This is an excerpt from Medically Necessary, a health care supply chain newsletter. Subscribe here.
The promise: Over the last several months, lawmakers from both parties have introduced more than a dozen bills to improve the health care supply chain following failures during the COVID-19 pandemic. Few have made much progress, but several have bipartisan support.
Many of the bills propose similar solutions such as studies on the causes of supply chain issues and support for domestic manufacturing.
At a Senate committee hearing last week, a group of experts said the U.S. could prepare the supply chain for future pandemics by strengthening the Strategic National Stockpile and encouraging domestic manufacturing of drugs and supplies.
The problems: During the hearing, senators recounted scenes of nurses sewing their own masks and lamented the country’s reliance on foreign manufacturers to produce drugs and medical supplies.
Sen. Rob Portman, a Republican from Ohio, blamed supply chain failures on a “failure of imagination.” Sen. Gary Peters, a Democrat from Michigan, claimed the Trump administration mismanaged the situation.
Both said they hoped the hearing would lead to legislation that would prevent similar shortages in future pandemics.
The solutions: Researchers, trade groups, hospitals and private companies offered a range of potential solutions at the hearing, ranging from raising tariffs to creating new government agencies.
Nearly all agreed that increasing the geographic diversity of the health care supply chain and increasing visibility would make it more resilient.
A better stockpile: Rob Handfield, a professor of supply chain management at North Carolina State University, said the federal government should add more flexibility to the Strategic National Stockpile, a supply of emergency medical products maintained by the federal government.
The federal government failed to replenish the national stockpile after the H1N1 pandemic in 2009, meaning many products had already expired when they were needed last year.
In written testimony, Handfield stressed that a better stockpile isn’t necessarily bigger. Instead, he suggested using military or Veterans Affairs hospitals to extend the stockpile.
“We need to move away from the idea of simply increasing the Strategic National Stockpile and think more in terms of a ‘Strategic National Sourcing’ framework,” he wrote.
Military and VA hospitals could use stockpile supplies before they expire, he said, avoiding waste. The extended stockpile would need to be continually replenished, ensuring it always has fresh supplies.
However, achieving that goal would require much more visibility into the supply chain of medical products.
More visibility: Stephen Schondelmeyer, a researcher focused on drug shortages at the University of Minnesota, said increasing visibility also could make the drug supply, which constantly experiences shortages, more reliable.
Currently, the Food and Drug Administration doesn’t have much information about the volume of drugs or drug precursors produced in foreign countries.
Schondelmeyer said building a detailed map of the pharmaceutical supply chain would help government agencies and health care companies forecast shortages and adjust supply chains to avoid them.
“Obviously, we need to shift from a ‘fail-and-fix’ framework to a ‘predict-and-prevent’ paradigm,” he wrote.
Most of the factories producing pharmaceuticals for U.S. patients are located in other countries, which is part of the reason supply chains are so opaque.
Domestic manufacturing: Schondelmeyer said the U.S. should also consider encouraging manufacturers to produce more drugs domestically.
“The re-shoring of some pharmaceutical production may be beneficial economically and logistically,” he wrote. “However, we must also remember that diverse geographic locations for supply may be more resilient.”
Last year, Peters introduced legislation that would require foreign drug manufacturers to submit more information to the FDA, and a companion bill offered grants, loans and expedited approvals to domestic drug manufacturers.
Sen. Jacky Rosen, a Democrat from Nevada, said she was also working on legislation to encourage nonprofit manufacturers to produce drugs in the U.S.
Kimberly Glas, CEO of the trade group National Council of Textile Organizations, argued that the country’s reliance on foreign manufacturers of PPE also poses a major risk for the health care supply chain.
But she said PPE manufacturers in the U.S. would need lots of support from the federal government to compete with Chinese factories.
“We’re going to need to diversify supply chains moving forward,” she said. “We need to show a demand signal to the industry. There needs to be incentives for hospitals … that want to purchase USA-made products.”
The bills: Many of the recent health care supply chain bills echo themes from President Joe Biden’s executive orders related to supply chains or the administration’s infrastructure plan, such as calls to investigate supply chain vulnerabilities.
One bill, called the Endless Frontier Act, aims to create a Department of Commerce program to investigate supply chain issues for critical industries, such as health care. Another seeks to create a similar program within the White House.
Other bills seem to focus more directly on issues identified by witnesses during the hearing last week.
Last week, a bipartisan pair of senators proposed reforms to make the Strategic National Stockpile more flexible. Another bill hopes to create incentives to convince manufacturers to produce more PPE in the U.S.
What’s next? So far, the House has passed one bill that would expand the president’s powers under the Defense Production Act. Several other bills have bipartisan support and appear to be moving forward.
The Endless Frontier Act has more than a dozen co-sponsors from both parties and legislators have been actively debating its language.
Some other proposals have fewer co-sponsors and haven’t received as much attention. However, Portman said the recommendations offered at the recent hearing will help legislators refine those bills.
“I think we owe it to those who lost their lives during this pandemic and all the disruptions it has caused to get this right,” he said at the hearing.
FDA relaxes storage requirements for Pfizer vaccine
An Air Force staff sergeant places a batch of COVID-19 vaccines inside a freezer at Joint Base McGuire-Dix-Lakehurst, New Jersey. (Photo: Department of Defense/Jake Carter)
The decision: The FDA will allow health care providers to store thawed, undiluted vials of Pfizer’s COVID-19 vaccine at refrigeration temperatures for up to one month. Previously, those vials could only be stored at refrigeration temperatures for five days.
According to an FDA fact sheet, frozen vials will still be shipped to vaccine administration sites at ultra-cold temperatures, between minus 112 degrees and minus 76 degrees Fahrenheit. In February, FDA allowed health care providers to transport frozen vials at higher temperatures.
Once frozen vials arrive, health care providers thaw them in a refrigerator, where they are stored before use.
The impact: The decision should make it much easier for health care providers to keep the vaccine on hand for patients.
“This change should make this vaccine more widely available to the American public by facilitating the ability of vaccine providers, such as community doctors’ offices, to receive, store and administer the vaccine,” Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research, said in a statement.
The FDA’s decision means all of the COVID-19 vaccines approved in the U.S. can be stored for some amount of time at refrigeration temperatures.
Modderna’s COVID-19 vaccine is shipped at very low temperatures but can be stored in a refrigerator for up to 30 days before its first use. Johnson & Johnson’s COVID-19 vaccine can also be stored at refrigeration temperatures.