The U.S. FDA said it will hold two workshops between the end of March and mid-April 2020, the first of which is a March 31 workshop on the use of patient preference information in medical device regulatory decisions. The sub-title of the workshop is “Benefit-risk and Beyond,” and will take place at the agency’s White Oak campus in Silver Spring, Md. The April 13-15 workshop on good simulation practices in health technologies will likewise take place at the White Oak campus, although the first day will be only a half-day session, taking place in the afternoon. The agency will webcast both workshops.
The U.S. Centers for Medicare and Medicaid Services acknowledged missing the self-imposed Feb. 14 deadline for the draft rewrite of the national coverage memo for transcatheter mitral valve repair devices. The agency accepted the request for a reconsideration and initiated the reconsideration Aug. 14, 2019, with the public comment period closing a month later. In a Feb. 18 note on its website, the CMS said it will not post a proposed rewrite of the mitral valve repair coverage policy, but that “a decision is forthcoming.”
The U.S. International Trade Commission determined that Bio-Rad Laboratories Inc., of Hercules, Calif., infringed on several claims found in three patents held by 10X Genomics Inc., of Pleasanton, Calif., although the commission found no infringement of a fourth patent. The ITC said it has issued an exclusion order prohibiting further importation of microfluidic systems along with a cease-and-desist order against Bio-Rad. A bond of 25% of entered value has also been imposed on Bio-Rad’s violative microfluidic devices.
With the help of the government of India, the FDA took a broad sword last month to illicit drugs and combination medical devices being shipped from India to U.S. consumers. Operation Broadsword, the FDA’s first bilateral enforcement operation with officials in India, stopped about 500 shipments of potentially dangerous, unapproved medical products, including opioids and drugs intended to treat serious diseases such as cancer and HIV, the agency reported Feb. 18, 2020. The operation targeted packages entering the U.S. through an international mail facility Jan. 28-30. Investigators from both governments examined more than 800 shipments, which identified about 50 different FDA-regulated products. Many of the shipments, including opioid drugs, had been transshipped through third-party countries to conceal their point of origin and avoid detection, the FDA said. “A bilateral enforcement exercise like Operation Broadsword allows us to closely work with our U.S. counterparts so as to share best practices, develop intelligence, better target suspect consignments, consignors and other bad actors at both ends,” said Balesh Kumar, director general at India’s Directorate of Revenue Intelligence. He noted the potential for long-term capacity building, pledging his agency’s commitment to fighting illicit drugs and narcotics through international cooperation. In fiscal 2019, the FDA screened about 25,200 parcels coming through international mail facilities. Of the more than 41,000 products contained in those parcels, the agency detained more than 38,000. More than 17,000 of the detained products are drugs that likely will be destroyed under the FDA’s administrative destruction authority, the agency said.
The coronavirus outbreak in China is taking a toll on the FDA’s enforcement efforts and resources. Due to the U.S. State Department travel advisory, the agency currently is not conducting drug, device or food inspections in China. In a normal year, the agency conducts about 500 inspections in China, according to FDA Commissioner Stephen Hahn. While he didn’t indicate how many inspections were scheduled for February 2020, Hahn said 90% of the ones planned for the month were routine surveillance inspections. The FDA was able to postpone the remaining for-cause inspections scheduled in February after reviewing all available information on a case-by-case basis. Hahn said the agency expects it also will have to postpone routine surveillance inspections slated for next month in China; the majority of those are for medical products. “We will continue to closely monitor the situation in China so that as the situation improves, we will be prepared to resume routine inspections as soon as feasible,” Hahn said. In addition, the agency is proactively identifying potential disruptions to supply or shortages of critical drugs and medical devices in the U.S. “We are not waiting for drug and device manufacturers to report shortages to us,” Hahn said. Instead, the FDA has contacted hundreds of manufacturers and is working with other international regulators to spot early warning signs of potential manufacturing discontinuances or interruptions due to the outbreak. While no FDA-licensed vaccines, gene therapies or blood derivatives are manufactured in China, much of the raw material is produced there and in other locations in Southeast Asia. The FDA is in contact with biologics manufacturers to gauge any supply concerns regarding the raw materials. “This remains an evolving and very dynamic situation with respect to potential shortages,” Hahn said. “We are tracking reports of increased ordering of some essential medical devices through distributors, such as personal protective equipment.” If the agency identifies a potential shortage or disruption of medical products, it will use all available tools to mitigate the impact to U.S. patients, Hahn added.
Sanofi SA and other makers of combination products regulated as drugs got some judicial direction last week on listing patents covering the device components in the FDA’s Orange Book when the U.S. Court of Appeals for the First Circuit revived a proposed class-action antitrust case against the Paris-based company. Filed by direct purchasers of Sanofi’s Lantus (insulin glargine) Solostar injector, the appeal posed two questions: did the drug company improperly submit a patent for listing in the FDA’s Orange Book and, if so, is it potentially liable under the antitrust laws to purchasers who were allegedly harmed by the effective extension of Sanofi's monopoly. “We answer ‘yes’ to both questions,” the First Circuit said in vacating a lower court’s dismissal of the case. The patent in question claims the drive mechanism used in an injector pen. The court agreed with Sanofi that patents for delivery devices that are part of a finished drug product are permissible in the Orange Book, but the court stipulated that such patents must claim the actual drug product. It noted that the ’864 patent is missing that vital link as it doesn’t claim or even mention the Lantus Solostar. Neither does it claim any injector pen or even a method of using a pen. “It therefore follows that because the claims of the '864 patent do not mention the drug for which the sNDA was submitted, the patent does not ‘claim the drug,’ and it was improper for Sanofi to have submitted it for listing in the Orange Book,” the court said. In justifying its listing of the patent, Sanofi pointed to communications the FDA has had with other manufacturers of combination products about what device patents could be listed. Sanofi said the agency hasn’t responded satisfactorily to any of the requests. “Instead, the FDA has simply acknowledged that the Orange Book ‘was not designed to separately address combination product listings or to identify the specific type of drug delivery system’ and that it ‘could benefit from enhanced listing capabilities,’" according to court documents. Responding to that argument, the First Circuit said, “We find no warrant to read anything into the FDA's nonanswer beyond a conclusion that it simply chose not to answer the question. To infer an answer, or even to infer that silence by the FDA indicates that the correct answer is uncertain, would be to force agencies to respond to all inquiries lest their silence be misunderstood.” It added that “the fact that the Orange Book is not designed to separately address combination product listings hardly helps Sanofi's argument that the '864 patent was listable as claiming a component of a combination product.” In sending the suit back to the lower court, the First Circuit said the defense to antitrust liability for improperly submitting a patent for the Orange Book is to prove that a submission resulted from “a reasonable, good-faith attempt to comply with the Hatch-Waxman scheme.”