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www.fdanews.com/articles/197234-hhs-defends-selection-process-for-354-million-phlow-contract

HHS Defends Selection Process for $354 Million Phlow Contract

May 21, 2020

HHS is defending the bidding process that led to its $354 million four-year contract with a Virginia-based startup to manufacture active pharmaceutical ingredients (APIs) and finished drugs for emergency situations.

HHS said that it received a March 9 proposal from Phlow in response to an announcement issued by HHS’s Biomedical Advanced Research and Development Authority (BARDA) that was open to all companies.

Phlow also presented its proposal at a CoronaWatch meeting, at which companies pitch their proposals for HHS’ COVID-19 initiatives. The department said to date it has received 2,500 submissions and more than 250 companies have presented proposals.

Phlow was the only company that “presented an end-to-end solution” covering continuous manufacturing, addressing near-term COVID-19 drug shortages, and longer-term manufacturing of APIs and starting materials in the U.S., HHS said.

HHS said earlier this week that the Phlow contract may be boosted to a $812 million contract over 10 years, a stunningly large contract for an HHS manufacturing partnership with a private firm to produce drugs.

Future manufacturing of APIs and other materials will be jointly agreed to by the company, BARDA and the FDA, HHS said. The agreements and pricing will be “transparent and reviewed by BARDA on a monthly basis as stipulated in the contract,” the HHS spokesperson said.

A Phlow spokesperson said on Tuesday that the company bid for the contract “like everybody else” (DID, May 20). — Jordan Williams