James A. Boiani, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Law360, in “Life Sciences Regulation to Watch in 2018,” by John Kennedy. (Read the full version – subscription required).

Following is an excerpt:

The agency's Trump-appointed commissioner, Dr. Scott Gottlieb, has promised to work toward lower drug pricesby making the FDA's own review process more efficient — which would result in more generic options — and by taking action against anti-competitive activity in the drug market. In doing so, Gottlieb is showing he seems to understand the public health and economic benefits of getting more safe and effective treatments to the public, said James Boiani of Epstein Becker & Green PC.

"There are lots of ways you can prove whether something's safe and effective, and sometimes manufacturers are having to take the long road instead of the shorter road," Boiani said. "That's been a concern that I think he's been trying to address internally …”

Although some aspects of the Obama administration's 21st Century Cures Act — including a requirement that the government evaluate the possible use of real-world evidence in approving drugs — have begun to be implemented, there's still more to be done, experts say.

One area of interest for Boiani is the Clinical Laboratory Improvement Amendments program, which regulates medical tests developed by laboratories. The act calls for improvements in the process for tests seeking CLIA waivers, which aid in getting lab-developed tests into doctors' offices.

The FDA published draft guidance on the subject at the end of November, but Boiani said more discussion could be coming. The agency is supposed to finalize the guidance by the end of November 2018.

CLIA waivers may not be on everyone's radar, but they're shaping up to be an active subject area that could pick up speed, Boiani said.

For years, the FDA held that the accuracy of a test shouldn't be affected when it changes hands from experts to untrained providers; if a lab worker can use the test with 80 percent accuracy, a doctor should be able to do the same, Boiani said. In that environment, a number of tests, including the first HIV test, quickly received CLIA waivers.

Then, in the early 2000s, the FDA changed its mind, saying that instead of focusing on trained and untrained practitioners receiving the same results, nonexperts must be even more accurate. That causes problems when a test that's FDA-approved to be 85 percent accurate in the hands of experts is denied a CLIA waiver because the agency says it has to be 95 percent accurate when used by nonexperts, Boiani said.

The FDA's recent draft guidance appears to have reiterated that position, he explained.

"The legislative history is extremely clear on this point," Boiani said. "Congress wasn't telling them that these CLIA-waived tests need to be more accurate in the hands of physicians than they do in lab techs', they're just saying it needs to be equally accurate."

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