The U.S. FDA’s routine guidance agenda may be badly disrupted by the COVID-19 outbreak, but the agency continues to pump out guidances and emergency use authorizations (EUAs) directed to the pandemic. While the FDA has included only one serological test under the diagnostic EUA paradigm, Rep. Diana DeGette penned a letter inquiring into when the agency intends to move more decisively on serological tests, arguing that the absence of action on this front endangers the nation’s economic health as well as the public’s health.

In an April 11 emergency use authorization for personal protective equipment, the FDA said several versions of the Sterrad sterilization system by Advanced Sterilization Products Inc., of Irvine, Calif., can be used to decontaminate N95 and N95-compatible respirator masks. This authorization is for single-user reuse only and is contingent on a state of shortage, and the FDA said the authorization is limited to two cycles per mask. The systems covered by this authorization include the Sterrad 100S, NX and 100NX sterilizers, which will use vaporized hydrogen peroxide.

Another development on the FDA front is the FAQ for the use of home blood glucose monitors in a clinical setting while the U.S. state of emergency declaration is in force. The agency said the use of home monitors can reduce interactions between patients and health care providers, which in turn may help suppress exhaustion of personal protective equipment (PPE) inventories. The FDA recommended that hospitals allow such usage, particularly given that some of these systems have wireless capabilities and thus can provide remote monitoring of the patient.

Rep. DeGette’s April 10 letter to FDA commissioner Stephen Hahn said there is a need to “massively invest in large-scale production and rapid deployment of” serology tests for the SARS-CoV-2 virus. DeGette cited a need to transition back to more normative economic activity, and urged Hahn and others in the Trump administration to prod the President to use the Defense Production Act to increase the production of FDA-approved serology tests, including any associated equipment and supplies.

DeGette noted that serology tests will be critical in determining who has acquired immunity to COVID-19 and thus can return to normal life, requesting also that the FDA develop “a national testing strategy” that addresses both molecular and serological testing.

House prods FTC on Covidien’s 2012 acquisition of Newport

Another issue for some members of the House of Representatives was the acquisition of Newport Medical Instruments in 2012 by Dublin-based Covidien. The deal was closed in March 2012, when Covidien paid $108 million for the Costa Mesa, Fla.-based Newport, which makes ventilators. The letter, signed by six Democrats on the House Judiciary Committee, posed the question of whether this was “indeed a ‘killer’ acquisition that is partly to blame for the current scarcity of ventilators.”

The authors of the letter stated that Newport was involved in a contract for ventilators, a development purportedly scotched by Covidien due to insufficient profitability. The signers requested copies of all FTC documents pertaining to the acquisition, which they asserted threatened “the prices of its own ventilators.” Covidien, which is part of the Medtronic portfolio of companies, also owns Puritan Bennett, another company in the ventilator business.

CMS, HHS add to volume of federal policy updates

The FDA is not the only federal government agency with a large volume of tasks to complete in connection with the COVID-19 outbreak. The Centers for Medicare & Medicaid Services (CMS) has a range of interests, including telemedicine and telehealth, and posted an April 11 FAQ for the agency’s coverage and reimbursement policies during the pandemic. The agency said recent legislation requires that payers cover the cost of in vitro diagnostics for the SARS-CoV-2 virus, assuming that either the FDA has approved or cleared the test, or that the test is included in an EUA. This includes serological tests, although the CMS noted that the FDA still harbors misgivings about the prospect of false negatives.

The Department of Health and Human Services likewise responded, providing guidance for investigators and institutional review boards involved in clinical trials during the pandemic. Given that some clinical settings already require COVID-19 screening, clinical researchers may be required to report such results, but the Office of Human Research Protections (OHRP) realizes that clinical investigators may have to deviate from study protocols.

The guidance says that there is no need for IRB review of any activities undertaken by clinical trialists that are driven by public health concerns or clinical health considerations that are outside the terms of a study protocol. This includes COVID-19 screening, which can be added to an existing, IRB-approved protocol without the IRB’s review.

Conversely, the trialist may be required to report a positive test result even if such disclosure is not encoded in the study protocol. The trialist may adjust a protocol to reduce the number of patient visits if needed to eliminate hazards to study subjects, and HHS said these policies comport with a recent FDA update on ongoing clinical trials.

Cuomo calls for staged reopening

New York Governor Andrew Cuomo said in an April 13 briefing that his state and several others in the U.S. Northeast are working on a plan to ease the restrictions that are hampering economic activity. The other states are New Jersey, Connecticut, Rhode Island, Pennsylvania and Delaware, and these states in the aggregate have reported more than 300,000 confirmed cases and more than 13,600 deaths.

Cuomo said he believes “we have reached a plateau in the number of cases” in New York, adding, “we should look forward to reopening … with a smart plan, because if you do it wrong, it can backfire.”

“The art form is going to be doing that smartly and productively,” Cuomo said, adding that this would be a cooperative effort with shared learning, data and resources. He said the novelty of the predicament should not necessarily erode public confidence in a gradual reopening of economic activity that has been shuttered by the pandemic. Each state will appoint both public health and economic development officials, and a working group will be formed from these officials and each of the governors’ chiefs of staff to craft a reopening plan. These officials will commence with development of such a plan “immediately,” Cuomo said.

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