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# Califf Sails Through 1st Covid Oversight Hearing
- URL: https://www.fdaweb.com/califf-sails-through-1st-covid-oversight-hearing/
- Published: 2023-02-08T12:00:00.000Z
- Updated: 2026-09-14T18:15:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153737

What was shaping out to be a contentious 2/8 House oversight hearing on FDA and other health agencies’ (NIH, CDC) responses to the Covid-19 health emergency ended up being rather manageable for FDA commissioner **Robert Califf**. This was Califf’s first hearing in the new Congress with its Republican-led House subcommittees, and he seemed to handle the lawmakers' criticism like a seasoned pro.

At the opening of the joint Energy and Commerce Oversight and Investigations and Health Subcommittee Hearing, full committee chair **Cathy Rodgers** (R-WA) criticized FDA’s pandemic response, saying it “failed to alleviate concerns about the vaccine… Beyond the vaccine, FDA inspections of foreign sites are woefully lacking, innovators can’t get the guidance they need to meet approval standards, and patients are the ones left without the innovation or supply of products they need.”

Interestingly, one of the first criticisms lodged by lawmakers came from **Diana DeGette** (D-CA) on the agency’s use of advisory committees, which she said was confusing for the American people. “It seemed to me that there was a lack of balance between the ultimate decision maker and the advisory committee,” she said, asking Califf if there should be some streamlining of advisory committees to make them more practical.

“Advisory committees are like democracy. It’s messy,” a witty Califf responded. “The FDA full-time staff need to interact with outside experts in a structured manner, but you’re right, they are advisory and they’re not decision making. Regulatory decisions are made by full-time civil servants who don’t have a conflict of interest financially, and their mission is preserving and protecting public health. We are looking across the FDA right now at what we can do,” he said, to optimize the use of advisory committees and make it better because they provide important and critical input.

Committee chair Rodgers told Califf that her constituents have been complaining about FDA’s lack of face-to-face meetings for medical product innovators and asked when the agency will permit these now that the public health emergency is ending. Califf noted that the agency recently restored requests for in-person meetings and some are being scheduled ([see earlier story](https://www.fdaweb.com/cder-cber-restarting-in-person-industry-meetings/)). He said that in conversations with industry, they have requested a hybrid approach of having some meetings in person and some via Zoom conferencing because the ability to have a meeting on the spot via Zoom is sometimes superior to trying to get a group of people to FDA’s headquarters.

Califf was asked to address why the agency needs authorization to regulate laboratory-developed tests, which was sought during the user fee reauthorization but did not get added in the end. He said FDA wants to spur innovation by having labs and academic medical centers develop new tasks as new viruses arise. “On the other hand,” he explained, “the quality that's needed in these tests is very important because if you get the wrong answer and you get the wrong treatment, then that’s a tragedy. And so, we need a framework for regulating laboratory tests that enables and spurs innovation but also protects the public from tests that are bad. And as I've already mentioned, in areas like molecular testing, over half the tests that we saw once the gates were open to allow them out, turned out to have major problems.”

Additionally, Califf was asked to address the many vacancies in FDA offices in China and India, which has been estimated that about a third of the drug investigator positions there are vacant. He said that due to the recent omnibus spending bill, the agency now has “additional hiring authority in these areas to bring on more people and we’re hard at work in doing that. The number of inspections is growing daily now and we’re catching up to what was lost during the pandemic. Particularly in China, this has been a big issue because of a lack of access to entry into China until very recently… It is a global supply chain and it’s fragile… I’ve done a lot of work in China and India in my previous life in academia and industry and we’ve got to be there because that’s where a lot of our supplies are coming from now, whether we like it or not, and I hope we can also fix that and bring more of that back to the U.S.

In Califf’s prepared testimony, he said enhancing FDA’s regulatory capabilities and readiness to respond to emerging pathogens is necessary so that it can “expeditiously review new vaccines, existing vaccines and other medical products… Through the creation of a specialized program within CBER to defend against emerging pathogens, the agency would be well positioned to respond to identified threats of concern and focus experienced resources to work quickly on MCM \[medical counter measures\] development to address these concerns. In consultation with HHS partners, the program could: provide recommendations and guidance to developers of vaccines and other medical products and relevant federal partners; use real-world data or real-world evidence to study the safety and effectiveness of products for addressing biological incidents and identify which products may be best suited for specific pathogens or for use in different populations; and facilitate product development including advances in manufacturing.”

Califf also wrote that FDA’s ability to monitor vaccine safety could be boosted by a “coordinated federal public health data reporting authority.” FDA’s current Biologics Effectiveness and Safety (BEST) Initiative taps into information from millions of health insurance claim submissions or electronic health records has limitations, according to Califf, adding that its ability to analyze claims information is challenged because some vaccinations are not recorded in health insurance claims data. “When we request records to verify adverse events detected by the BEST Initiative databases it has taken FDA around 8-12 weeks in some cases to receive voluntary access to these records,” he testified. “Additionally, coordinated federal public health data reporting authority would help the agency to more swiftly identify adverse event patterns and trends associated with the use of vaccines or other MCMs, and swiftly be able to communicate with health care providers and patients about safety signals.”

To view Califf’s prepared remarks, click [here](https://www.fda.gov/news-events/congressional-testimony/federal-response-covid-19-02082023?ref=fdaweb.com). To view a video of the full hearing, click [here](https://youtu.be/0y2XV1qox0c?ref=fdaweb.com).