Sunday, August 14, 2022

Trump-era federal Covid contract recipient has yet to meet major deadlines

A pharmaceutical startup that received one of the largest-ever federal pandemic preparedness contracts championed by senior-level Trump White House officials has yet to fulfill its promise to bring cheap, generic drug manufacturing to the U.S.

In May 2020, the Biomedical Advanced Research and Development Authority issued a $354 million contract with the option to extend up to $812 million over 10 years to Phlow Corp., a Richmond, Va.-based company that had been created just a few months prior. It awarded Phlow an additional contract for $87 million in December 2021.

Phlow said it would be the first pharmaceutical manufacturer to use a novel production process to make generic drugs from start to finish more efficiently and cheaper, according to the agreement. The contract gave Phlow two years to begin making the active ingredients of drugs frequently in shortage or used to treat Covid-19 on U.S. soil. Two years later, Phlow was supposed to be making these drugs from start to finish.

But Phlow acknowledges that it has failed to deliver by the two-year deadline, casting doubt on its four-year targets. The company’s slow progress underscores how many new and sometimes untested companies won contracts during the chaotic first days of Covid — and the degree to which, two years later the federal government, now under the Biden administration — is still paying for products and services that have yet come to fruition. It also highlights how the allure of a more secure and less expensive supply chain can be an almost irresistible prize for U.S. health officials, eager to partner with enterprising CEOs who say they can make it happen.

Phlow has fulfilled some parts of its contract. BARDA tasked the company and its partners with immediately identifying a list of essential medicines at risk of going into shortage, and developing a surge capacity and domestic ramp-up of those drugs’ active ingredients. The company and its partners confirm that they have provided more than 2 million doses of essential medicines used to treat Covid-19 patients to the U.S Strategic Stockpile although Phlow declined to comment on which drugs these were, citing the terms of its contract.

But the company has provided very limited details on its main goal of developing continuously manufactured pharmaceuticals. “I’m just kind of scratching my head. What are you doing? Like seriously, what are you doing?” said Tony Quinones, the chief executive officer of Bright Path Laboratories Inc., a tech-bio company that uses artificial intelligence with continuous manufacturing to make pharmaceuticals.