Trump targets bolstering of US emergency drug reserve
The executive order, signed on 13 August, will see the active pharmaceutical ingredients (API) of around 26 'critical drugs' added to the SAPIR.
Trump has directed the Office of the Assistant Secretary for Preparedness and Response (ASPR) to curate the list of drugs whose APIs will be stored. The office of the ASPR is within the US Department of Health and Human Services (HHS) and is responsible for safeguarding drugs involved in the country's public health strategies.
The SAPIR was established in 2020 by the Trump administration in response to the Covid-19 pandemic. The reserve is supposed to have nearly two years' worth of medicine supply for the most important treatments approved by the US Food and Drug Administration (FDA), but a lack of investment means it has been near-empty for the past few years. The White House blames the Biden administration for failing to advance domestic production or fill the SAPIR, 'despite spending billions on supply chain initiatives'.
Trump has requested a shorter timeframe for how long the repository should be able to provide the 26 drugs in the event of an emergency. The ASPR is tasked with obtaining a six-month supply of the critical APIs.
It also instructed to update the 2022 list of 86 essential medicines, with a six-month supply planned too.
The executive order has asked the ASPR to preferentially source the API via 'domestically manufactured' means.
However, the office might have its work cut out to find these providers, given how reliant the US is on importing APIs. Of the manufacturers that produce APIs used in FDA-approved products, only 11% are based in the US. Around 43% of branded pharmaceutical API come from the EU.
In a statement, the White House said the move to fill the SAPIR with more drugs 'addresses supply chain vulnerabilities'.
A spokesperson added: 'Restoring capacity for domestic production of essential pharmaceutical products is essential to safeguarding national health and security against global supply chain disruptions.'
The SAPIR executive order is part of Trump's strategy to bolster domestic pharma manufacturing. This has mainly been mediated via tariffs and economic policies.
Last week, the FDA introduced a new scheme that will streamline the introduction of new pharmaceutical manufacturing facilities in the US. The PreCheck programme, unveiled by the agency on 7 August, comprises a two-phase approach to facilitate new US drug manufacturing facilities.
Big pharma has been responding to Trump's pressurised calls by outlaying significant funds to boost US manufacturing sites. Johnson & Johnson is set to invest $55bn over the next four years, including a $2bn biologics production site in North Carolina that promises to create 500 jobs. Roche outlaid a similar amount, planning $50bn worth of investment in the US, which will generate more than 1,000 jobs in new and expanded facilities.
"Trump targets bolstering of US emergency drug reserve" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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