On April 18, the House of Representatives Committee on Energy and Commerce, Subcommittee on Health held a hearing on draft legislation reauthorizing the FDA to collect “user fees” from pharmaceutical companies and medical device manufacturers seeking approval for new drugs and devices. The user fees, last authorized in FY 2008, provide an important source of funding for the FDA to review and approve applications in an expeditious manner. The draft legislative package also contains legislation authorizing the collection of user fees for generics and biosimilars and provisions to support the discovery pediatric pharmaceutical and antibiotics discovery, regulation of the pharmaceutical supply chain, and FDA’s ability to alleviate drug shortages, among others. Panelists were Dr. Janet Woodcock (FDA), Dr. Jeffrey Shuren (FDA), Dr. David Wheadon (PhRMA), Sara Radcliffe (BIO), Dr. David Gaugh (Generic Pharmaceutical Association), Joseph Levitt (on behalf of Advanced Medical Technology Association), and Allan Coukell (Pew).
The hearing itself was largely divided between the pharmaceutical industry and PDUFA (Prescription Drug User Fee Act) and medical devices and MDUFA (Medical Device User Fee Act). Dr. Woodcock fielded questions about PDUFA and issues such as: FDA’s regulation of the pharmaceutical supply chain (e.g. inspection of overseas manufacturing, counterfeit drugs), FDA’s response to drug shortages, and how to encourage development of new antibiotics and drugs for rare diseases.
Dr. Shuren handled questions about MDUFA and medical devices. While most questions were focused on broader concerns about the approval pathways for medical devices and whether or not they burdened manufacturers, members of the subcommittee also asked a number of questions regarding FDA’s regulation of medical software and mobile applications. Dr. Shuren noted that FDA is trying to remain sensitive to technological advances by opting not to exercise its regulatory authority broadly. Instead, FDA will continue to issue specific guidance to industry indicating in which cases and how extensively it will regulate medical software. For example, FDA has committed to regulating software that can impact patient safety at the point of care, such as an app that functions to turn a cell phone into a mobile ECG or one that receives and transmits information about a patient’s vital signs broadcast wirelessly by an implantable device.
Dr. Shuren indicated that changes to medical devices and software will only require reapproval from the FDA if they affect patient safety, effectiveness of the device, or represent a major technological advance. This way, regular software updates will not require reapproval, reflecting FDA’s understanding of the rapid innovation software often undergoes, even while on the market. Further, Dr. Shuren implied that the FDA would not like to see statutory changes to the definition of medical devices, preferring instead to use the agency’s discretion.
More information, including the testimony of the panelists, can be found on the subcommittee’s website.