The U.S. FDA has updated its previous guidance for testing for the SARS-CoV-2 pathogen with a policy that gives the 50 American states and territories authority to oversee testing in those states. FDA commissioner Stephen Hahn said on a March 16 press briefing that the updated guidance is a significant step intended to offer additional flexibility to the states by labs in those states, adding that this was prompted by feedback suggesting a need for a more flexible regulatory approach. “From a practical point of view, the state department of health can act as a surrogate for FDA,” Hahn said, adding that this policy requires notification and transparency on documentation of validation. Hahn said that while the original policy of Feb. 29 was intended only for labs certified as high-complexity labs, the agency does not intend to object to commercial manufacturers who distribute supplies for tests developed by those manufacturers, although they will also be subject to the 15-day notification policy upon commencement of test utilization. He acknowledged there is pressure on the supply chain for reagents, swabs and other supplies, but vowed that the FDA would provide regular updates regarding alternative sources of supply should there be a shortage. The policy further points to the use of serological tests, which are more prone to false negative results, a predicament that both the FDA and the CDC were explicit in their efforts to avoid in the early stages of the testing roll-out.
The FDA has postponed the April 16 meeting of the circulatory systems advisory committee, which was scheduled to hear the application for the Transmedic Organ Care system by Transmedics Inc., of Andover, Mass. The agency did not give an alternate date for the hearing, stating only that all non-essential meeting through the month of April are either canceled or postponed.
A decision handed down Tuesday in the U.S. Court of Appeals for the Federal Circuit shows the Supreme Court’s broad interpretation of the §101 patent eligibility threshold that has made it increasingly difficult to protect patents involving natural phenomenon may not be a total killer of all patents related to diagnostic tests. In a 2-1 decision in Illumina Inc. v. Ariosa Diagnostics Inc., the Federal Circuit reversed a lower court that had invalidated two related patents – the ’751 and ’931 patents – which claim methods of preparing a fraction of cell-free DNA that is enriched in fetal DNA. Differentiating the challenged patents from Sequenom claims on a prenatal test that were tossed in 2015 because they merely cited a natural phenomenon, Judge Alan Lourie wrote for the majority, “This is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case.” Rather than simply observing that extracellular fetal DNA in maternal plasma is shorter than maternal DNA, the patents claim specific methods for exploiting the phenomenon by detailing process steps that change the composition of the mixture, resulting in a DNA fraction that is different from the naturally occurring fraction in the mother’s blood, Lourie said. Thus, the majority concluded that the claims meet the §101 threshold for patent eligibility. Judge Jimmie Reyna came to the opposite conclusion in his dissent, agreeing with Ariosa, which is part of Roche Holding AG, that the claims were directed to a natural phenomenon, not a patentable method. “The patents’ only claimed advance is the discovery of that natural phenomenon,” he said. The March 17, 2020, opinion might not be the final word on the patents, as Lourie left the door open for challenges on other grounds such as obviousness. “We make no comment on whether the claims at issue will pass muster under challenges based on any other portion of the patent statute,” he said.
The FDA this week issued draft guidance encouraging the use of restricted delivery systems to limit the unintentional ingestion of oral liquid drugs and biologics by children. The guidance urges manufacturers to use a restricted delivery system such as a flow restrictor as part of the packaging of their oral products as an additional measure to reduce the risk of unintended ingestion. The draft describes the elements that should be considered in developing such systems. Comments on the draft should be submitted to Docket No. FDA-2020-D-0567 by May 18, 2020.