Back from vacay in the middle of the week (and wishing I were still gone), I returned to find it was a comparatively quiet week on the whole, at least in our corner of the world around the workings of FDA. That said, there are a few things I wanted to note not only because they are big important issues, but really are demonstrative of the broad arc of change that is being constructed at FDA and which follow long-stated themes of the Commissioner. They are both, particularly the one regarding digital health, also representative of very complex issues where it is important to follow the incremental process or one can lose the thread entirely.
- Citizen’s Petitions and Gaming the Generics Approval Process – FDA Commissioner Gottlieb issued a statement this week on a subject that has been a theme for him when it comes to actions FDA can take to impact pricing. Generic approvals, which have been occurring at record rates in the past few years, are considered a primary means for FDA to participate in efforts to impact the price of medicines. The Commissioner has frequently used the phrase “gaming the process” to refer to tactics that might be employed to delay the entry of generics to the market – one of them being the filing of citizen’s petitions which though they rarely result in delaying market entry, do take up agency resources in the review. He announced the issuance of a revised draft guidance to describe the process by which FDA will consider a citizen’s petition to assess whether it has been filed for the purpose of delaying approval of a generic application.
- Gottlieb Update on Digital Health Regulation – As digital health devices and software rapidly advance, the Commissioner revisited the issue this week in a blog posting on FDA Voice – and because the area is not only evolving, but has many layers to it, getting periodic updates, overviews and explanations is not a bad idea. The premise is that FDA’s traditional approach to medical device regulation isn’t going to work in this era of software and sensor development that allow consumers to gather more data about themselves that may be medically useful. He distinguishes between the need to review a medical app and a review of the entire device upon which it sits. Further, when there is a need for review – as in the case of an app intended for a medical purpose – the agency is offering a review program designed to reduce the time taken. Finally, he notes that the agency will be seeking additional resources in the FY2019 budget to create a Center of Excellence of Digital Health to advance the pre-certification model that is now being put together by FDA that will include, among other things, a cybersecurity unit.
- FDA Clears First Hearing Aid to be Controlled by the User – The Bose Hearing Aid was cleared for marketing by FDA, a device that provides the user with control over both the fit and functionality of the hearing aid. A hearing aid user can adjust the hearing aid through the use of a mobile app from a smart phone, allowing for changes in real time by the user. FDA noted that the agency is in the process of drafting proposed regulations that would create a new OTC category of hearing aids. The device was reviewed under FDA’s de novo premarket review pathway designed for devices that are considered moderate risk devices that are novel and for which there is no prior legally marketed device.
Things to Keep an Eye on This Week
- October 10 – Oncologic Drugs Advisory Committee Meeting – Consideration of bio similar for treatment of NHL
- October 11 – Anesthetic and Analgesic Drug Products Advisory Committee – Consideration of candidate for treatment of moderate to severe pain in adults where intravenous opioid is warranted
Regulatory Developments in Pharma/Biotech/Devices/Food