Press Releases

WASHINGTON, D.C. –  On Wednesday, U.S. Congressman Mike Waltz (FL-06) sent a letter to Commissioner Robert Califf of the U.S. Food and Drug Administration (FDA) to question the telework policies at the FDA, which have minimized the operational standards for approving critical drugs and therapeutics.

“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!”

Read the full letter:

Dear Commissioner Califf,

I write today concerning the telework policies at the Food and Drug Administration (FDA), particularly within the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), which have minimized the FDA’s operational standards for approving critical drugs and therapeutics.

The COVID-19 pandemic forced most industries to adopt telework models as a necessary safety precaution for employees and the federal government was no different. Since then, we have seen some employers maintain telework structures for a variety of reasons. However, the benefits seen in some fields through telework are not applicable to every industry.  The reality is that most federal employees cannot adequately perform their job duties without working in-person. As our federal agencies maintain elevated levels of telework, the American people continue to suffer from delays in service and response times from those paid to serve them.

Despite the significant problems seen with maintaining telework at our federal agencies, you have continued to promote these ineffective policies as leader of the FDA – an agency with a pivotal role in protecting the health and safety of the American people. In February 2023, you released a public statement [CR1] touting the FDA’s decision to “construct a hybrid work environment, optimized for productivity and lifestyle.” This hybrid workplace model has significantly altered the timeliness and quality of CDER and CBER meetings granted to companies seeking to advance critical therapies for patients. Rather than holding in-person meetings that foster important, meaningful discussions and interactions on the scientific complexities of proposed treatments, CDER and CBER are now only holding confined hybrid meetings. As noted in the FDA’s standard email to granted meeting recipients, this hybrid meeting format restricts the number of participants allowed to speak during the meetings as well as the number of participants allowed to attend in-person[RA2] . Further, the standard email informed recipients that the FDA’s White Oak campus has a limited number of conference rooms available to hold these meetings as they work to upgrade the existing rooms with the technology and equipment necessary to support the hybrid meeting format[RA3] .

In order to gain additional insight as to how the FDA’s hybrid workplace model is optimal for “productivity and lifestyle” for the Agency overall and to gain some clarity on what benefits your policies provide to the American people, I respectfully ask the following:

1.    Has the limited availability of conference rooms delayed FDA’s ability to conduct CDER and CBER meetings?

2.    Has the FDA complied with COVID-19 vaccine guidelines and policies for its employees, as recommended by the Centers for Disease Control (CDC)? If so, why is the FDA maintaining COVID-19 restrictions through the limited hybrid meeting model utilized by CDER and CBER?

3.    Prior to the COVID-19 pandemic, how many in-person meetings were granted by CDER and CBER annually? Since the end of the COVID-19 National Emergency, how many in-person meetings were granted?

4.    Understanding that the FDA granted in-person meetings without a hybrid component prior to the COVID-19 pandemic, what is preventing CDER and CBER from holding granted meetings fully in-person in the conference rooms that have not been upgraded with the hybrid technology?

5.    How much has the FDA spent thus far to upgrade conference rooms across the agency to support a hybrid meeting component? How much do you estimate the FDA will spend upon completion of all planned upgrades?

6.    If FDA employees are now required to work in-person, what is preventing CDER and CBER from allowing fully in-person meetings with no attendee restrictions for granted meetings that request full participation?

7.    In August of 2023, White House Chief of Staff Jeff Zients wrote to Cabinet officials calling on them to “aggressively execute” plans for federal employees to return to in-person work.[1] What are you doing to bring your offices back to full capacity? When can the American people expect the FDA to be working on-site fully?

Thank you for your attention to this matter and I look forward to your response.