- Jeff Shuren, director of FDA's Center for Devices and Radiological Health, told a House subcommittee on Wednesday that financial support for diagnostics companies is critical to ensure the U.S. does not face testing shortages during the next public health crisis, like the country has experienced in the COVID-19 pandemic.
- Shuren, who testified during a hearing on the fifth Medical Device User Fee Amendments (MDUFA), said in order to avoid future diagnostics shortages the federal government must "pre-position" test manufacturers in advance of a public health emergency. "Have contracts with them so that when they're asked, they're set to do it. And, you do it with manufacturers who make this kind of technologies and they can make a lot of it very quickly," Shuren said.
- The CDRH chief made the case that the U.S. must "de-risk the enterprise" for test makers. "We did this for vaccines. We pumped all this money in to take the risk off of production," Shuren said, noting that didn't happen with diagnostics so that manufacturers were "skittish" and some had to be convinced to make tests. Shuren called for guaranteed minimum purchasing agreements and guaranteed reimbursement for companies that get FDA authorization.
Since the beginning of the pandemic, CDRH has prioritized at-home, over-the-counter diagnostics, which FDA contends has resulted in hundreds of millions of additional OTC tests available monthly to consumers. However, the U.S. approach to coronavirus testing has been tactical, rather than strategic, in response to surges in cases such as the omicron variant.
President Joe Biden in January, at the height of the omicron surge, announced that the federal government would purchase an additional 500 million rapid COVID-19 tests to distribute free to Americans to help meet the overwhelming demand for testing, bringing the White House's total purchase to 1 billion test kits.
As part of the initiative, the Biden administration has awarded contracts to test manufacturers including Abbott Laboratories, iHealth Labs, Roche and Siemens Healthineers. Abbott last week secured a $1 billion contract from the U.S. Army to provide rapid COVID-19 antigen tests to the federal government.
While Biden has acknowledged that his administration needed "to do better" with home testing, some members of Congress contend the federal government was caught flat-footed when the highly transmissible omicron variant spread quickly, straining U.S. test capacity.
Shuren during Wednesday's hearing pointed to South Korea as a success story in its response to the coronavirus pandemic and an example of effective policy. The CDRH chief said that country guaranteed minimum purchasing agreements and guaranteed reimbursement for test companies to help eliminate the risk, and advocated that the U.S. do the same going forward long before demand exceeds supply.
"If there isn't that demand or guarantee with contracts, companies will cut production. We saw it happen in the U.S.," Shuren testified, noting that "a company closed a manufacturing facility."
In response to the decline in coronavirus test demand, Abbott last year closed its Gurnee, Illinois, facility, axing about 2,000 jobs.
Shuren emphasized the strategy going forward is not about having a lot of different tests but having a lot of tests, arguing the U.S. must invest in high-capacity test manufacturers capable of producing large volumes quickly.
"To date, we've issued about a little over 450 authorizations for tests and self-collection kits and we should never be in that position again. If you want to solve it, pre-position manufacturers of tests in advance of the public health emergency," Shuren told lawmakers. "If there's funding to go do that, the country could be able to make these decisions also a lot faster with a few developers, large numbers and quick decisions."
AdvaMed has called for a renewed effort to sustain and strengthen COVID-19 test manufacturing after the White House warned it only has funding to maintain U.S. testing capacity through June.
The medtech lobby wants to see the Biden administration adopt warm-base manufacturing agreements "to contract with diagnostic manufacturers that have invested in expanded capacity during the COVID-19 pandemic to sustain these increased manufacturing levels."
AdvaMed has specifically called on the administration to issue requests for 12 to 24 month warm-base manufacturing agreements, which it contends will enable companies to ramp up capacity to meet demand in 60 to 90 days and have sufficient testing capacity in place quicker than was possible earlier in the pandemic.