I finally had a chance to watch the complete Congressional hearing on LDT regulation that took place several weeks ago. Several interesting things came up which I haven't seen mentioned anywhere else:
- The issue of FDA's authority to regulate LDTs may not in fact be settled. Congressman Michael Burgess (R, Texas) stated that he firmly believes FDA does not in fact have the necessary statutory authority, not just to regulate LDTs without rulemaking, but even to regulate LDTs at all (under the opinion that they are a service not a product). Burgess is the co-author of a 2007 bill to modernize CLIA, and so may have a significant horse in the game.
- It still remains unclear how FDA's draft guidance made it out of the Office of Management and Budget. Congresswoman Anna Eshoo (D, California) pressed FDA's Jeffrey Shuren on this matter, and Shuren stated that "a higher authority weighed in." Burgess stated in his follow-up that he would "really, really like to know" who this person was, and wondered whether an economic impact analysis had ever been conducted in relation to FDA's proposed regulations. Shuren stated that he did not have "hard numbers."
- Evidence for proof of harm from faulty or improperly used LDTs was requested by multiple Representatives, including Burgess, Renee Ellmers (R, North Carolina), and Henry Waxman (D, California), and Shuren promised to provide details to all parties. When pressed on this issue by Waxman, Shuren trotted out the Ovasure story yet again. From what I can see this story is the only piece of evidence that FDA has ever presented on the issue of risk, and not only is it not as damning as FDA seems to believe, it is also getting more than a little stale - time for some quantitative data, FDA.
- FDA-approved tests are not always superior to LDTs, despite how hard it may be for FDA to believe. Alan Mertz, President of the Americal Clinical Laboratory Association, made an interesting point regarding test innovation that I have not heard previously made. He stated that with FDA tests, technology is "frozen in time," and that lengthy review periods make it impossible for FDA tests to stay current. He used the example of BRAF tests, where the FDA-approved tests do not cover all of the mutations that are currently relevant clinically, prompting the AMA to promote LDTs as superior and for doctors to request them more often. Shuren was incredulous on at least one occasion during his testimony when describing the existence of cases where LDTs were used when an FDA test was available. Mertz's point was an interesting and highly relevant assault on FDA's position that an FDA-approved test is by definition superior.
- Mertz also stated an estimate that 800-1,000 new LDTs come to market each year. This is the first such estimate that I have ever heard made in reference to the new LDT releases, and given Mertz's position is probably a good estimate. Those who believe that FDA hasn't got a chance of getting in front of LDTs due to sheer overload may well have a point.