Federal Rules Holding Up Lab-Developed COVID-19 Tests

How streamlined regulations could help America react to COVID-19

By Ross Marchand. He is the director of policy for the Taxpayers Protection Alliance. 

"With inconsistent rules getting in the way of COVID testing, America’s dysfunctional regulatory system has made it more difficult for America to cope with the Coronavirus.

While laboratories face the nearly impossible task of complying with two different sets of regulations, shady companies with little real expertise are selling kits that don’t actually test for the Coronavirus.

Fortunately, legislation introduced by Sen. Rand Paul (R-Ky.) would unshackle laboratories and provide clear rules to give Americans access to reliable testing products. Americans deserve to know whether they have Coronavirus in a safe and timely manner. The current two-step bureaucratic process to develop a test is unnecessary and people are still struggling to get tested.

In plenty of places across America, it feels like self-isolation and stay-at-home orders will never end. Daily new cases number in the tens of thousands and hospitals continue to try and cope with the patients but more than a month after Americans were told by the authorities to shelter-in-place, less than 3 percent of the U.S. population has been tested for the virus.

The problem is that demand for testing far outstrips supply. As Modern Healthcare contributors Kelsy Ketchum and Leo O’Connor note, “the U.S. testing pipeline faced early problems. While the situation is improving, the country still has not caught up.”

As infection numbers spiked in late February, the Association of Public Health Laboratories had to beg the Food and Drug Administration (FDA) for permission to develop tests that could accurately detect COVID-19 in patients. The FDA eventually agreed, offering laboratories “emergency use authorizations (EUAs)” to develop their own tests but these research facilities are still facing an uphill regulatory battle and must deal with the Centers for Medicare & Medicaid Services (CMS) in addition to FDA bureaucrats.

Traditionally, CMS has taken the lead in inspecting laboratories and verifying laboratory-developed tests. This governmental body under normal conditions limits scientists’ ability to view lab specimens (and make diagnoses) remotely and requires separate regulatory certificates for different laboratories operating at the same facility. CMS finally relaxed these onerous restrictions at the end of March, while still requiring and monitoring labs’ proficiency tests to make sure that the lab is correctly evaluating their results. But in addition to continued (albeit flexible) regulatory oversight by the CMS, laboratories must also answer to FDA bureaucrats.

While these research professionals languish under excessive bureaucracy, snake oil salesmen are pedaling “scientific” products that don’t actually test for Coronavirus.

FierceBiotech reporter Conor Hale reports that, “Since mid-March, the FDA has let manufacturers distribute unauthorized antibody tests, provided they validate the tests themselves and do not advertise them as a standalone method of diagnosing a patient.”

By early May, nearly 200 antibody diagnostic products were circulating around the country while many of the testing kits remained unproven. After the National Institutes of Health found, through independent evaluation, that some of these tests are performing poorly, the FDA decided to tighten the screws again and require agency approval based on test effectiveness data.

Even with new, stricter enforcement, tests developed by a laboratory face higher regulatory hurdles than antibody tests being rolled out by private companies. Handicapping laboratories with two different regulators—the CMS and FDA—effectively keeps the most promising products developed by the brightest minds off the market.

Fortunately, the Verified Innovative Testing in American Laboratories (VITAL) Act (S. 3512) would ensure that the FDA has no regulatory authority over laboratory-developed tests. Under the proposed new regulatory structure, CMS oversight would be sufficient for developing tests.

Sen. Paul’s proposal would also require the CMS to update its rules and guidelines to keep regulations streamlined and reflective of current realities. The agency would become a one-stop-shop for approval, allowing laboratories to bypass the byzantine FDA.

Bureaucrats should be empowering scientists to help treat patients, instead of creating a regulatory obstacle course."