The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation.
New York Governor Andrew Cuomo is among those who have called on the Trump administration to enact the DPA, but Cuomo also said, “where we are today, you will be in three weeks,” in a March 24 press briefing. Cuomo said those who have recovered from the virus are among those who might be allowed to return to work earlier than others, although he offered no timeline for such a gradual return to normal work activity.
Regarding return to work, Cuomo said, “I also don’t believe it’s either/or. I believe you can have a refined public health strategy. You can have people go to work,” including younger people. However, he said, “the President said it’s a war. Then act like it’s a war!” Businesses have indicated they need startup capital in order to convert their facilities to produce items such as ventilators, Cuomo said, adding “what am I going to do with 400 ventilators when I need 30,000?”
Schatz and Murphy said in a March 23 statement that the bill would both federalize the manufacture and distribution of medical supplies, but would also reduce the inefficiency incurred with 50 states and numerous hospitals competing for those supplies. The situation is “both unnecessary and barbaric,” they said, adding that the bill would require the production of 500 million N95 respirator masks, 200,000 ventilators, and 20 million face shields.
Peter Gaynor, director of the Federal Emergency Management Agency (FEMA), said FEMA will enact the DPA. “We’re actually going to use the DPA for the first time today,” for test kits, Gaynor said, adding that the agency wants to avoid a predicament in which N95 masks are allocated in a manner that leads to misuse. Gaynor said the agency will also seek to obtain roughly 60,000 test kits for SARS-CoV-2 diagnostics, which would invoke the allocation provisions of the DPA. “We want to be thoughtful and meaningful about how we do it for the best result,” he said.
Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said in a March 24 statement that industry is “mobilizing at never-before-seen levels” to address the need for equipment and supplies. Whitaker said many firms have added shifts and production lines to ramp up volume, adding that manufacturers of ventilators are turning out as many units as possible via production increases. Nonetheless, he said the most efficient way to ensure appropriate sourcing and allocation would be for the Trump administration “to designate a lead agency, such as FEMA, to oversee these decisions with the active input of clinical experts, the CDC and the medical technology industry.”
CDRH goes virtual, extends response deadlines
The FDA’s device center posted a March 23 letter to industry stating that upcoming meetings with device makers would be converted to teleconference meetings, with no change to the existing dates. The meetings that are currently affected by this policy are those scheduled through April 30, although the FDA will reconsider extending the affected period pending further developments.
Sponsor response deadlines for a variety of application types will be delayed for 60 days, a policy that applies to 510(k) filings, humanitarian device exemptions, de novo petitions and PMAs, including PMA supplements. Sponsors need not apply for the extension, and the agency said sponsors should submit reports for Section 522 and other post-market studies “when possible.”
The letter, signed by Bill Maisel, director of the Office of Product Evaluation and Quality at the Center for Devices and Radiological Health, also stated that CDRH is still processing incoming documents. However, CDRH is “unable to accept incoming submissions via email,” which is subject to file size limitations. CDRH is examining other electronic options, Maisel said, but he did not make direct reference to the e-submission mechanism.
The FDA had posted a final guidance for eCopy submissions for medical devices in December 2019, an overwrite of a similar document from four years earlier. The guidance allows sponsors to use CDs, DVDs and thumb drives to transmit documents related to a range of premarket submissions, including emergency use authorizations, but the guidance suggests that the aggregate file size of such filings not exceed one gigabyte. The March 23 FDA letter to sponsors does not specify a file size limitation for e-mailed submissions.
CDRH posted an update to its FAQ for diagnostic testing for SARS-CoV-2, noting that alternatives to conventional swab transport media are available. The agency said oropharyngeal specimens collected by health care professionals can be used in lieu of nasopharyngeal specimens, as can mid-turbinate specimen collections. Anterior nares specimens obtained via on-site, self-collection is also an option, although the agency said these latter two options are appropriate only for those who are asymptomatic.
There are as yet insufficient data to back the use of buccal swabs or saliva specimens used in solo, but the FDA said sputum samples would be an acceptable lower respiratory specimen.
Vice President Mike Pence said on a March 24 virtual town hall that the federal government had shipped 2,000 ventilators to New York and that another 2,000 would arrive by March 25. Deborah Birx, the coordinator for the administration’s coronavirus task force, said the U.S. has done more testing in the past eight days than South Korea did in eight weeks. “We did that because we transformed the testing process,” Birx said. The task force has scheduled a briefing for 5:30 p.m. U.S. Eastern time March 24.
Relief bill vote delayed
The Senate continued to debate the economic salvage bill March 24, but The Coronavirus Aid, Relief and Economic Security (CARES) Act was stalled after multiple attempts to close debate. The bill is not scheduled to come up for a vote on the Senate floor until the evening of March 24.
The CARES Act (H.R. 748) was blasted by the American Clinical Laboratory Association (ACLA), however, in a March 23 statement. ACLA President Julie Khani said ACLA member labs, “in a matter of weeks … went from a standing start to performing 50,000 COVID-19 tests a day.” Those labs had completed nearly a quarter of a million tests by that date, Khani said, adding that this represents a quadrupling of the daily test volume in the week prior to March 23.
The affected labs have not yet been paid for tests already performed, but Khani noted that some samples come in with little or no information regarding the appropriate payer, which puts the cost on the lab. Labs need additional equipment, supplies and protective gear, Khani said, adding that Congress should “recognize the critical role that labs have played on the front lines since day one.”