The following statement was released today by Douglas B. Fridsma, MD, PhD, FACP, FACMI, President and CEO, American Medical Informatics Association (AMIA).
AMIA welcomes Dr. Scott Gottlieb as the new Commissioner of the Food & Drug Administration (FDA). Dr. Gottlieb brings a wealth of public- and private-sector experience to the position at a critical time. Strong leadership, supported by full Congressional funding, is critical for the FDA to implement provisions in the 21st Century Cures Act and deliver on the commitments outlined during the user fee negotiations.
Through a series of recent public meetings and guidance documents, FDA has signaled clear interest in leveraging informatics tools and methodologies to augment regulatory decision-making, improve patient safety, and protect public health. In both the MDUFA IV and PDUFA VI agreements, FDA clearly articulated the strategic imperative to:
- Enhance the use of consensus standards to facilitate exchange and use of health data;
- Improve patient engagement and the science of patient input;
- Advancing Model-Informed Drug Development;
- Enhancing and modernizing the FDA Drug Safety System;
- Leverage real-world evidence to improve regulatory decision-making and post-market surveillance; and
- Develop a framework for Digital Health for Software as a Medical Device (SaMD) and Software inside of Medical Devices (SiMD).
We fully support these efforts and believe AMIA members are well-positioned to help the FDA realize the tremendous value of real-world data to inform regulatory reviews and enable modern drug and device safety surveillance. As the only organization representing the views and expertise of clinical informatics in the FDA’s Network of Experts, AMIA stands ready to demonstrate how informatics can serve as a bridge between regulation and innovation. Through the systematic collection, analysis, and application of data, both the FDA and the private sector can better ensure that safe, effective and innovative products can improve the lives of patients.
Ongoing negotiations to reauthorize the User Fees Acts, and the urgent need to implement 21st Century Cures provisions, demands a seasoned leader and a commitment to FDA’s core mission.
AMIA looks forward to ensuring that informatics supports the FDA’s agenda in the critical coming months ahead.
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