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Trump to Faucet New Firm to Make Covid-19 Medication within the U.S.

trump to faucet new firm to make covid-19 medication within the u.s. - trump to faucet new firm to make covid-19 medication within the u.s. -

WASHINGTON — The Trump administration will announce on Tuesday that it has signed a $354 million four-year contract with a brand new firm in Richmond, Va., to fabricate generic medicines and pharmaceutical substances which are wanted to deal with Covid-19 however are actually made abroad, principally in India and China.

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The contract, awarded to Phlow Corp. by the Biomedical Superior Analysis and Growth Authority, meshes President Trump’s “America First” financial guarantees with issues that coronavirus remedies be manufactured in the US. It might be prolonged for a complete of $812 million over 10 years, making it one of many largest awards within the authority’s historical past.

It was unclear why the administration decided to award such a large contract to a new company when an entire industry exists — known as contract manufacturing — that makes drugs for other companies. However, manufacturers that operate in the United States generally make finished products using raw ingredients imported from elsewhere. They do not make the raw ingredients.

In an interview, Dr. Eric Edwards, the chief executive and president of Phlow, described the company as a “public benefit corporation” that was dedicated to having a social impact, and he said his firm also intended to create “the nation’s first strategic active pharmaceutical ingredient reserve” — in essence, a stockpile for pharmaceutical ingredients to be used in the event of drug shortages or an emergency.

“There are not a lot of people wanting to bring back generic medicine manufacturing to the United States that has been lost to India and China over decades,” said Dr. Edwards, who described himself as a “serial entrepreneur” as well as a physician. “You need someone like the federal government saying this is too important for us not to focus on.”

In a statement that the Trump administration plans to release Tuesday morning, Mr. Trump’s health secretary, Alex M. Azar II, called the initiative “a significant step to rebuild our domestic ability to protect ourselves from health threats.”

Martin van Trieste, the chief executive of Civica Rx, is also on Phlow’s board. And another board member, Rosemary Gibson, is a senior adviser at the Hastings Center, a nonpartisan bioethics institute, who has frequently written and testified about the dangers of the United States’ reliance on Chinese drug manufacturing.

Dr. Edwards said his company would focus on “critical care medicines used to treat hospitalized patients with Covid-19,” including “medicines that are used for sedation to help patients requiring ventilator support, pain management and certain essential antibiotics.” Production has already begun at an Ampac facility, he said, while Phlow builds new plants.

China is the main global supplier of the raw ingredients used in many common drugs, including antibiotics like penicillin and painkillers like ibuprofen and aspirin.

In recent years, observers like Ms. Gibson have warned about dependence on China for raw pharmaceutical ingredients, pointing to the widespread recalls in 2018 of the blood pressure drug valsartan that were traced to problems at a single Chinese factory that made the drug’s active ingredient, which was contaminated with a possible carcinogen.

Dr. Edwards said Phlow was incorporated in January, though he began working on it last year, before the emergence of the coronavirus. The aim, he said, was “strengthening America’s supply chain and manufacturing American generic medicines at risk of shortage.” He planned at first to use advanced manufacturing technology to produce generic drugs for children. But he switched gears, he said, when the pandemic emerged, and responded to a request from the Biomedical Advanced Research and Development Authority for proposals to use advanced manufacturing to assist in the Covid-19 response.

A spokesman for Phlow said Monday night that “Dr. Edwards departed Kaléo on good terms over one year ago and had no oversight of drug pricing during the end of his tenure.”

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