Given the need to act quickly and efficiently to respond to the COVID-19 emergency, the FDA said it will implement coronavirus-related guidances without first seeking public comment. However, it will accept comments on the documents and make changes as needed. Rather than publishing a separate notice in the Federal Register for each guidance, the FDA said it plans to publish periodic notices announcing the guidances issued since the previous notice. Also, instead of opening a docket for comments for each guidance, the agency is opening a docket for each center’s COVID-19-related guidance. The following docket numbers will be used: Center for Drug Evaluation and Research, FDA-2020-D-1136; Center for Biologics Evaluation and Research, FDA-2020-D-1137; Center for Devices and Radiological Health, FDA-2020-D-1138; Office of the Commissioner, FDA-2020-D-1142; and Office of Regulatory Affairs, FDA-2020-D-1143. In addition, all the agency’s guidances concerning COVID-19 will be available here.
In another break from normal, the FDA announced Sunday that, for the duration of the COVID-19 emergency, it doesn’t intend to take action against sponsors and others that don’t adhere to drug risk evaluation and mitigation strategies (REMS) that require patients to be monitored via certain laboratory testing or imaging studies. “The FDA recognizes … the completion of some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine,” said FDA Principal Deputy Commissioner Amy Abernethy. “Under these circumstances, undergoing testing or imaging studies in order to obtain a drug that is subject to a REMS can put patients and others at risk for transmission of the coronavirus.” The FDA is urging providers prescribing the drugs to consider whether there are compelling reasons not to complete the tests or studies at this time and use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of the testing. They also should communicate with their patients about the benefits and risks, the FDA said.
Citing safety concerns, workload and potential shortages, U.S. hospitals participating in the 340B Prescription Drug Discount Program are asking the Health Resources and Services Administration (HRSA), which administers the program, to postpone all audits during the coronavirus emergency, grant them more flexibility in registering for the program and reduce burdensome documentation requirements. 340B Health, which represents more than 1,400 hospitals participating in the program, sent a letter last week to HRSA, asking that the agency eliminate the documentation that’s required when they purchase private label drugs or drugs from group purchasing organizations (GPOs) due to shortages and the increased need for drugs to treat high volumes of patients. “Hospitals do not have the staff or labor hours available to chronicle the search for 340B pricing and [wholesale acquisition cost] pricing when drugs are in short or no supply during this public health emergency,” the trade group said. The letter noted that hospitals are reporting that, because of the global outbreak, they are unable to purchase many intravenous antibiotics except through a GPO. Under the 340B program, which was expanded in 2010 as part of the Affordable Care Act, qualifying hospitals and clinics purchase outpatient drugs at an average 50% discount and then can charge full price for the drugs. While community clinics are required to reinvest their 340B revenue into care for uninsured or vulnerable patients, hospitals have no restrictions on how they use the money. But they are subject to HRSA audits and some reporting requirements.
In a review of federal efforts to help prevent sexual harassment at universities that receive federal grants for STEM research, the Government Accountability Office (GAO) found that none of the federal agencies, including the NIH, has established goals and plans for their efforts to enforce Title IX prohibitions against such harassment. “Thus, they lack clear ways to evaluate how well these efforts are working and to identify any needed improvements,” the GAO said. “They may also be missing opportunities to coordinate and integrate prevention activities.” The review found that, from fiscal 2015 through fiscal 2019, the NIH received only one Title IX complaint. However, in fiscal 2019 alone, the NIH received 93 reports of sexual discrimination and harassment outside the Title IX complaint process. To better address the problems, the GAO made several recommendations to the Department of Health and Human Services (HHS), including that it establish goals and an overall plan to assess all of the NIH's sexual harassment prevention efforts for university grantees and that it direct the NIH and HHS Office for Civil Rights to develop and implement formal procedures for sharing information about Title IX and sex discrimination concerns.
The U.S. Court of Appeals for the Federal Circuit refused Monday to rehear a decision in Arthrex Inc. v. Smith & Nephew Inc., in which the appellate court determined that the way Patent Trial and Appeal Board (PTAB) judges were appointed was unconstitutional. While the March 23 denial of an en banc was brief, some of the judges wrote concurring and dissenting opinions explaining their views. A “rehearing would only create unnecessary uncertainty and disruption,” Judge Kimberly Moore wrote in a concurrence that was joined by three other judges. The solution the U.S. Patent and Trademark Office has followed – doing away with a protection in the America Invents Act (AIA) so PTAB judges can now be dismissed “at will” – was the “‘narrowest possible modification to the scheme Congress created’ and the approach that minimized the disruption to the continuing operation of the inter partes review [IPR] system,” Moore said. Judge Timothy Dyk disagreed in a dissent, which also was joined by three other judges. Eliminating the administrative patent judges’ protections from being fired rewrites the AIA “contrary to Congressional intent,” Dyk said. By severing that protection, the court performed “major surgery to the statute that Congress could not possibly have foreseen or intended,” he added. Dyk recommended that the Federal Circuit grant a temporary stay in the case while giving Congress a chance to legislatively fix the problem it created. In the alternative, he said, the USPTO “could fix the problem by creating an agency review process” consisting of a special panel, designated by the director and not subject to removal protections, to rehear decisions rendered by administrative patent judges. Insisting that Congress fix the problem “would require holding the inter partes review statute unconstitutional and paralyzing the [PTAB] until Congress acts,” Moore countered. To date, the Federal Circuit has vacated and remanded 37 IPR appeals that properly raised the PTAB Appointments Clause challenge before or in their opening brief. Appeals raising that challenge have been filed on another 44 PTAB decisions issued before the court’s October 2019 decision in Arthrex, according to Moore.