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Gail Javitt Quoted in “New Genetic Test Guidelines Could Mean More FDA Approvals”

Bloomberg BNA Medical Devices & Industry Report

Gail H. Javitt, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in the Bloomberg BNA Medical Devices & Industry Report, in “New Genetic Test Guidelines Could Mean More FDA Approvals,” by Greg Langlois. (Read the full version – subscription required.)

Following is an excerpt:

New, final guidance for developers of next-generation sequencing tests—advanced diagnostic tests that could revolutionize health care—could be seen as additional FDA encouragement for them to obtain formal agency approval.

The FDA issued two long-awaited final guidance documents addressing its plans for development of NGS tests, which provide rapid analysis of a person’s DNA to identify mutations that cause genetic diseases or increased risk of diseases, or show how a person will respond to drug therapies. Although these tests are a promising tool for identifying and treating various types of cancer, cystic fibrosis, and other diseases, their rapid development has created regulatory uncertainty that the FDA’s guidance is aimed at addressing.

“I do think the agency is trying to get a handle on NGS, and NGS is moving pretty quickly into clinical use, and so I think their thoughts are helpful in articulating what they think are the key issues around NGS quality,” Epstein Becker & Green health care and life sciences member Gail Javitt told Bloomberg Law in an interview. …

“I do get the sense the FDA is trying to signal interest in working with entities that want to come through and get their tests on the market in an environment where, if you’re a clinical laboratory, you are not currently obligated to do that,” Javitt said.

All clinical laboratories must be CLIA-certified to receive Medicare or Medicaid payments. In March, the CMS announced Medicare would cover tests using NGS technology only if they are FDA-approved companion diagnostics. …

But Javitt noted the incongruence between what the FDA actually requires of test developers in the new development guidance and what they need to do to qualify for Medicare coverage.

The guidance addresses circumstances where test developers might not even require what’s known as 510(k) clearance, Javitt said. Under the 510(k) standard, the FDA simply “clears” a device shown to be “substantially equivalent” to one already previously cleared or formally approved. And not all changes to a device require 510(k) clearance.

“They’re looking to focus on what they think are the essential issues in ensuring accuracy and reliability of tests and are open to the concept that either in the first instance or down the road, companies might not have to keep coming in,” Javitt said.

The FDA is indicating premarket approval—a higher standard than 510(k) clearance—may not always be required, she noted, but the recent Medicare coverage determination does require formal approval for a test to be reimbursed.

“So I don’t know how you square that circle,” she said. “The regulatory pathway the FDA has in mind doesn’t necessarily match what CMS has proposed from a payment perspective.”