the pharmaceutical ingredients were made predominantly by China.
Industry reaction to the orders has been mixed with the Pharmaceutical Research and Manufacturers of America saying that the order imposes requirements that will distract the biopharma community from their focus on COVID-19 treatments and vaccines.
“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," said Stephen Ubl, PhRMA president and CEO. 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."
Last month, Trump announced a $765 million deal with Kodak to make ingredients needed to make generic drugs in response to the pandemic, and late last month Trump signed four executive orders designed to bring U.S. drug prices at least on par with their costs overseas. PhRMA said that taken together, the orders work against one another.
“With today’s ‘Buy American’ executive order, the administration effectively is taking the unprecedented step of mandating manufacturing of medicines in the United States," Ubl said Thursday. "Yet at the same time, through the ‘most favored nation’ executive order, the administration is creating a huge disincentive to invest in U.S. biopharmaceutical research and manufacturing. Together, the result is less investment in U.S. innovation and the potential for major long-term supply chain disruptions – the opposite of what America needs right now. None of these executive orders will help patients access or afford their medicines."
The National Community Pharmacists Association said that it would take a close look at the executive order and assess its impact on patients while noting that it thought moving away from dependence on other countries for pharmaceutical ingredients and products was a step in the right direction.
"The vulnerability of overreliance on sourcing the active ingredients of lifesaving generic medications from potential foreign adversaries has been highlighted during the pandemic," said Doug Hoey, NCPA president and CEO. "While we are encouraged that the president is considering how the United States can be less dependent on foreign nations for vital medications, changes to how prescription drugs are paid for at the pharmacy counter are essential to actually see lasting reform on the overreliance of overseas rivals. We look forward to reviewing this executive order in detail."
On the OTC side, the Consumer Healthcare Products Association noted that one of the main reasons the OTC drug manufacturers it represents have been able to meet U.S. demand without widespread shortages has been the global supply chain that already exists.
“While US consumers benefit from a highly efficient global supply chain for active pharmaceutical ingredients (APIs) and other ingredients needed to produce OTC medicines, CHPA and its members welcome the opportunity to discuss policy options to incent more domestic manufacturing for the APIs and ingredients," CHPA said. "However, we are concerned that any ‘Buy American’ mandate in the heat of a global pandemic could certainly lead to short-term supply challenges. We look forward to reviewing this order more closely and discussing future policy options with the Administration and with Congress.”