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Trump's US-Made Drug Decree Sows Uncertainty In Industry

August 7, 2020, Law360

Jennifer Plitsch spoke with Law360 about a presidential executive order calling for federal agencies to be required to buy domestically produced versions of medicines. Ms. Plitsch says, “Those will be significant, certainly at the outset [of the order going into effect], in light of the current market.”

She adds that under the definition of "produced in the United States" used in the order, where both critical inputs and the final production must be domestic, the percentage of medicines and devices that will ultimately end up on the FDA's list that are currently made domestically will likely be "very, very low."

Although the executive order directs the U.S. Environmental Protection Agency to find ways to streamline approvals for new facilities, including accelerating siting and permitting approvals, those processes are not typically a major barrier anyway, she says. Financial factors are a more significant concern, but the order doesn't make any federal money directly available to assist with establishing new facilities. “There will likely need to be additional incentives to construct new facilities in the United States, particularly when there is no existing indication that global production is insufficient to meet the needs of U.S. patients.”

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