FDA plans to regulate lab tests

The Food and Drug Administration (FDA) notified top lawmakers Thursday of its plan to begin regulating laboratory tests used to diagnose dangerous diseases.

The announcement comes almost a month after Senate Democrats pushed the Office of Management and Budget to release FDA guidance that had been held up for years.

The agency attached the proposed guidance to their letters to Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce Committee, and Sen. Tom Harkin (D-Iowa), chairman of the Senate Health, Education, Labor and Pensions Committee.

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“The draft Framework Guidance proposes a risk-based, phased-in framework for oversight of [Laboratory Developed Tests] in a manner that is consistent with the FDA’s current regulation of in vitro diagnostic devices,” writes Sally Howard, an FDA deputy commissioner.

In the past, the FDA said it would not regulate diagnostic tests conducted at healthcare facilities because the tests were fairly simple and posed little risk to patients.

The agency’s position has changed over the past few years as the tests have become more complex and were used to diagnose more dangerous diseases such as cancer and Lyme disease.

“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” said Commissioner Margaret Hamburg.

“Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether,” she added.

Democratic lawmakers including Sen. Ed Markey (Mass.) and Rep. Louise Slaughter (N.Y) jumped at the announcement, saying it would advance personalized medicine and transform the healthcare landscape.

“Once this guidance is finalized, doctors and patients can rest and test assured knowing that certain high-risk diagnostic tests have been subject to the additional oversight by the FDA that will help ensure that diagnoses based on these tests are sound,” Markey said.

But not everyone is happy with the FDA’s decision. Rep. Michael Burgess (R-Texas) says the FDA’s guidance will stifle innovation and require more taxpayer funding.

“FDA is the subject of much criticism from industry groups who are already under their jurisdiction,” he said. “As such, they are overburdened and take too long to approve products, which increases uncertainty for companies and negatively impacts innovation, as well as patient access to new treatments and devices.”

And a source familiar with the issue says it is likely to spiral into a major political fight as the midterm elections loom, and there are millions of dollar at play. Lobbyists on both sides are likely to push legislatures to look out for their interest. 

 

— Updated at 3:32 p.m.