As technology continues to rapidly advance, it’s important for regulatory agencies like the U.S. Food and Drug Administration (FDA) to keep pace and adopt new technologies and approaches to support its public health mission and ultimately, better serve patients.
To fulfill commitments included in the goals letter associated with the recent Prescription Drug User Fee Act (PDUFA) VII agreement and requirements in the Consolidated Appropriations Act, 2023, the FDA released a request for information (RFI) as it prepares to publish its Data and Technology Strategic Plan later this year. Recently, PhRMA submitted comments to the FDA in response to this RFI.
The Strategic Plain aims to enhance the way the Agency gathers and analyzes data, as well as how it conducts reviews of potential new medicines critical for patient health. It will be important that the FDA works collaboratively with key stakeholders to ensure the best possible outcome.
Patients, industry and other key stakeholders will be best served by a modernized, technology-enabled, data driven approach to new drug and biologic submissions, data exchange and regulatory review. To that end, PhRMA believes there are three outcomes the Strategic Plan should work to help achieve:
- Expedited Drug Development and Enhanced Lifecycle Management: The current PDF-centric process for submissions, which follows a workflow based on paper, is static. Lifecycle management of these static filings is difficult, burdensome and subject to human error. Through structured, standardized data and advanced data analytics, the Strategic Plan can help to drive global harmonization, streamline the drug development process, reduce the time to product registration globally and improve life-cycle management.
- Promote Dynamic Data Exchange and Greater Interoperability: Currently, there is a need to develop data standards to help address interoperability between systems and between data sources that require further mappings and transformations. The Strategic Plan can help enable interoperability within a cloud-based ecosystem through support of a rapid and efficient exchange of information. It can also improve data interoperability between clinical care and research systems and data sources in the broader health care ecosystem.
- Enhance Concurrent Assessments Among Global Regulators: Cloud-based technology can be useful in enabling seamless dynamic data exchange and review among multiple stakeholders — transforming the current submission and regulatory review process. Enhanced concurrent assessments among global regulators could also help to facilitate patients across the world in getting earlier access to important medicines.
We look forward to working with the FDA as the Strategic Plan is developed and eventually implemented to ensure these efforts advance greater efficiency, capability and harmonization in drug development and expedite greater access to life-saving medicines for patients.
To read PhRMA’s full comments, visit here.
Rebecca Nebel PhD
Rebecca Nebel is a Deputy Vice President of Science and Regulatory Advocacy at PhRMA and leads advocacy efforts to advance FDA regulatory policy on key issues including digital health, regulatory information and technology, and combination products. Prior to joining PhRMA, Rebecca was the Director of Scientific Programs at the Society for Women’s Health Research and a project manager at the National Institutes of Health. She was also a Christine Mirzayan Science & Technology Policy Graduate Fellow at the National Academies of Sciences, Engineering, and Medicine. Rebecca received her PhD in biomedical sciences from Albert Einstein College of Medicine and her BS in biological sciences from Binghamton University.
Rebecca Nebel PhD
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How FDA’s modernization strategy could improve drug development
How FDA’s modernization strategy could improve drug development