Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices

Regulatory NewsRegulatory News
| 07 August 2020 | By Michael Mezher 

President Donald Trump on Thursday signed an executive order aimed at onshoring the production of essential drugs, medical devices and critical inputs for those products to reduce US reliance on foreign manufacturing and promoting federal procurement of domestic goods.
Speaking at a Whirlpool Corporation manufacturing plant in Clyde, Ohio, Trump said the US is too dependent on foreign medicines and supplies. “As we’ve seen in this pandemic, the United States must produce essential equipment, supplies and pharmaceuticals for ourselves,” Trump said.
Industry groups were quick to push back against the order, claiming it could drive up prices and create “chaos” in the pharmaceutical supply chain.
Pharmaceutical Research and Manufacturers of America (PhRMA) President Stephen Ubl said the order, and Trump’s recent executive orders aimed at drug pricing, “contradict and undermine each other.”
“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 US 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.
Jeff Francer, interim CEO of the Association of Accessible Medicines, defended the resilience of the global pharmaceutical supply chain amid the pandemic and warned that the low generic drug prices in the US poses a bigger threat. “Without addressing the undervaluation of generic and biosimilar medicines in the US with sustainable market supply plans, we simply cannot secure the domestic market and supply chain with scale and sustainability,” he said.
In consultation with FDA, federal agencies have 90 days under the order  to “develop and implement procurement strategies, including long-term contracts,” to boost domestic manufacturing.
FDA has an even tighter deadline of just 30 days to develop an initial list of essential medicines, medical countermeasures and critical inputs and 90 days to finalize the list. The US Trade Representative is tasked with excluding coverage of products on the list from free trade agreements and the World Trade Organization Agreement on Government Procurement.
However, the order provides several workarounds for agencies to procure essential products internationally if domestic procurement would not be in the public interest; if the products are not made in the US or are not available from domestic sources in sufficient quantity or quality; or if costs would increase by more than 25% unless a higher percentage is otherwise required by law.
The order would not apply to products deemed necessary to respond to declared emergencies or major disasters under the Public Health Service Act, Stafford Disaster Relief and Emergency Assistance Act, or the National Emergencies Act.
FDA and the US Department of Health and Human Services (HHS) are also tasked with taking action to shore up supply chain vulnerabilities within 180 days. Actions called for in the order include requiring information about the source and scarcity of finished drugs and devices and their critical inputs; sharing records on supply chain security with other departments and agencies; and making recommendations to the president on any changes in law or regulation needed to support the objectives of the order.
Additionally, FDA is instructed to accelerate the approval or clearance of domestically manufactured products and inputs and issue guidance on developing advanced manufacturing techniques.
The order also has two provisions related to facility inspections. The first instructs FDA to increase the number of inspections and unannounced inspections for manufacturers of essential medicines, medical countermeasures and critical inputs in other countries, while the second calls on FDA to refuse admission of such products when an inspection is refused or unreasonably delayed.


© 2022 Regulatory Affairs Professionals Society.

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