Drugs

Phlow Awarded BARDA Generic Drug Contract

The HHS Biomedical Advanced Research and Development Authority has awarded an initial $354 million contract to Phlow, a Richmond, VA, drug manufacturing company, for advanced manufacturing of America’s most essential medicines at risk of shortage, including medicines for the Covid-19 pandemic response. The total contract value over 10 years could be $812 million, the company says.

Phlow says it and its partners already have delivered over 1.6 million doses of five essential generic medicines used to treat Covid-19 patients to the U.S. strategic national stockpile, including medicines used for sedation to help patients requiring ventilator support, medicines for pain management, and certain essential antibiotics.

The company says it also is building the country’s first Strategic Active Pharmaceutical Ingredients Reserve, described as a “long-term, national stockpile to secure key ingredients used to manufacture the most essential medicines on U.S. soil, reducing America’s dependency on foreign nations to support its drug supply chain.”

The company statement quotes White House Office of Trade and Manufacturing Policy director Peter Navarro as saying that “for far too long, we’ve relied on foreign manufacturing and supply chains for our most important medicines and active pharmaceutical ingredients while placing America’s health, safety, and national security at grave risk. We are now moving swiftly in Trump time to forge an American solution, one that leads with American ingenuity, American workers, and American factories all dedicated to ending our drug shortages and expanding drug manufacturing infrastructure for a healthy and secure future.”

However, an online Stat News post raises questions about Phlow co-founder and CEO Eric Edwards. The post says a Senate subcommittee found that Kaleo, a company founded by Edwards with his twin brother, raised the price of its Evzio opioid overdose antidote by more than 600% between 2014 and 2017, costing taxpayers more than $142 million.

The company also came to the attention of Sen. Charles Grassley (R-IA) in 2017 when it charged $4,500 for an EpiPen competitor.

“There is no suggestion that anything illegal occurred,” the story says. “Unlike some generic drug makers, Kaleo was never charged with price gouging, for instance. But the various moves occurred at a time when overdose deaths from opioids were accelerating. For this reason, the episodes raise questions about why the Trump administration tapped Edwards for such a crucial effort.”

Stat says the contract was praised by American Society of Health-System Pharmacists vice president of government relations Tom Kraus who said it “has the potential to be a game-changer that could significantly strengthen the U.S. drug supply chain and relieve many of the factors that contribute to drug shortages.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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