Senate committee advances pandemic bill packed with FDA-related provisions

US health committee senators overwhelmingly voted to advance a bill that would lead to a slew of pandemic-related guidances from the Food and Drug Administration (FDA). The provisions of the bill give regulators authorities and directives to act faster in future public health emergencies.

On 15 March, the Senate Health, Energy, Labor and Pensions (HELP) committee voted 22-2 to approve the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act). Sens. Ron Paul (R-KY), and Mike Braun (R-IN) voted against the legislation that took a year to develop and incorporates 35 other bills.

While the PREVENT Pandemics Act touches on a broad range of pandemic issues, the section with the most impact on the US Food and Drug Administration (FDA) is title V of the legislation. It sets several new requirements for the FDA, including mandating the secretary of the Department of Health and Human Services to prioritize infectious disease drugs and biologics during a pandemic.

Medical product researchers faced a number of hurdles during the COVID-19 pandemic when trying to run clinical trials. To address those difficulties, the bill requires FDA to develop guidance that explains how validated digital health technologies can be used to continue clinical trials.

The bill would also require the agency to publish a guidance on how sponsors can use decentralized clinical trials for drug and device development. Such trials are meant to improve clinical trial participation and advance the use of flexible and novel trial designs.

FDA is further tasked with publishing guidance on how seamless, concurrent and other innovative clinical trial designs can be used to expedite development and review of drugs to address future public health emergencies. The agency is further directed to work with foreign regulators during such crises through memoranda of understanding or other arrangements to allow international regulatory harmonization.

The bill would also give FDA the power to expedite the development and review of medical countermeasures not just during a public health emergency but also during domestic and military emergencies.

Another issue the bill addresses is the development of diagnostic tests during a pandemic.

FDA has been criticized by lawmakers for not getting COVID-19 tests authorized faster during the pandemic.

The bill includes a provision that allows FDA to hire experts to help review in vitro diagnostic emergency use authorizations (EUAs), and the agency is required to publish a guidance on how such arrangements will work.

The PREVENT Pandemics Act includes a slew of other requirements for FDA that direct it to publish guidances such as using real-world evidence (RWE) during a public health emergency to get new products to market, platform technologies to develop new products and updating its website with more information about EUAs it has received and its subsequent actions.

Besides FDA, the bill also addresses many other issues that would impact medical device companies, including investing in medical countermeasure research and development, bolstering the US Strategic National Stockpile (SNS), ensuring registration of foreign drug manufacturers, strengthening the medical device supply chain, stopping counterfeit devices and more.

Paul and Braun tried to introduce a couple of last-minute amendments to the bill, including one that would require FDA to consider approving drugs and vaccines that have already been approved in countries with comparable regulatory oversight as the US.

"This is about taking the collective information across the world when it's working in a place where we would respect the process," said Braun.

HELP Committee Chair Patty Murray (D-WA) disagreed with the amendment and said it would compromise FDA’s ability to ensure the American public only have access to properly vetted safe and effective products.

“It's really critical we uphold the FDA’s gold standard of safety and effectiveness for drug products,” she said. “This amendment would actually lower the standard of US approvals of prescription drugs and it would also force the FDA to accept data from foreign clinical studies even when the quality and integrity of those studies do not meet FDA standards."

Ranking Member Richard Burr (R-NC) said he was reluctantly against the amendment.

“I served in Congress when we tried to harmonize FDA standards with the [European Union] and it sounded good on the surface but when you begin to look at all the members of the EU and all the different approval standards that some of their member countries had you realized that wasn't going to work with the gold standard set by the FDA,” he said. "I'm critical of how long the FDA takes, I'm critical of a lot of things the FDA does, but I'm not critical of the outcome that they reach."

Burr also argued that FDA does have the ability to use clinical trial data from outside the US to make regulatory decisions but until the COVID-19 pandemic has been reluctant to do so. He said he hopes the agency will continue to use foreign trial data beyond the current crisis.

Ultimately, the amendment failed to pass in a 16-6 vote.

Another regulatory amendment proposed by Paul was one to ensure FDA does not regulate laboratory developed tests (LDT). The agency has long sought to regulate certain LDTs arguing that they are too complex and carry a high level of risk, and some are mass-manufactured.

Murray and Burr however again urged against voting for that amendment, stating they are already working on a bipartisan legislation to address LDTs, referring to the Verifying Accurate Leading-edge IVCT Development Act of 2021 (VALID Act) and that the issue is better addressed in the upcoming FDA user fee reauthorization bill.

The committee ultimately voted 19-2 to table the amendment until it can be addressed in the user fee bill.

Finally, Braun also proposed an amendment initially proposed by Sen. Tom Cotton (R-AR) that would require FDA to create a registry to track all drugs and active pharmaceutical ingredients (API) produced outside the US. It would require federal health programs such as those run by the Department of Veterans Affairs and the Department of Defense to ensure most products do not come from China to curb reliance on drugs made in the country.

Murray raised concerns that doing so could lead to jurisdictional issues and have unintended consequences of limiting access to drugs for American patients. Burr also reluctantly urged voting against the amendment because it could potentially cause more harm.

Ultimately, the measure failed 19-3 and wasn’t included in the final version of the PREVENT Pandemics act.

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Senate committee advances pandemic bill packed with FDA-related provisions

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