Conley Q & A on LDTs and the FDA

FDA v LDTIn her recent post on the FDA’s draft guidance on its proposed oversight of Laboratory Developed Tests (LDTs), Jen Wagner mentioned my interview with Genome Web’s Turna Ray on January 15, 2015. Turna asked me to address some arguments made in a “white paper” written by former U.S. Solicitor General Paul Clement and Harvard law professor Laurence Tribe on behalf of their client, the American Clinical Laboratory Association. The main point that Clement and Tribe made was that the FDA lacks legal authority to oversee LDTs, at least in the way that it’s proposing to do so. As I told Turna, I don’t necessarily disagree with their position; in fact, I’m skeptical about the FDA’s authority to do this. Also, like Jen, I’m not persuaded the proposed FDA initiative is likely to work well from a practical perspective. Nonetheless, I agreed to play along in a devil’s advocate exercise, making the counterarguments I’d make if representing the FDA. Here’s a brief summary of my arguments:

  • This wasn’t actually one of my arguments, but—isn’t “white paper” a little pretentious? The term came out of British government practice, and originally referred to an authoritative statement of the government’s position on some important issue. This is an advocacy piece written by lawyers on behalf of a client. It’s a paper (if you print it out), and it’s white (unless you print it on colored paper), but hardly in a league with the British White Paper of 1922 expressing support for a Jewish homeland in Palestine.
  • Tribe and Clement argued that the sequence and content of several Congressional enactments, including the Clinical Laboratory Improvement Act of 1967 (CLIA), the Medical Device Amendments of 1976 (MDA), and the CLIA Amendment of 1988, add up to a statement that Congress did not believe that the FDA had jurisdiction over LDTs. Tribe and Clement put particular emphasis on the argument that MDA covers “devices” and “articles,” “words that don’t naturally apply to clinical laboratory testing services.”
  • I responded that you can’t wring that much Congressional intent out of CLIA and MDA. They were separate pieces of legislation that dealt with discrete problems: CLIA, with the workings of labs; and MDA, with medical devices. I don’t see the juxtaposition of the two laws as evidence of any considered Congressional understanding of LDTs. And by the way, why don’t words like device and article “naturally” apply to lab testing? Doesn’t that process use concrete articles and devices? The definition of devices in MDA is very broad.
  • Tribe and Clement argued that the use of LDTs is part of the practice of medicine, which has always been understood to be a matter of exclusive state regulation, beyond the purview of the FDA and other federal agencies. The latter point about state jurisdiction is non-controversial. But what does that prove about LDTs? The federal government can’t regulate a radiologist’s exercise of judgment—that’s the practice of medicine. But can’t it regulate x-ray and scanning machines as medical devices?
  • Tribe and Clement argued that the FDA’s position is undercut by the fact that, all of a sudden, it’s going to assert regulatory authority when “they haven’t exercised this authority for 40 years.” Doesn’t this suggest that the FDA really believed that it never had such authority? An admission by conduct, by analogy to the law of evidence. My response is that regulators and prosecutors do this sort of thing all the time: they ignore a problem for a long time and then (often under public pressure) decide that it’s gotten more serious and that they need to act. I used the example of broken windows policing. I said: “If you apply that kind of logic to the FDA, their position is that they’ve always had this authority to [regulate LDTs], but in terms of priorities for their limited resources, given the nature of the LDT market, they didn’t think it was a good use of those resources. Because LDTs have become a bigger business, they’re more important, FDA now thinks LDTs pose a higher level of risk and they’ve decided to change their view on that.”
  • Tribe and Clement also objected to the FDA’s use of the “guidance” process rather than formal rulemaking under the Administrative Procedure Act, which is supposed to be the basis for the modern regulatory state. I’m not sure there’s a good counter to that, except that federal agencies—including the FDA—frequently try to avoid formal rulemaking, with its built-in delays and opportunities for judicial review. But that doesn’t make it right, legally or politically. As I said, the best that the FDA can do here is something along the lines of, “We don’t have to go through the full APA rulemaking procedure because we’re not actually issuing a binding rule. All we’re saying is we always had this regulatory authority and we’re just being transparent about when and how we’re going to exercise it.”