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Friday, November 8, 2024

Waltz Questions FDA’s Telework Policies

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Congressman Michael Waltz | Michael Waltz Official Website

Congressman Michael Waltz | Michael Waltz Official Website

U.S. Congressman Mike Waltz has raised concerns about the telework policies at the U.S. Food and Drug Administration (FDA), stating that they have had a negative impact on the agency's ability to approve critical drugs and therapeutics. In a letter addressed to Commissioner Robert Califf, Waltz emphasized the need for federal agencies to fully reopen and provide necessary services to the American public.

"It has been four years since the pandemic hit our country yet a number of federal agencies that adopted telework policies have still not fully reopened to serve the American public," said Waltz. "This has especially harmed much-needed services from the FDA as the agency continues to restrict required in-person meetings needed to approve medical therapies for the American public. It’s past time to reopen!"

Waltz highlighted the impact of telework policies on the FDA's Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). According to him, these policies have minimized the agency's operational standards for approving critical drugs and therapeutics. He expressed concerns about the delay in service and response times from federal agencies due to elevated levels of telework.

In his letter, Waltz questioned Commissioner Califf about the effectiveness of the FDA's telework policies. He pointed out that the FDA's decision to implement a hybrid work environment, optimized for productivity and lifestyle, has significantly affected the timeliness and quality of CDER and CBER meetings. He raised concerns about the restricted number of participants allowed to speak during these meetings and the limited availability of conference rooms at the FDA's White Oak campus.

Waltz requested clarification on several points, including the impact of limited conference room availability on the FDA's ability to conduct meetings, the FDA's compliance with COVID-19 vaccine guidelines for its employees, and the number of in-person meetings granted by CDER and CBER before and after the COVID-19 pandemic. He also questioned the reasons behind the FDA's reluctance to hold fully in-person meetings in conference rooms that have not been upgraded with hybrid technology.

The congressman also sought information on the FDA's expenditure on upgrading conference rooms to support hybrid meetings and the agency's plans to bring employees back to full capacity. He referred to a letter from White House Chief of Staff Jeff Zients, urging Cabinet officials to "aggressively execute" plans for federal employees to return to in-person work.

Waltz concluded the letter by expressing his expectation of a response from Commissioner Califf. It remains to be seen how the FDA will address these concerns and whether any changes will be made to the agency's telework policies.

In summary, Congressman Mike Waltz has questioned the telework policies at the FDA, highlighting their impact on the agency's ability to approve critical drugs and therapeutics. He has called for federal agencies to fully reopen and provide necessary services to the American public. Waltz has raised concerns about the restricted in-person meetings and limited availability of conference rooms at the FDA's White Oak campus. He has requested clarification on various aspects of the FDA's telework policies and its plans to bring employees back to full capacity.

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