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In a recent interview, life sciences attorney Barbara Binzak Blumenfeld offers insights into significant recent legislative, judicial, and regulatory developments, including the planned end to the COVID-19 Public Health Emergency (PHE), the enactment of the Food and Drug Omnibus Reform Act (FDORA), and the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).
With a Ph.D. in molecular biology, Blumenfeld is well-versed in the scientific, ethical, and legal issues that are pivotal in the life sciences. In a recent interview, she touched on the expiration of the COVID-19 Public Health Emergency, the implications of the FDORA and PREVENT Pandemics Acts, and how these developments impact the life sciences industry.
Navigating the changes with FDORA and the PREVENT Pandemics Act
Barbara Binzak Blumendfeld
In addition to the expiration of the PHE, the passage of the Food and Drug Omnibus Reform Act (FDORA) and the PREVENT Pandemics Act has introduced various changes to regulatory law. FDORA addresses an array of topics relevant to pharma and biotech companies. “FDORA has provisions on biosimilars, accelerated approval, digital health use in clinical trials, rare diseases and the use of animal testing,” Blumenfeld said.
The PREVENT Pandemics Act strengthens the nation’s medical and public health preparedness and response framework, a crucial aspect in today’s world.
For FDORA, key areas of focus include marketing status reports, rare disease treatments and emerging technologies. Additionally, the legislation has ramifications for pharmaceutical manufacturing, cell therapies and nonprofit pharmaceutical organizations. Furthermore, it covers accelerated approval, and infectious disease product innovation.
Considerations for accelerated approvals
“In terms of the accelerated approval, it gives FDA more control over the start and completion of trials required post-approval for something that got an accelerated approval,” Blumenfeld said. “So by that, the statute doesn’t require it, but it says that FDA may, for instance, require that a sponsor already has its confirmatory studies going on at the time they get their accelerated approval.”
Blumenfeld emphasized that the FDA has historically observed that some sponsors can be slow to initiate confirmatory studies for products in the accelerated approval pathway. This new provision thus allows the FDA to make sure the study is already underway before granting accelerated approval. She also mentioned that the FDA will have the authority to request regular updates on the status of post-approval studies and will create an internal group to ensure consistent use of the accelerated approval pathway across various product areas. Additionally, FDORA mandates that the FDA issue guidance within a specified time frame to help the industry understand its new responsibilities.
Traditionally, it has been rare for FDA to pull an approval of a product winning accelerated approval. “What is unclear to me is if this legislation change will make it more likely that FDA will pull approval in the future,” Blumenfeld added. “I think it’s meant to get people to comply with all of the accelerated approval requirements.”
However, Blumenfeld believes “the devil is in the details” regarding FDA implementation and whether the agency will act on new tools like requiring confirmatory studies before approval. She highlighted that “there’s been some congressional pushes, as evidenced by FDORA,” indicating concerns about using the accelerated approval pathway correctly.
Understanding the impact of PHE expiration
The Public Health Emergency (PHE) is set to end on May 11, a fact that could have ramifications for many life science companies, including drug and device companies. “The important thing that people need to remember is that the end of the public health emergency is not the same as the end of the emergency use authorization (EUA) declaration,” Blumenfeld said.
After May 11, EUAs that FDA has already granted will remain in effect for the time being, and the agency will be able to grant new EUAs. “We don’t know when FDA is going to end the EUA declarations, but the agency has stated that it intends to publish a notice 180 days before doing so,” Blumenfeld added.
In addition, the FDA published in March a Federal Register notice, categorizing all the guidance documents issued during the pandemic. “They lumped them into several categories,” Blumenfeld said. Some guidances are set to end on May 11, while others will remain in effect permanently In the middle category, there is a large group of guidance documents whose fate remains uncertain. Some will end 180 days after the PHE ends, while others will continue for 180 days after the PHE ends. “During this time, the FDA will assess whether these documents should be further modified and remain in effect longer,” Blumenfeld.
“FDA is already looking forward to all of these categories of guidance,” Blumenfeld. In the interim, life science companies should monitor the status of these various guidance documents and be prepared for the implications of the FDORA and PREVENT Pandemics Acts, she counseled.
Filed Under: Biologics, Cell & gene therapy, clinical trials, Drug Discovery and Development, Immunology, Infectious Disease, Regulatory affairs
