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Biden Looks to Boost Domestic Drug Manufacturing Amid Shortages

Amid widespread drug shortages, President Biden is outlining a plan to increase domestic production of essential pharmaceuticals — including by leveraging a defense law used to bolster countermeasures against COVID-19.

Why it matters: The number of drugs in shortage is higher than at any point in almost a decade, while U.S. drug manufacturers largely depend on overseas suppliers for active pharmaceutical ingredients.

  • Health care and national security experts for years have called for moving more drug manufacturing to the U.S., partly to guard against disruptions from a future pandemic or military conflict.

Driving the news: Biden announced Monday that he’ll use the Defense Production Act, among other measures, to create more essential medicines in the U.S.

  • The Korean War-era law, invoked by Biden and former President Trump during the pandemic, allows the president to direct private companies to produce materials and goods needed for national defense.
  • Biden will give the Health and Human Services Department authority to invest in medical products unrelated to the pandemic, including insulin, morphine, vaccines and ventilators, a White House official told Axios.
  • An official directive with more details will be released within a week, the official said.
  • HHS’ Administration for Strategic Preparedness and Response will oversee the effort, and the administration said it will invest $35 million into producing key starting materials for sterile injectable drugs.
  • “That supply chain is going to start here in America. We’re going to help ensure American families have reliable access to medicines they need,” Biden said Monday, as he announced around 30 other measures meant to head off shortages of key goods.

What they’re saying: Biden’s announcement is “quite positive,” said Marta Wosińska, senior fellow at the Brookings Institution’s Schaeffer Initiative on Health Policy.

  • The investment in key starting materials, as opposed to just active pharmaceutical ingredients, is crucial, she said.
  • “You won’t solve the geopolitical threat if you just move some of the middle of the supply chain to the U.S. but everything else still comes from the country from which we were trying to get away,” she noted.

Yes, but: Wosińska and other experts said more action is needed to address the fragile drug supply chain, which is often too reliant on a handful of manufacturers for drugs in high demand.

  • Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, said Biden’s announcement is “a start.”
  • “I’d like to see along the full manufacturing process more quality investment, because we know quality is one of the major issues behind drug shortages, whether domestic or overseas,” he said.
  • Permanently patching the drug supply chain will require a lot more funding, Wosińska said.
  • “If we want to have resilience in our supply chains, we will need to pay for it,” she said. “The administration can be creative, but they can only do so much until Congress basically decides to step in.”

Between the lines: Increasing domestic pharmaceutical production is a rare common thread between Biden’s and Trump’s health policy agendas.

  • Trump signed an executive order in August 2020 directing the government to reduce its reliance on other countries when purchasing essential medicines. Biden in 2021 issued an executive order to create a public-private consortium for increasing domestic production of essential medicines.

HHS will also create a new position for a supply chain resilience and shortage coordinator who manages efforts across the department.

  • That could be an opportunity for Medicare to explore using payment as a way to shore up the drug supply, Ganio said.
  • Medicare earlier this year proposed reimbursing hospitals for some of the cost of stockpiling critical medicines, but it recently said it won’t move forward with the idea at this point.

What we’re watching: The Department of Defense will soon issue a report aimed at reducing reliance on “high-risk” foreign suppliers, the administration also said Monday.

Source : AXIOS