James Boiani Quoted in “Virus Testing Push Leaves FDA Lab Oversight in ‘a Bizarre Limbo’”

Bloomberg Health Law & Business News

James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Health Law & Business News, in “Virus Testing Push Leaves FDA Lab Oversight in ‘a Bizarre Limbo,’” Jeannie Baumann.

Following is an excerpt:

More tests to screen for a variety of ailments will hit the market without FDA oversight under an HHS policy meant to make more Covid-19 tests available, muddying the debate over the agency’s role.

While the Food and Drug Administration oversees tests developed by commercial companies like Quest Diagnostics, it has more sparingly applied its authority over individual tests developed by labs at health-care centers and universities. The FDA had required an emergency use authorization for these lab-developed tests (LDTs) for Covid-19, but last week the Department of Health and Human Services did away with even that cursory oversight to cut red tape. However, that order goes beyond just coronavirus tests, waiving FDA oversight over all tests from laboratories.

The move leaves those laboratory tests in regulatory limbo, and reignites a long simmering debate over whether commercial tests and laboratory tests should be regulated differently. It’s a pressing question as a new generation of complex diagnostics can screen millions of DNA changes in a single test. …

The latest FDA policy—which came from the HHS and not the agency itself—said the FDA won’t require review of lab developed tests before they come to market unless there’s a formal rulemaking process. Developers of those tests can voluntarily undergo FDA review, which will give them liability protection under the Public Readiness and Emergency Preparedness Act.

The FDA had proposed regulating laboratory tests in 2014 to ensure their accuracy, but dropped that effort in favor of legislation. Laboratories had argued they were already regulated under the Centers for Medicare & Medicaid Services’ Clinical Laboratory Improvement Amendments. The debate appeared to be on its way to a legislative resolution before the pandemic hit.

‘A Bizarre Limbo’ …

James A. Boiani, an Epstein Becker Green attorney whose [areas] include in vitro diagnostics, said it was surprising the policy change came through the HHS, but it wasn’t necessarily a revolutionary change. FDA review of tests coming out of labs has been the exception.

“In the coming months, as the pandemic shows little sign of slowing, we’ll see more pushes to modify policies, at least at the edges, to move products through FDA more quickly. I think by and large FDA has been doing a very good job playing clean-up on a series of public health dilemmas they didn’t create. But there is room for improvement still,” Boiani said.