The U.S. Senate has confirmed Scott Gottlieb, MD, to head the Food and Drug Administration in a 57-42 vote.
Gottlieb, who served in the Bush administration as the FDA’s deputy commissioner for medical and scientific affairs from 2005 to 2007, takes the helm of the regulatory agency at a pivotal time, according to Doug Fridsma, MD, president and CEO of the American Medical Informatics Association.
“Dr. Gottlieb brings a wealth of public- and private-sector experience to the position,” said Fridsma in a written statement. “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.”
The FDA is authorized to collect user fees from medical device manufacturers, and in exchange, the agency commits to meeting certain performance goals. The current Medical Device User Fee Amendments (MDUFA) will expire in September and must be reauthorized before then for five more years. The MDUFA IV agreement, negotiated between FDA and the medical device industry, requires Congressional authorization for fiscal years 2018 to 2022.
As part of the MDUFA IV agreement, the agency has committed to develop a framework for digital health for Software as a Medical Device (SaMD) and Software inside of Medical Devices (SiMD). In particular, the MDUFA IV agreement stipulates that the FDA will “explore opportunities to establish premarket approval and clearance pathways tailored to SaMD, SiMD and novel digital health technologies that take into account real-world evidence,” Fridsma notes.
Among other activities, the agency has agreed to publish a draft revised version of the 2005 “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” by the end of fiscal year 2019 and—within 12 months of the close of the comment period—publish the final revised version.
“The user fee negotiations have very specific deliverables,” says Bakul Patel, associate director of digital health in the FDA’s Center for Devices and Radiological Health. “The commitment is that we will finalize the guidance on the software modifications.”
Further, the FDA will participate in “international harmonization” efforts related to digital health, including work on developing SaMD and other digital health convergence efforts through the International Medical Device Regulators Forum. “That refers specifically to IMDRF efforts that we have already been working on,” adds Patel, who contends that the agency is committed to working globally on digital health.
Fridsma said he is encouraged by the FDA’s strategic imperative to promote consensus standards to facilitate exchange and use of health data, as well as utilizing real-world evidence to improve regulatory decision-making and post-market surveillance.
“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,” Fridsma added. “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.”
In addition, Fridsma noted that the “FDA has signaled clear interest in leveraging informatics tools and methodologies to augment regulatory decision-making, improve patient safety, and protect public health” and that “AMIA looks forward to ensuring that informatics supports the FDA’s agenda in the critical coming months ahead.”
Health IT Now, a coalition of patient groups, providers, employers and payers that support HIT, congratulated Gottlieb on his confirmation by the Senate.
“Throughout this process, he has demonstrated a willingness to embrace new technologies and ease barriers that stand in the way of innovation, all while protecting patient safety,” said Joel White, executive director of HITN. “On behalf of Health IT Now and our nearly 60 member organizations, we look forward to working with Dr. Gottlieb to advance our shared goals of full interoperability, an end to the harmful practice of information blocking, and a more modernized healthcare experience for patients and providers alike.”
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