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www.fdanews.com/articles/201106-gao-finds-pandemic-response-hampered-by-vaccine-distribution-issues

GAO Finds Pandemic Response Hampered by Vaccine Distribution Issues

January 29, 2021

The Government Accountability Office (GAO) has issued its fifth report on the federal government’s efforts to combat the COVID-19 pandemic, citing concerns that critical issues have still not been addressed, including the need for a “clear and comprehensive vaccine distribution plan.”

The latest report offers 13 new recommendations geared toward improving the U.S.’ response to the coronavirus, adding to a growing list of suggestions that the GAO said have still not been implemented.

As of the new year, 27 of its 31 previous recommendations had not been put into place, the government watchdog said, noting it “remains deeply troubled that agencies have not acted on recommendations to more fully address critical gaps in the medical supply chain.”

In September 2020, the GAO first suggested that HHS, in collaboration with the Department of Defense, should develop a timeframe for releasing a national vaccine distribution and administration plan.

In its latest report, the GAO calls on HHS to define the specific roles and responsibilities for each of the federal and nonfederal entities involved and include plans to communicate with the public to ensure vaccine confidence.

In other recommendations to bolster the FDA’s pandemic response, GAO said the FDA commissioner should scrutinize the impact of the agency’s changes to its collection of drug manufacturing data to make sure the information it obtains is complete and supports its efforts to deal with supply-chain vulnerabilities. The agency should collaborate with drugmakers and other government agencies and fight for the authority to obtain complete and necessary data from firms, if needed, the GAO said.

Read the full GAO report here: www.fdanews.com/01-28-21-GAO.pdf. — James Miessler