Democrats have ramped up pressure on the Biden administration to invest more in at-home COVID-19 testing to address supply shortages, arguing that people are missing a key public health tool as a threatening variant emerges.
“Now that we have omicron, people are getting scared, and we know vaccines take a while to kick in and people want to see their families for the holidays. Everybody wants to test and be responsible, and now you can’t find tests again,” said Rep. Kim Schrier, a Washington Democrat.
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Antigen tests, unlike PCR tests that take at least a day to return results, allow people to test themselves for COVID-19 at home without a prescription. Ideally, the home tests could be used semiregularly and before traveling to mitigate the risk of unknowingly spreading the disease. But the high price, which ranges from $20 to $40 for a pack of two tests, and low stock nationwide have kept them out of reach for many people.
President Joe Biden announced a plan earlier this month to allow insured people in the United States to get reimbursed for their tests as long as they submit receipts to their insurer, a process that Schrier called too onerous for many people to use. Other countries such as Germany, the United Kingdom, and Singapore, meanwhile, have made these tests cheap and ubiquitous by placing bulk orders with test manufacturers and distributing them to the public at little to no cost.
“If you want to really smartly use taxpayer dollars, then you use them on a rapid at-home test because you get the results right away and you can make decisions that day based on it,” Schrier said. “If we really want to get hold of this virus and live a sustained normal life, then we need to have rapid tests available.”
Democrats have argued for an approach to scaling up testing similar to that of former President Donald Trump for vaccines — order in bulk from test manufacturers and pass down subsidized prices to the public.
The pandemic disrupted global supply chains, which affected products used in the test kits such as swabs and pipettes. Before the highly contagious delta variant overtook as the strain dominating global circulation in the spring, the manufacturing of tests had slowed. The pandemic was predicted to be on its way out, and demand for tests fell with the availability of vaccines in early 2021.
Congress allocated $50 billion with the spring passage of the American Rescue Plan Act to spend on expanding lab-based COVID-19 testing and bumping up the manufacturing and distribution of home test kits. The Biden administration also announced in October that it would purchase $1 billion worth of rapid at-home test kits, an investment it said would increase the number of at-home tests to 200 million per month by December.
“Until I go by the cash register and see [home test kits] right next to the chewing gum at the checkout line for a price of a couple bucks or less … when things have succeeded to that level, then I will feel like the job is finished,” said Rep. Bill Foster, an Illinois Democrat.
At the onset of the pandemic, the Trump administration put massive orders in for the various vaccines in production well before they were found to be effective to guarantee supply down the line, a move that took the financial risk of developing shots away from the pharmaceutical companies. The administration did not do the same for tests in production, which would have given test makers more incentive to pour resources into manufacturing a range of COVID-19 tests for home and lab use.
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“Government has to show some wisdom in making what are essentially speculative investments in a wide set of products with the understanding that not all of them will be helpful,” Foster said. “As a general approach I’m in favor of it, and I think that the rapid at-home testing is a perfect example of a product where federal money should be directed.”
Foster added that he is “not entirely pleased with the speed at which the [Food and Drug Administration] has granted approval.”
The FDA, which reviews clinical data for all tests in production before they can come to market, has fought back criticism that the regulatory process is too burdensome and opaque for manufacturers when compared with the processes used in Europe. The agency reviews home tests in the same way it reviews other medical devices, creating a laborious process that critics argue could be simplified in order to speed up delivery to stores.
The U.S. conducts exhaustive trials to ensure the home tests are reliable as well as easy to use, but the agency maintains that the process is not difficult to navigate as long as the science backing up the product is sound. To accelerate the review process, the Biden administration established the Independent Test Assessment Program within the National Institutes of Health in October, which combines the powers of all federal health agencies to assess over-the-counter tests and work with companies to compile the data needed for test authorization.
The FDA has authorized 16 home tests and will continue to evaluate new tests with priority for those companies that have mass production capacity.