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Law360 (March 23, 2020, 4:18 PM EDT ) Generic-drug makers are sounding the alarm over an anticipated "Buy American" executive order, saying that forcing federal agencies to buy U.S.-made drugs and medical supplies will disrupt pharmaceutical supply chains already stressed by the COVID-19 crisis.
Brand-name and generic-drug manufacturing has shifted abroad over the past few decades, and bringing that capacity back now will limit the availability of affordable medicines and increase the risk of drug shortages, the Association for Accessible Medicines said Friday.
The generic-drug association pointed out that its member organizations are already "working around the clock" to meet heightened demand for prescription medicines and over-the-counter drugs, some of which are used by COVID-19 patients to treat the disease's high fever and cough.
"Changes to the 'Buy American' provisions should not limit the ability of the U.S. government to provide medicines to veterans, soldiers and other patients during or after this time of national emergency," AAM said.
The warning comes after administration trade adviser Peter Navarro told Fox News that the White House was preparing an executive order forcing several federal agencies to prioritize purchasing U.S.-made drugs and medical supplies.
"We're going to put into motion a long-term trend to bring our pharmaceuticals, our medical equipment, our medical supplies home to domestic soil," Navarro said March 15.
According to the AAM, generic-drug makers fill 90% of American consumers' prescriptions. However, 60% of all generic finished dosage form facilities and 87% of all generic active pharmaceutical ingredients facilities are located abroad, where production costs are cheaper.
Companies will need a minimum of 18 months to secure the U.S. Food and Drug Administration's approval to shift production from one facility to another. And building an entirely new U.S. production center would require five to 10 years, AAM said.
Bringing all the overseas generic manufacturing and production capabilities back to the U.S. "is simply not feasible in the short-term," AAM said.
Brand-name drugmaker organization the Pharmaceutical Research and Manufacturers of America also said Monday that a diverse supply chain is critical to the pharmaceutical industry's ability to develop treatments.
"Geographic diversity in the pharmaceutical supply chain enables manufacturers to make adjustments as needed to avoid shortages, which is especially important during national disasters and global pandemics," PhRMA said.
Representatives for AAM and PhRMA didn't immediately respond to requests for comment Monday.
--Additional reporting by Alex Lawson. Editing by Alanna Weissman.
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