By Kevin Stawicki

Law360 (December 1, 2020, 10:35 PM EST) -- The U.S. Government Accountability Office has called for "urgent action" to improve the federal response to the coronavirus pandemic, accusing federal agencies of haphazardly changing public health guidelines, providing an inadequate vaccine distribution plan and failing to address testing supply shortages.

In a nearly 400-page review of the government's COVID-19 response, the watchdog on Monday zeroed in on the U.S. Department of Health and Human Services and the Centers For Disease Control and Prevention, listing a series of recommendations following up on previous reports from September and October that raised similar issues.

One of the watchdog's top concerns Monday was whether the CDC's decisions to change guidance related to virus testing and screening were based on science. Testing guidance updates have "not always been transparent," the report said, which runs the risk of "eroding trust in government."

There were internal inconsistencies within the CDC's guidance for testing implementation and prioritization in K-12 schools and long-term care facilities that the agency has changed without sufficient explanation, the GAO said.

"GAO recommends that HHS ensure that CDC clearly discloses the scientific rationale for any change to testing guidelines at the time the change is made," the agency said in the report.

The watchdog also reiterated recommendations from previous reports seeking to address nationwide shortages of medical supplies, including personal protective equipment and testing supplies. Nearly half of all states have recently reported shortages of reagents and rapid point-of-care tests, while 16 states have reported testing instrument shortages as of October, the report said, urging the federal agencies to meet those needs, especially amid a recent surge in COVID-19 cases.

The report called on the Centers for Medicare & Medicaid Services to clarify whether it is fully addressing nursing homes' concerns about testing, personal protective equipment and visitation after the agency failed to provide a clear picture of whether it has completed the tasks recommended by the CMS' Coronavirus Commission on Safety and Quality in Nursing Homes.

There are also holes in the Trump administration's blueprint to distribute about 40 million doses of COVID-19 vaccines by the end of December, according to the report. HHS, along with the CDC and the U.S. Department of Defense, rolled out a plan in September to distribute vaccines within hours of obtaining emergency use authorization from the FDA.

But the states and local governments have said they need more information about the criteria for vaccine distribution and what the states' role will be in that process, the GAO said, urging the federal government to respond to those requests.

The GAO called on HHS and the DOD to specifically "establish a time frame for documenting and sharing a national plan for distributing and administering a COVID-19 vaccine," adding that those efforts should be "coordinated across federal agencies and nonfederal entities."

General Gustave Perna, the chief operating officer of the Trump administration's vaccine program Operation Warp Speed, has maintained that the federal government has been in constant contact with governors and state public health officials about the details of the distribution plans, even running distribution rehearsals.

The watchdog further implored the U.S. Food and Drug Administration to be more transparent about its scientific and safety reviews for therapeutics and vaccines, as the regulator is set to consider requests for emergency use authorization for vaccines within the next few weeks.

"To improve the transparency of, and ensure public trust in, its EUA decisions, we recommended that FDA identify ways to uniformly disclose information from its scientific review of safety and effectiveness data to the public when issuing EUAs for therapeutics and vaccines, and, if necessary, seek authority to do so," the GAO said.

The FDA will meet on Dec. 10 to discuss granting emergency use authorization sought by Pfizer and its German partner BioNTech for approval of their COVID-19 vaccine. On Monday, the regulator said it will meet on Dec. 17 to consider Moderna's request for approval of its vaccine candidate.

Rep. James E. Clyburn, D-S.C., Chairman of the Select Subcommittee on the Coronavirus Crisis, called Monday's report "troubling."

"More than 10 months into this pandemic, the Trump Administration still refuses to learn from its repeated failures, leading to more disease, more deaths, and more economic devastation across this country," Clyburn said in a statement. "I strongly agree with GAO that we need 'urgent actions' to prevent the further loss of Americans' lives and livelihoods."

Prior to the publication of the GAO's report, the agencies addressed some of the watchdog's concerns in a Nov. 4 letter included in Monday's report. 

HHS said it developed "the most comprehensive supply management effort taken by our nation since World War II," adding that the government has addressed gaps in medical supplies. The agency also said the GAO showed no "acute shortages" of medical or testing supplies and offered little more than vague recommendations.

"Without access to GAO's 50 state survey and other information GAO relied on, GAO's findings are of negligible value to HHS and other executive branch agencies," HHS said in the Nov. 4 letter, slamming the watchdog for refusing to let it see its data. 

The FDA agreed to be upfront about its review of the vaccine candidates being considered for emergency approval. 

As for discrepancies in testing guidance, the CDC said in the Nov. 4 letter that it has consistently worked with experts and state and local officials to determine recommendations. 

CMS added that it has implemented "virtually all" of the recommendations by the Coronavirus Commission on Safety and Quality in Nursing Homes to address testing and visitation at nursing homes. 

--Additional reporting by Dorothy Atkins. Editing by Steven Edelstone.

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