FDA official says pandemic reauthorization bill could drive VALID across finish line

Regulatory NewsRegulatory News | 13 January 2023 |  By 

A top US Food and Drug Administration (FDA) official said that a pandemic funding reauthorization bill could act as a vehicle for in vitro diagnostics reform and discussed other legislative priorities for the agency, such as getting more data about the supply chain to prevent future shortages.
For several years, FDA has sought explicit authority from Congress to regulate laboratory-developed tests (LDTs). Despite bipartisan support last year for the Verifying Accurate Leading-edge IVCT Development (VALID) Act, the bill was stripped from the user fee reauthorization package that was passed in September and was not included alongside other FDA reforms in the omnibus spending bill that was passed late last month. (Related: US FDA sees boost in FY23 budget proposal but no diagnostics reform, Regulatory Focus 20 December 2022)
FDA Commissioner Robert Califf has stated that the agency may consider developing a rule to give it regulatory oversight of LDTs but would prefer getting the authority from Congress. (Related: Califf: FDA may use rulemaking for diagnostics reform if VALID isn't passed, Regulatory Focus 25 October 2022)
Andi Lipstein Fristedt, deputy commissioner for policy, legislation and international affairs at FDA; spoke about the agency’s 2023 priorities during a 13 January webinar hosted by the Alliance for a Stronger FDA. She said that while the agency is considering the rulemaking process, there are still a number of “champions” of diagnostic and dietary supplement reform on Capitol Hill.
“These are priorities that I do fully expect that we'll continue to engage with Congress on,” said Fristedt. “We have really committed congressional champions on both of these, and I think that we will see continued interest in thinking about how to advance these priorities on the Hill.”
Fristedt noted that the Pandemic and All Hazards Preparedness (PAHP) Act is up for reauthorization this year and said that she “wouldn't be at all surprised” if lawmakers used it as a vehicle to get the VALID Act passed. She noted that a key takeaway for lawmakers during the pandemic has been that they realized how important diagnostics is to public health and may want diagnostics reform to be a part of the PAHP conversation.
"As Doctor Califf has said, especially when it comes to diagnostics, the current situation is untenable and we have made it clear that everything really remains on the table for the agency in terms of making sure that we are moving to a place where providers and patients can really have confidence in the diagnostics that they're using, and that they're accurate and reliable,” Fristedt added.
Another key issue for Fristedt is getting FDA authority to aggregate supply chain data from industry so the agency is better prepared to address potential product shortages. During the COVID-19 pandemic, a number of critical products faced shortages due to supply chain issues.
“I think that there can be a bit of a misunderstanding about how much information and data the FDA is entitled to under the law,” said Fristedt. “That's a place where we will certainly continue to work with Congress in thinking about what it looks like for the FDA to really continue to gain insight into the supply chains across the commodities that we regulate.”
On the global scale, Fristedt said that FDA’s priorities include leveraging and sharing regulatory information with trusted regulatory counterparts across the world. In particular, she noted that FDA and the Swiss regulatory agency, Swissmedic, signed an Agreement on Mutual Recognition on 12 January, which could allow the two regulators to use each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities to avoid duplicating inspections.
FDA has similar agreements in place with the European Union and the United Kingdom.
"It's such an important step in terms of being able to strengthen those global relationships and just have more efficiencies … and do more with less,” said Fristedt.
Fristedt said FDA is also excited about the African Union’s establishment of the African Medicines Agency (AMA). She added that FDA can now coordinate a lot of work with the AMA, which will be a big focus for the agency over the coming year. Similarly, she said FDA plans to prioritize work with the Organization for Economic Co-operation and Development (OECD) to mitigate the trade of illicit medical products.


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