James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in STAT News, in “Congress Has a Chance to Close the FDA’s Theranos Loophole,” by Rachel Cohrs and Sarah Owermohle. (Read the full version – subscription required.)

Following is an excerpt:

Key decisionmakers in Congress are closer than they’ve been in years to revamping the way the government regulates some of the diagnostic tests that patients use to make crucial decisions about their health care.

Right now, tests developed in clinical labs, like those at academic medical centers and hospitals, don’t undergo the same scrutiny as tests developed by big, commercial test companies. The distinction was created in 1976, when tests created in labs were far less complex and had lower stakes for patients than today’s technology.

“Ultimately, the big question is: You have two groups that are designing tests. Do you want them to be held to the same standards?” said James Boiani, an attorney at Epstein Becker Green who advises device companies, diagnostics companies, and trade associations about regulatory issues. …

The bill that lawmakers are negotiating over now, called the VALID Act, would create a new category of Food and Drug Administration oversight for tests that could have serious  consequences for patients, no matter where they were developed. …

If the VALID act passes, the FDA wouldn’t regulate every single clinical test, but only tests considered “high risk” to patients, where the risk to patients of an inaccurate result could cause serious or irreversible harm.

One example would be a test for breast cancer that could lead a patient to have a mastectomy, Boiani said. …

The FDA does have authority to issue rulemaking to regulate tests, but it would likely be slowed down by litigation, Boiani said. Former FDA Commissioners Scott Gottlieb and Mark McClellan wrote in a recent op-ed that a regulatory-only approach would be “ill-fitted” and “far less efficient” than creating a new law, a sentiment echoed by two industry lobbyists who said FDA regulation alone could actually be less flexible for academic labs looking for exceptions.

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