Virginia Bill Would Require Purchase of Local PPE

The Virginian-Pilot

When a Maryland-based biomedical company’s COVID-19 test kits got emergency use authorization by the US Food and Drug Administration, it faced a major question: Where to manufacture them?

Within days, MaximBio staff were in talks with Canon Virginia, a Newport News manufacturing company, thanks to a National Institutes of Health initiative called RADx. The program aims to increase domestic manufacturing of medical equipment and medicines to fight the coronavirus pandemic, according to Jonathan Maa, MaximBio chief operating officer.

Now his company’s test kits are being pumped out of Canon’s Newport News plant.

“We’re in full production,” said Ron Kurz, director of research and development at Canon Virginia, talking from the plant’s production floor Thursday.

Emergency materials to fight the pandemic, such as personal protective equipment, have been delayed  because of supply chain issues, leaving hospitals and emergency responders scrambling for materials  that have been increasingly sourced from overseas.

Despite the new emphasis on reshoring, and some successes, most companies that sought to fill the void of emergency materials have either gone out of business or scaled back their production lines, said Brett Vassey, president and CEO of the Virginia Manufacturers Association.

“We’ve learned nothing from the pandemic,” Vassey said. “Absolutely nothing.”

He said companies and agencies have reverted to buying the lowest-cost materials from overseas. But those lower costs come at a price — reduced quality and supply chain uncertainty. As the buyers flocked back to foreign products, it left domestic companies struggling to survive.

“For us, it’s an incredibly disappointing situation that so many companies made such an investment, not really to be rewarded, but because it was the right thing to do,” he said. “But the expectation was the state would do the right thing, and it just didn’t happen.”

However, a state law backed by a Hampton Roads politician could help turn the tide in the commonwealth.

Senate Bill 416 would require state agencies to prioritize procurement of PPE made in Virginia and/or the US if there are three or more bids for a contract. It also requires agencies to ensure whatever PPE is procured meets FDA quality standards. It received overwhelming bipartisan support in the House and Senate.

In 2020, nearly three out of four KN95 masks imported from China did not meet those standards, according to media reports. Production of PPE and other vital medical supplies is mostly sourced abroad, and that reliance was becoming a larger issue even before the pandemic, according to the U.S.-China Economic and Security Review Commission.

The Virginia bill was sponsored by Sen. Bill DeSteph, R-Virginia Beach, who also thinks the state and other buyers left new domestic producers “high and dry” when they returned to foreign sources for emergency materials.

To DeSteph, it’s not just about supporting companies that rose to the occasion, but it’s also about ensuring quality materials are available to American health care workers and first responders when they are needed.

But the bill’s future is still unclear.

Gov. Glenn Youngkin received the bill from the General Assembly and on April 11 sent it back to legislators with his recommendations. On April 27, the Senate decided not to take up Youngkin’s recommendations. The governor has until May 27 to veto or sign the bill, according to state code.

Youngkin’s recommendations would have had the bill go into effect July 1, 2023, instead of July 1 of this year, so there could be additional review, including on supply chain feasibility and the affect it would have on state agencies to acquire PPE.

DeSteph said he didn’t think the issue needed to be “studied to death,” and other legislators agreed, so they chose not to accept Youngkin’s recommendations.

Even if the bill were to become law, there are still some supply chain gaps.

The goal is to first produce 8 million testing kits for the Biden administration’s 1 billion testing kit goal and then expand operations, Maa and Kurz said.

“I think you’ve seen a lot of supply chain disruptions happen during COVID — getting things in from overseas becomes a huge challenge,” Maa said. “But having it here domestically helps smooth out that supply chain process.”