Medically Necessary: Infrastructure plan directs billions to health care

President Joe Biden and Vice President Kamala Harris and Secretary of Transportation Pete Buttigieg meet with bipartisan members of the House to discuss infrastructure. (Official White House photo by Adam Schultz)

This is an excerpt from the April 1, 2021 edition of Medically Necessary, a health care supply chain newsletterSubscribe here.

The plan: The infrastructure plan proposed by the White House this week includes billions of dollars for the health care industry.

  • The White House’s infrastructure plan is just a proposal. Congress will have to approve any infrastructure spending. 

There are few calls to invest directly in the health care supply chain, but some proposals could affect how and where logistics companies are delivering medical products to patients or health care providers.

Top line: The infrastructure plan is light on specific details, but here are a few proposals that could affect the health care supply chain.

Pandemic countermeasures: The plan includes $30 billion over the next four years for investments in manufacturing, research and development and other pandemic countermeasures.

  • The plan specifically calls for investments in the National Strategic Stockpile and bringing manufacturing of active pharmaceutical ingredients back to the United States. These are the plan’s most direct investments in the health care supply chain.
  • In a story for Bloomberg Law, industry experts said the money could be used to make the National Strategic Stockpile more intelligent or to research a universal flu or coronavirus vaccine. 
  • In December, former Health and Human Services Assistant Secretary Robert Kadlec told Bloomberg Law reporter Shira Stein the future of the National Strategic Stockpile will be about building better visibility into the supply chain rather than simply increasing the number of products sitting in warehouses.

Expand access to home or community-based care: The plan directs $400 billion to this broad category of health care services, which offers help to older people or people with disabilities for everyday activities like getting dressed or bathing. 

  • In a story for Bloomberg Government, industry experts said they hoped the money would be used to move people off of waiting lists for home care. That could increase the number of people who need drugs or medical products at home.
  • Home and community-based care includes providing patients living at home with medical equipment, pharmacy services and meal delivery. 
  • The infrastructure plan doesn’t specifically break down spending for this goal. But this section of the plan focuses heavily on improving wages for caregivers rather than spending on physical infrastructure.

Medical research: The plan calls for $50 billion of investment in research infrastructure for a variety of fields, including biotechnology.

  • The plan would create a technology directorate within the National Science Foundation focusing on “fields like semiconductors and advanced computing, advanced communications technology, advanced energy technologies and biotechnology.”

Johnson & Johnson mix-up will slow down future deliveries

The mistake: Workers at a manufacturing plant in Maryland ruined up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine, The New York Times reported on Wednesday.

  • Workers at the plant operated by contract manufacturer Emergent BioSolutions mixed up ingredients for the Johnson & Johnson and AstraZeneca vaccines, which are both being produced at the facility, according to the Times.
  • “Human errors do happen. You have checks and balances,” White House COVID-19 adviser Anothony Fauci told CBS News on Thursday. “The good news is that it did get picked up. … Nothing from that plant has gone into anyone.”

The response: In a statement, Johnson & Johnson said it identified the problem during a quality check. 

The plant where the problem occurred hasn’t been authorized by the Food and Drug Administration to distribute the vaccine yet, so none of the contaminated doses made it into a vial.

  • “Johnson & Johnson is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing,” the company said in the statement. “These steps will enable us to safely deliver an additional 24 million single-shot vaccine doses through April.”

The company still expects to deliver 100 million shots through the first half of 2021.

Delays: The FDA is now investigating the problem, which could delay the Emergent plant’s approval and slow down delivery of future doses, according to The New York Times.

  • So far, Johnson & Johnson has been making the drug substance at its own manufacturing plant in the Netherlands, according to The Wall Street Journal.
  • Producing the drug substance usually takes about two months, Johnson & Johnson’s vice president of medical affairs told lawmakers in February.

If the FDA investigation delays approval of Emergent’s Maryland plant, Johnson & Johnson doesn’t have many other options for producing the drug substance. 

For comparison, AstraZeneca has more than 10 sites that can produce drug substance, according to the consumer advocacy group Public Citizen. Moderna only has two sites that produce drug substance, according to congressional testimony

Backstory: The FDA’s Center for Drug Evaluation and Research issues dozens of warning letters related to manufacturing hiccups every year.

  • The agency issued 84 warning letters to drug manufacturers in 2019. Nearly two-thirds of those warning letters were related to manufacturing problems, according to a public database

The Associated Press reported on Thursday that FDA inspectors have previously criticized quality control procedures at the Emergent facility where the mistake happened.

Final thought: Producing similar products at the same site under intense pressure requires more poka-yokes, foolproof processes to guard against human error, supply chain researcher Prashant Yadav wrote on Twitter.

  • “Pokas happen and are no one’s fault,” he wrote. “If we learn from them in the right way & develop good (processes) for the future, then we advance manuf sci.”