Experts advocate for modernization of FDA regulatory approach
The U.S. Food and Drug Administration (FDA) has been urged to “adopt significant fundamental changes to keep pace with medicine and technology” by Washington D.C. firm Epstein Becker Green and legal counsel from the mHealth Regulatory Coalition.
The law firm, known for its work with mHealth companies, submitted the request as part of a white paper submitted to the Office of the National Coordinator (ONC) for Health Information Technology. The 12-page paper comes in response to the ONC’s request for public comments as part of the development of health information technology regulatory framework in collaboration with the FDA and the Federal Communications Commission (FCC).
According to HealthcareITNews, the paper, titled Enhancing Innovation in e-Health through a Systems Approach to Regulation: A Blueprint for FDA Modernization, is calling on the FDA to update its regulatory approach as a result of the changing medical technology landscape.
As earlier reported on the Fountainhead Blog, the FDA has been involved in the regulation of mobile medical apps. Guidance for mHealth apps has been ongoing and many bodies are waiting for a cohesive decision to be made. Healthcare information technology stakeholders are waiting for the ONC, FDA and FCC to come up with the regulatory framework that was mandated by FDASIA.
The whitepaper focuses on the need for these three agencies to work together: "Having multiple agencies overseeing a particular industry creates a substantial risk of throwing sand in the gears of innovation through duplicative and disjointed regulation. It can be very hard to serve two masters, let alone three," the paper stated. "In the case of e-health, the government didn’t set out to have multiple agencies regulating product development, but through the convergence of the technology, FDA, ONC and FCC can all now find themselves regulating the same products."
The paper goes on to outline areas where the FDA should look to modernize and tighten their regulations. One example comes in the use of collaboration, saying the governing body should allow more alliances between vendors, clinicians and scientist in new technology development.
(image from biomet.com)
The authors of the paper believe that the FDA’s current regulatory system can address e-health after it has been modernized. Now the authors, along with the rest of the mHealth world, await the submission of the FDASIA’s findings, and more importantly, the final proposed strategy for presentation for Congress.