Biden likely to sign bill that would crack down on China's chokehold on antibiotic supply

 The Senate on Monday passed (68-28) a wide-ranging, Biden-backed and already House-passed bill that would bolster American manufacturing, and try to crack down on China’s control of certain vital supplies like pharmaceuticals.

China quickly reached the forefront of API and generic drug manufacturing worldwide over the last decade, thanks in part to low labor costs, as the FDA’s data show the number of registered facilities making APIs in China more than doubled between 2010 and 2019.

Members of Congress on both sides of the aisle have warned of the national security implications of such an overreliance on China-made APIs and drugs, particularly as safety concerns have cropped over the years following inspections.

But the US is also equally reliant (if not more so) on India-made APIs and generic drugs. New USP data show that the number of manufacturing facilities with more than 10 active US-approved API products totaled 183 in India, 83 in Europe, and 35 in China. But for facilities making 30 or more active US-approved APIs, 114 are based in India, 45 in the EU, and 4 in China.

Still, the new COMPETES bill, which Biden previously supported, needs to have all its details ironed out between the House and Senate. But according to the Senate text, it would bring together the Department of Justice, the FTC and other federal agencies to investigate allegations of market manipulation and other potential violations of US laws by Chinese companies, such as controlling the supply of goods in critical industries of the US.

The first targeted industry listed by the bill is the pharmaceutical and medical devices industry.

The Senate bill’s text also calls on the US to work with its European counterparts to wean their overreliance on pharma products originating from China.

“The United States, European Union, and European countries should coordinate on joint strategies to diversify reliance on supply chains away from the People’s Republic of China, especially in the medical and pharmaceutical sectors,” the text says.

Both the Biden and former Trump administrations have sought to bring more pharma manufacturing back to the US, with hundreds of millions in funding for manufacturing companies like Phlow, but it remains to be seen how quickly this manufacturing can be brought onshore, or even the real extent of China’s control over these markets.

US-funded Phlow's first round of essential generics headed to children's hospitals, but they're made with foreign APIs

A 2019 op-ed in the Washington Post from California Democrat Reps. Anna Eshoo and Adam Schiff called China’s control of pharma manufacturing a national security issue, and discussed how China produces the ingredients found in almost every antibiotic and blood pressure medicine and hundreds of other drugs.

But the FDA previously explained that it still does not have the data to calculate the volume of APIs being used for US-marketed drugs from China, or India.

As former acting FDA commissioner (and current deputy commissioner) Janet Woodcock told a House subcommittee in 2019, “We do not know whether Chinese facilities are actually producing APIs, how much they are producing, or where the APIs they are producing are being distributed worldwide, including in the United States.”

https://endpts.com/biden-likely-to-sign-a-bill-that-would-crack-down-on-chinas-chokehold-on-the-antibiotic-supply/