Source : Medtech Insight
AdvaMed is asking the US Department of Health and Human Services (HHS) to renew the COVID-19-related Public Health Emergency (PHE) that has been in effect since January. The group also wants the medtech industry to be included in any future discussions about ending the PHE.
In a letter to health secretary Alex Azar, Scott Whitaker, CEO of AdvaMed, asked that the current PHE continue in order to tackle the coronavirus pandemic. He warned that if the PHE were to expire as planned on 25 July, products such as personal protective equipment and coronavirus tests that have been allowed on the market through Emergency Use Authorizations (EUA) would no longer be available until they’ve gone through the US Food and Drug Administration’s usual premarket application pathways.
Initially declared by Azar on 31 January, the PHE allows the government to take steps such as relaxing regulatory oversight to allow products intended to address the crisis to get to patients faster. The declaration was renewed on 21 April, but would expire this month if not renewed by the health secretary.
“By extending the PHE, you’re extending our ability to meet the demands of a pandemic-era health care system,” said Whitaker. “For example, if the PHE is extended, FDA can continue to authorize emergency use of COVID-19 diagnostics and treatments via expedited premarket review. Dozens, if not hundreds, of currently used COVID-19 diagnostics and treatments – including virtually every COVID-19 test and several ventilator varieties – have entered the market successfully through this system. Under the PHE, new innovation will continue to flourish – not to mention those existing diagnostics and treatments can remain on the market without long, costly regulatory reevaluations.”
Despite speculation and concern that the PHE may expire, Azar’s press secretary Michael Caputo indicated the secretary is set on renewing the PHE again in a 29 June tweet.
“Enough already. [HHS] expects to renew the Public Health Emergency due to COVID-19 before it expires,” he wrote. “We have already renewed this PHE once.”
Longtime friends, Whitaker and Azar met while serving in government together. Whitaker even coached Azar before his Senate nomination hearing. The medical device industry lobbyists has also said he’s in regular contact with the HHS secretary to ensure the medtech industry is able to voice their needs. MT121790
Despite their close relationship, Whitaker appears to have used the letter to officially ask Azar that the medtech community have a seat at the table when the secretary decides to end the PHE.
“We’d also recommend that industry stakeholders be given reasonable advance notice prior to any termination of the declared public health emergency, and an opportunity to comment on the impact of any discontinuations of COVID-19-related agency policies that went into effect during the declared public health emergency, as well as the time necessary for industry stakeholders to transition their operations to a post-public-health-emergency regulatory environment,” Whitaker added.
Besides expediting new products to market to help health care providers fight the ongoing pandemic, the PHE has also been helpful in getting telehealth services to patients, especially those in rural areas. It’s also allowed hospitals to increase their bed capacity and health care providers to work outside their licensed jurisdictions.
“We encourage you to retain some of these supports permanently, beyond the public health emergency,” Whitaker said.
The PHE, however, hasn’t gone off without a hitch.
In a recent report from the US Government Accountability Office (GAO), the agency highlighted shortcomings in government efforts to provide and collect data from viral testing nationwide. It also noted a shortage of supplies to tackle the pandemic, especially in the Strategic National Stockpile, which has been found not to have sufficient amounts of medical devices such as PPE and ventilators. Shortage of the latter prompted the president to invoke the Defense Production Act which directed manufacturers from the automotive industry to produce ventilators.
The report also highlighted issues with the FDA’s process to get COVID-19 tests to market. The GAO noted the first test for the virus authorized by the FDA in the US was a test developed by the Centers for Disease Control and Prevention (CDC) for public health laboratories, which immediately hit serious snags. ("Faulty CDC COVID19 Assays Leave Only 12 US Jurisdictions With Testing Ability CDC Director Says" "Medtech Insight" )
“[The CDC test] experienced accuracy and reliability issues that resulted in significant delays in testing nationwide during the critical early weeks of the outbreak,” said the GAO. “In response to concerns about the availability of COVID-19 tests, FDA made several policy changes.”
The initial criticism of the FDA’s regulatory oversight of such tests led the agency to significantly reduce regulatory constraints. The agency relaxed restrictions on the labs that could run COVID-19 tests, the test kits that could be used, and, more controversially, how antibody or serology tests could get to market.
The FDA initially put out a guidance that allowed antibody tests to be sold in the US if the manufacturer had simply validated the test. However, after a CDC study found a significant number of such tests had serious efficacy concerns, the FDA tightened its regulations, restrictingthe number of tests getting a EUA. ("FDA Yanks Potentially Faulty COVID-19 Antibody Tests And More May Be On The Chopping Block" "Medtech Insight" )
The FDA’s initial decision was met with strong criticism from various stakeholders, including some lawmakers. ("Experts At US House Subcommittee Criticize FDAs Initial Lack Of Serology Testing Oversight" "Medtech Insight" )
The GAO report also noted there’s been a shortage of key testing supplies, such as swabs and testing reagents, but said the FDA has stepped in to try to alleviate the problem through measures such as finding alternative testing components.
Overall, the GAO notes that as of 16 June, the FDA has issued 139 EUAs to test kit manufacturers and commercial and other laboratories. This included 119 EUAs for molecular and antigen diagnostic tests and 20 EUAs for antibody tests.
Despite the shortcomings of the government’s response through the PHE, Whitaker said the response has overall been a success.
“At the end of January, your office declared a public health emergency (PHE) to bolster our healthcare community’s COVID-19 relief efforts,” he said. “It worked: Since then, we’ve delivered 86 commercial in vitro diagnostic tests for COVID-19 and tested millions of Americans; we’ve increased personal protective equipment production capacity above 100 percent; and we’re delivering 10,000 ventilators per week to the hospitals that need them most. This historic ramp-up would not have been possible without the regulatory flexibilities and availability of resources facilitated by the PHE.”
By Ferdous Al-Faruque