Califf: FDA may use rulemaking for diagnostics reform if VALID isn't passed

Regulatory NewsRegulatory News | 25 October 2022 |  By 

Janet Trunzo (left) and Robert Califf (right)

BOSTON, MA – The US Food and Drug Administration (FDA) may look to notice and comment rulemaking to implement diagnostics reform if Congress fails to act, according to FDA Commissioner Robert Califf.
Janet Trunzo, AdvaMed senior executive vice president for technology and regulatory affairs, spoke to Califf on 25 October at the group’s annual Medtech Conference to talk about his vision for the agency. She asked the chief regulator what he planned to do if US lawmakers fail to pass the Verifying Accurate Leading-edge IVCT Development (VALID) Act as part of the December omnibus spending bill. (RELATED: AdvaMed seeks diagnostics reform in December budget bill, Regulatory Focus 13 October 2022)
“That’s a tough question,” said Califf. “You know, it’s not something we want to do because having a clear law passed leads to the best situation.”
“The other option besides the law is federal rulemaking – which is always an option for the FDA – but it is a very lengthy and contentious process,” he added. “It would be much better for the lawmakers to come to an agreement … but we also can’t stand by.”
FDA has long argued that it needs to regulate certain laboratory-developed tests (LDT) and issued a guidance on the matter during the final days of the Obama administration to use a risk-based approach to oversee such products.
The agency has long used its enforcement discretion to refrain from regulating most LDTs because these products have typically been simpler tests for low-risk conditions and were not mass manufactured. In recent years, however, regulators have argued that LDTs have become more complex, are meant to accurately diagnose serious diseases such as cancer and are being mass manufactured as kits and sold across the country.
Despite these concerns, FDA decided not to move forward with its proposed LDT guidance during the Trump administration, and instead issued a white paper outlining why regulating such tests is important. Former FDA commissioners, including Scott Gottlieb, who served as Trump’s first FDA commissioner, have supported regulatory oversight of the tests, though some have argued that doing so requires new legislative authorities.
Legislation on several issues, including the VALID Act, were stripped from the user fee reauthorization bill before it passed in late September. However, FDA and the industry lobby group, AdvaMed, are hoping to see some of those bills passed in December.
“Our politicians are having a lot of trouble getting along with each other, especially right now with the election coming up,” said Califf. “We’ll be working hard to try help people understand why some of these things are important [after the election].”
Other issues that the commissioner said are important to him include making sure the agency can quickly hire the additional staff that have been allocated under the user fee agreements, allowing the agency to conduct remote facility inspections and reforming its regulatory oversight of food.
He also highlighted some of the things he’s most excited about in the user fee reauthorization bill, including increased focus on patient-centered product development, the potential of the total product lifecycle advisory program (TAP) and significant funding to help FDA harmonize regulations with other jurisdictions. (RELATED: FDA Official: MDUFA V funding will help global harmonization efforts, Regulatory Focus 24 October 2022)
Califf said he’s happy FDA can help lead the way for global harmonization but is also cognizant of the different cultures and values that may come into play in that process. He noted that as a researcher who has worked on device and drug development that “one of the most frustrating things that can happen is when you get different directions from different agencies in different countries when you have a global industry.”
Trunzo asked Califf what unfinished business led him to come back to FDA after already having served during the Obama administration. He said he wants to advance a lot of cross-center work at FDA and ensure the agency leads the world in medical evidence generation especially since it now has the technology to do it.
“We no longer have the excuse that the technology isn’t there,” said Califf. “We now have the technology to know the benefits and risks of products that are in use in practice.”
“That of course gives us more freedom to accelerate considerations for approval when we know we’re going to get the information that we need on the backend,” he added. “But then we actually have to get the information that we need.”
Working with other agencies such as the Centers for Medicare and Medicaid, and the National Institutes of Health, the commissioner said he hopes the US can build the world’s best evidence-generation system. He also noted that the US has a lower life expectancy than many industrialized countries despite having access to some of the best medical products and spending more than $4.1 trillion on health care.
“We’re innovating and the rest of the world is using technology and innovation more effectively than we are,” said Califf. “There are many reasons to that, but my hope is that if we can figure out how to develop better evidence about what’s effective and what’s not then we can really focus our money and intensity on the effective products using the right circumstances.”
Califf was also asked about the fact that many staff at FDA have left during the pandemic.
During the early stages of the pandemic, the agency warned about burnout in its ranks. Though many people did leave, Califf noted that unlike his experience working for Google, FDA didn’t really see a “great resignation” that has plagued other organizations. He also noted that despite people being overworked and having to work remotely, the agency has never been more productive.
Califf said that FDA will be making some decisions in the next few weeks about the kind hybrid work environment it will adopt.
While regulators still want to be able to meet in-person, he noted that some of most valuable people at the agency are reviewers who may be semi-retired clinicians who have been able to work remotely during the pandemic since they don’t live in the Washington, DC, area.


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