The FDA precertification program for digital health has raised eyebrows across the industrial spectrum on several points, but the program has now caught the attention of three members of the U.S. Senate. An Oct. 10 letter from the trio, a document spanning a dozen pages, pokes at the agency on a number of issues, including the question of whether the agency has the statutory authority to conduct a premarket review process that bears no apparent resemblance to anything found in the Food, Drug and Cosmetic Act.
The FDA precert program was the target of criticism from early on regarding whether the organizational certification process was equivalent to a premarket review of each application, but the agency has a compelling argument that its traditional review mechanisms are too clunky for the fast-moving digital space. Nonetheless, Senators Patty Murray, Elizabeth Warren and Tina Smith posed the question of whether the FDA believes the law provides the agency with the authorities to conduct the precert pilot, let alone stand up a full-blown precert program.
The letter also raises the question of whether high-risk devices would be allowed to make use of the precert model, and whether the National Evaluation System for Health Technology will be serviceable as a medical device registry in time to sustain the precert program’s momentum.
On the compliance side, the senators state that there is no evidence the FDA has issued an inspectional form 483 to any companies regarding software products, but they also raise the prospect that the precert program’s mechanism for bypassing premarket reviews for individual products could diminish the volume of user fees collected over the course of the existing user fee agreement.
One of the interesting things to consider is the matter of the senators’ home states. Murray is from Washington, not exactly known as a hotbed of med-tech innovation, but Warren’s and Smith’s home states – Massachusetts and Minnesota, respectively – are indeed medical device hubs for traditional hardware medical devices. That does not necessarily mean that the old guard among device makers is pushing back against what they might see as either favoritism to digital or a high-risk enterprise by the FDA that could damage the reputations of all device makers, but that possibility cannot be ruled out, either.
The Unfinished Business of Myriad
The patent law case of AMP v. Myriad handily brought an end to patent subject matter eligibility for DNA, but the Supreme Court’s June 2013 decision in the case left a few moving parts in play for the life sciences. A case recently emerging from the Court of Appeals for the Federal Circuit suggests that while the outcome in Myriad left complementary DNA in a good place where Section 101 tests are concerned, the use of oligonucleotide primers may now be an appropriate topic for another look if the remarks by one of the judges at the Federal Circuit are any indication.
The Federal Circuit decreed in Roche v. Cepheid that the contested Roche patents, which Cepheid was alleged to have infringed, were not patent eligible, principally because of the test’s reliance on amplified DNA. However, the test also makes use of a number of oligonucleotide primers, which is where the three-judge panel was split.
Judge Kathleen O’Malley made the point that there was nothing in the Supreme Court record for Myriad that spoke directly to the question of subject matter eligibility for these primers, and she said there was some confusion at the Federal Circuit on that point as well. Strictly speaking, O’Malley’s opinion is a concurrence, but she clearly believes the Federal Circuit botched a chance to clarify an issue that is pertinent to a number of diagnostics that make use of primers during the amplification process.
O’Malley said the mere fact that the primers replicate the DNA in question does not necessarily mean the primers are entirely identical to the DNA of interest, but it is not clear yet how Roche intends to respond. The case drew the attention of several patent blogs, but by no means all of them, so this is as yet a niche legal issue. That could change quickly, however, if the question arises again, which seems nearly certain given the widespread use of polymerase chain reaction technologies for in vitro diagnostics.