US in Emergency Plan to Produce COVID-19 Treatments

20.05.2020 -

The administration of US president Donald Trump has had a rocky relationship with the country’s pharmaceutical industry since taking office in 2017. The move this week to award Richmond, Virginia-based start-up drugmaker Phlow Corporation a four-year, $354 million contract to lead a nationwide effort to produce therapeutics for COVID-19 took the industry by surprise.

Under the terms, Phlow’s contract can be expanded up to 10 years to a total value of $812 million, which US pharma journals noted places it among the most expensive deal in the history of US emergency preparedness efforts.

In a statement, the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS), said the production facilities to be built at Richmond – as well as other as yet unannounced US locations – would expand national capacity for medicines needed during the pandemic as well as in future emergencies.

The Virginia facility, for which no start-up date was announced, would manufacture unspecified generic medicines and active pharmaceutical ingredients (APIs) and the chemical compounds needed to produce the treatments.BARDA said the government and Phlow are developing a prioritized list of APIs and finished medicines critically needed by healthcare systems for the COVID response.

To lower production costs, reduce waste and improve yields of these ingredients, HHS said the drugmakers would use advanced manufacturing methods such as flow chemistry and also complete a technology transfer of novel continuous manufacturing processes to organizations or businesses designated by the US government.

To meet the targets, Phlow is working with CivicaRx, a generics producer started by US hospitals to combat rising drug prices and API supplier AMPAC, among others. CivicaRx and its partners would be responsible formanufacturing the finished dosage forms of essential medications, including vials and syringes. 

Phlow said its partnership with HHS and its sub-units had "immediately enabled" the company to deliver 1.6 million doses of five generic drugs used to treat hospitalized COVID-19 patients, including sedatives for patients on ventilators, to the US. Strategic National Stockpile, which it would be charged with rebuilding.

Reducing dependence on foreign supply chains

US news media commented that the creation of a national manufacturing initiative opens a new front in the Trump administration's war on foreign drug supply as the novel coronavirus pandemic continues to expose fragilities in the global manufacturing industry.  Statements by Both HHS and Phlow pointed in this direction.

“Working with the private sector, HHS is taking a significant step to rebuild our domestic ability to protect ourselves from health threats by utilizing American-made ingredients and creating new American jobs in the process,” Secretary Alex Azar (a former Eli Lilly executive) said.

HHS also commented that the majority of APIs or their precursor chemical ingredients for critical medicines come from outside the US, and they are “typically manufactured using slower, less efficient processes.” What’s more, the cabinet-level department said, “shipping the ingredients or finished drugs to the US also adds time.”

More than 80% of APIs and chemical ingredients used in the US to manufacture generics and over-the-counter drugs are produced abroad, the majority in China and India, Eric Edwards, co-founder, president and CEO of Phlow said. “"In the midst of this pandemic, America needs a reliable source of high quality, domestically manufactured, affordable pharmaceuticals and their key ingredients.”

In early April, Trump criticized India for not immediately ending its export ban for malaria treatment hydroxychloroquine, a drug he touted as a potential "game-changer" to treat COVID-19. This week, the president and this week asserted has been taking it as a prophylactic.

New front in the hydroxychloroquine battle

Trump’s claim that he is now taking hydroxychloroquine himself and suggesting that others do the same also opened up a new front in the war between the White House, the scientific community and the media.

After initially relaxing its rules on the use of the malaria drug to treat COVID-19, the Federal Health and Drug Administration (FDA) has since rethought its stance on taking hydroxychloroquine before the completion of clinical trials, which so far have produced no evidence of its effectiveness in treating the new virus.

In particular the remark that others should take the drug triggered criticism from the Fox broadcasting network, which initially had strongly pushed Trump’s game-changer message. Moderator Nick Cavuto urged a nationwide audience not to try it “because it can kill you.”