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Biden to Order Review of Pharmaceutical Supply Chain

<ѻý class="mpt-content-deck">— Administration wants to "get ahead of future supply chain problems," official says
MedpageToday
Cardboard boxes labeled with American flags and MADE IN THE UNITED STATES roll down conveyors.

WASHINGTON -- President Biden will sign an executive order Wednesday afternoon directing federal agencies to study ways to secure the supply chain for pharmaceutical products and other manufactured goods, White House officials said Tuesday evening.

"Last year in the early months of the pandemic, we saw shortages of masks, gloves, and other critical personal protective equipment (PPE)," a senior administration official told reporters in a background briefing. "President Biden committed last year to directing the U.S. to take a comprehensive approach to securing supply chains, and the executive order the president will sign tomorrow afternoon kicks off that process."

"This is the first whole-of government approach to promoting the resilience of America's supply chains, from pharmaceuticals to foods," the official continued. "We're going to get out of the business of reacting to supply chain crises as they arise, and get into the business of getting ahead of future supply chain problems."

The executive order will direct 100-day reviews of supply chains for four critical sets of products: computer chips for items such as cars and phones; large-capacity batteries like those used in electric cars; pharmaceuticals and active pharmaceutical ingredients (APIs) -- "so we're not dependent on foreign competitors for key medical drugs and their inputs"; and critical minerals such as rare-earth minerals, the official said.

In addition, the executive order will direct six sector-specific reviews to be completed within one year, on the subjects of defense, public health and biological preparedness, information/communications technology, transportation, energy, and food production, said the official.

"Make no mistake: we're not simply planning to order up reports," the official said. "We are planning to take actions to close gaps as we identify them ... We expect by taking this type of comprehensive approach to supply chain resilience, we'll be able to strengthen our supply chains for the long term."

This effort won't be limited to federal agencies, according to another senior administration official. "The president is ordering agencies to consult with outside groups, and that includes consulting with industry, academia, workers, and communities," the second official said. "That is why the president is meeting with a bipartisan group of congressional leaders tomorrow, to listen and hear how we can all do our part to solve this problem."

In response to a question about how this executive order relates to earlier actions on increasing the vaccine supply, the first official said the two areas complemented one another. "In President Biden's first week in office, one of his early actions was signing an executive order around vaccine distribution and further increasing distribution of PPE," the official said. "A piece of that is a focused review looking at vaccine supply chains; we see what we're doing here with pharmaceuticals and APIs as very much complementary."

Whereas the earlier executive order was focused on "making sure we have vials and needles to get vaccines into arms, here what we'll be looking at is the pharmaceutical and API side of things with the goal of assuring we have long-term resiliency for key U.S. medicines," the official added.

Although bringing drug manufacturing home to the U.S. is often suggested as a solution to supply chain problems, that doesn't solve everything, Stephen Schondelmeyer, co-principal investigator of the Resilient Drug Supply Project at the University of Minnesota, said in December at a of the National Academies of Sciences, Engineering, and Medicine's Committee on Security of America's Medical Product Supply Chain.

"If we manufactured our entire supply of drugs in the U.S., it doesn't solve the problem if you put all the manufacturing in one facility and it gets wiped out by a hurricane," he said, recalling what happened when a hurricane hit Puerto Rico, the home of several medical product manufacturers. "Hospitals were scrambling to get things like normal saline. So simply bringing production back to the U.S. but concentrating it in one place doesn't solve the problem -- it just moves the problem."

Khatereh Calleja, president and CEO of the Healthcare Supply Chain Association, agreed. "We've got to focus on this very issue of geographic diversity," Calleja said. "Otherwise we're creating a risk when we create that concentration."

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    Joyce Frieden oversees ѻý’s Washington coverage, including stories about Congress, the White House, the Supreme Court, healthcare trade associations, and federal agencies. She has 35 years of experience covering health policy.