On June 28th Congress approved and signed into law the Food and Drug Administration Safety and Innovation Act of 2012 (Bill S.3187). This Act renews and amends certain provisions of the Federal Food Drug and Cosmetic Act (FD&C) of 1938, the law that governs the FDA’s regulatory authority. It addresses drug, medical device, and health IT regulation, including regulation of mobile medical applications.
An important function of the Safety and Innovation Act is to extend to 2017 the assessment of user fees imposed on drug and medical device manufacturers. These fees support the operational and regulatory activities of the FDA and were first defined by the Prescription Drug User Fee Act of 1992 (PDUFA I). Drug fees were revised and renewed in 1997 (PDUFA II), 2002 (PDUFA III), 2007 (PDUFA IV) and again here (PDUFA V) as part of this Act. Medical device fees were first imposed by the Medical Device User Fee and Modernization Act (MDUFMA) of 2002, were renewed in 2007 as part of the FDA Amendments Act (MDUFA II), and again here (MDUFA III).
So what does this all have to do with mobile medical applications? Â Well, aside from renewing PDUFA/MDUFA, the Safety and Innovation Act of 2012 also contains important provisions that address medical device and health IT regulation, and specifically, the regulation of mobile medical applications. A new section in this Act sets up a basic framework for the development of future mobile medical application guidelines.
With the recent explosive growth of mobile medical applications, there has been considerable wrangling and debate over the precise role the FDA should play in the regulation of medical apps. Although the FDA took a first step towards health app regulation last year by issuing a mobile medical application draft guidance, a number of stakeholders – including industry participants, law makers, and other regulators have seen this as an overextension of the FDA’s mandate and have sought to limit the FDA’s involvement in this area.
Earlier this year, Senators Michael Bennet (D, Colorado) and Orrin Hatch (R, Utah) proposed an amendment to the Safety and Innovation Act that aimed to press the pause button on the FDA’s activities in mobile medical application regulation. The Senators’ amendment, known as the Bennet-Hatch amendment, sought to delay implementation of the FDA’s draft mobile medical application guidance until 2013, effectively putting a moratorium on mobile application regulation by the FDA.
Other stakeholders, such as the mHealth Regulatory Coalition (MRC), whose members include large telecoms like At&T and Verizon Wireless and many app developers, opposed the proposed moratorium and pushed for clearer and faster FDA guidelines on mobile medical application development. Their rationale was that lack of clear guidelines actually serves only to create confusion and hamper development and investment in this rapidly growing area. Developers and investors would rather know the exact regulatory requirements rather than stumble around in the dark, according to the MRC.
In the end, voices such as the MRC’s largely won the day. The final version of the Bill, approved by both the House and the Senate, did away with the language imposing a moratorium on the FDA’s draft guidance. In fact, the Bill mentions nothing of this guidance, in effect side-stepping the issue and implying that the FDA can build on it to further develop the final guidelines. Other provisions of the original Bennet-Hatch amendment were largely left in place, namely the requirement that the FDA collaborate with the National Coordinator of Health IT and HHS to create a guideline draft to be presented to Congress no later than 18 months after the Bill’s passing, in other words, before the end of 2013. The provision outlining the formation of an advisory Working Group composed of experts and industry stakeholders was also left in place, but the language was softened somewhat to leave its formation to the discretion of the HHS Secretary rather than to enforce it as written in the initial draft of the amendment.
The relevant section of the final Bill is included below for reference. The full text of the Bill can be found here.
Safety and Innovation Act of 2012 (S.3187), Title VI
Sec. 618 – Health Information Technology
(a) REPORT. Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary), acting through the Commissioner of Food and Drugs, and in consultation with the National Coordinator for Health Information Technology and the Chairman of the Federal Communications Commission, shall post on the Internet Web sites of the Food and Drug Administration, the Federal Communications Commission, and the Office of the National Coordinator for Health Information Technology, a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.
(b) WORKING GROUP.
(1) IN GENERAL. In carrying out subsection (a), the Secretary may convene a working group of external stakeholders and experts to provide appropriate input on the strategy and recommendations required for the report under subsection (a).
(2) REPRESENTATIVES. If the Secretary convenes the working group under paragraph (1), the Secretary, in consultation with the Commissioner of Food and Drugs, the National Coordinator for Health Information Technology, and the Chairman of the Federal Communications Commission, shall determine the number of representatives participating in the working group, and shall, to the extent practicable, ensure that the working group is geographically diverse and includes representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary.