The US Federal Government’s Biomedical Advanced Research and Development Authority (BARDA) award of $354m to Phlow Corporation for the manufacture of COVID-19 medicines and other essential drugs has been touted by the Trump Administration as bringing pharmaceutical manufacturing back to the US. However, it is questionable why the $354m funding was awarded, seemingly without competition, to a new company that will need time to build production facilities rather than to an established contract manufacturing organization (CMO), says GlobalData, a leading data and analytics company.

Fiona Barry, Associate Editor of GlobalData PharmSource, comments: “The US currently relies on global supply chains to source its pharmaceuticals, with India and China manufacturing a huge proportion of the active pharmaceutical ingredients (APIs) and finished dosage forms for medicines taken by US patients, according to GlobalData’s Drugs by Manufacturer database. Attempting to sever these ties is part of the political ‘Buy American’ push being proposed by the Trump Administration for months, and recently by Joe Biden. However, given the US’s current reliance on imports, the country cannot switch to ‘onshoring’ US pharmaceutical manufacturing overnight. It would be a vast task that would take years and billions of dollars.

“The Trump Administration says that BARDA’s award in May is protecting Americans’ health, but Phlow and Civica Rx will need to construct facilities in Virginia before they can even begin to manufacture therapies to treat pandemic patients. AMPAC – owned by South Korea’s SK Holdings – already has US manufacturing facilities.”

Robby Demeria, Phlow’s Chief of Staff, told GlobalData PharmSource that Phlow’s facility will take 12–18 months to build.

Barry adds: “Such a lengthy delay raises questions about whether Phlow’s and Civica’s sites will be ready to manufacture a COVID-19 therapy in the required timeframe to address the pandemic. Using an already established CMO would have been a more sensible strategy to achieving faster scale-up of drug manufacturing for drugs that are in shortage.”

In the meantime, Civica Rx’s CEO, Martin VanTrieste, told GlobalData PharmSource that while Civica’s sterile injectable medicines manufacturing facility is being built, the company will outsource the manufacture of generic drugs to CMOs to build stockpiles of needed medicines.

Barry continues: “Another puzzling part of the contract is that it was awarded in a non-competitive manner. It received just one bid, according to the government website USAspending.gov. However, in an email to GlobalData PharmSource, Demeria denied that Phlow made the only bid for the grant.”