FDA Stakeholder Update - Thursday September 19, 2019

Dear Colleague, FDA's Stakeholder Engagement Staff works to provide you with up-to-date information to further our commitment to advance public health and well-being.

FDA Announcements FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma FDA announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the Australian Therapeutic Goods Administration (TGA) and Health Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries. [09/17/2019]

FDA In Brief FDA seeks input on development and evaluation of abuse-deterrent formulations of central nervous system stimulants FDA issued a Federal Register notice to establish a public docket to receive comments from interested parties, including patients, patient advocates, health care professionals, academics, researchers, the pharmaceutical industry and other government entities on considerations related to the development and evaluation of abuse-deterrent formulations (ADF) of central nervous system stimulants and whether such products could play a role in addressing public health concerns related to prescription stimulant misuse and abuse. [09/19/2019] FDA continues steps to promote innovation in medical devices that help advance patient safety through the Safer Technologies Program and Request for Public Comments by November 18, 2019 FDA issued draft guidance titled “Safer Technologies Program for Medical Devices,” a voluntary program that is expected to significantly improve the safety of available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible for the agency’s Breakthrough Devices Program, but the use of which may be associated with serious or life-threatening risks. [09/18/2019] FDA issues final guidance to address ‘gaming’ by the use of citizen petitions FDA issued the final guidance, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act. It seeks to lessen the impact that FDA review of certain citizen petitions may have on any pending approval actions. The approach would help the FDA allocate resources efficiently when addressing petitions that are most likely to present an obstacle to the availability of generic drugs. If a citizen petition is received while a product application is already under review, and if the goal date for that review falls within the next 150 days, the guidance states that the FDA would expect to respond to that petition within 150 days. This policy aligns the FDA’s 150-day timeline to review and respond to these petitions described in section 505(q) with the timeline for review of the applications themselves. [09/18/2019] Upcoming Public Meetings

Meeting of the Pediatric and Drug Safety and Risk Management Advisory Committees Date/Time: September 26, 2019 - 9:00 am to 4:40 pm Date/Time: September 27, 2019 - 8:30 am to 1:30 pm Location: White Oak Campus: The Great Room, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993 The committees will discuss the required pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets, as mandated by law. On day two, the committees will hear information about safety signals associated with Singulair (montelukast), a medicine that has been approved for use in the U.S. since 1998 and is prescribed to over two million pediatric patients (infants to 16 years of age) each year for asthma or allergic rhinitis.   Public Meeting on Horizontal Approaches to Food Standards of Identity Modernization Date/Time: September 27, 2019 - 8:30 am to 5:00 pm Location: Hilton Washington DC/Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852 The purpose of this meeting is to give interested parties an opportunity to discuss FDA’s effort to modernize food standards of identity and to provide information about changes the FDA could make to existing standards of identity. FDA is particularly interested in changes that could be made across categories of standardized foods, often referred to as horizontal changes, to provide flexibility for manufacturers to develop healthier foods. Register for public meeting

FDA Voices FDA’s Comprehensive Response to HIV — Part I, by: Ned Sharpless, M.D., Acting Commissioner Our nation has been engaged in a battle against the HIV/AIDS epidemic since the early 1980’s. Over the past 37 years, we have learned a great deal about the virus, made important progress in the development of treatments and diagnostic tests, and remain resolute in our efforts to eradicate this disease. For those engaged in the field of public health, the AIDS crisis is a particularly instructive example of some of the ways such crises and responses to them evolve, particularly because this response coincides with our own medical training, development, and professional experience.

In 1990, I took time off from medical school to work in an HIV lab at the National Institutes of Health, studying what was then called “AIDS dementia.” My subsequent medical residency and fellowship occurred at the height of the AIDS epidemic, prior to the advent of many of our most important therapies for HIV infection, and I cared for many desperate patients dying from the disease. [09/18/2019]

FDA’s Comprehensive Response to HIV — Part II, by: Ned Sharpless, M.D., Acting Commissioner

As I discussed in the first part of this Voices article, the FDA is engaged on many fronts in the effort to combat HIV, applying its focus on the best available science, combined with important collaboration with many different stakeholders, industry, and patients. Yesterday I looked at some of the issues we are dealing with on the domestic front; today, I will examine some of the work we are doing globally.

Making a Global Impact Through PEPFAR FDA plays a pivotal role in advancing HIV therapies in underserved global markets through the President’s Emergency Plan for AIDS Relief (PEPFAR). The PEPFAR program was created in 2003 to address the global HIV/AIDS epidemic in the hardest hit countries.

PEPFAR was designed to bring together various federal government agencies that are involved in fighting the epidemic by creating a comprehensive unified response to provide the most comprehensive, coordinated, and targeted interventions. [09/19/2019] from CDER

New and Revised Product-Specific Guidances for Complex Generic Drug Product Development To support generic drug development and generic drug approval, FDA issues new and revised product-specific guidances (PSGs) on a quarterly and as needed basis. These PSGs, including PSGs for complex generic drug products, when finalized, describe FDA’s current thinking and expectations on how to develop generic drug products to specific reference listed drugs and are intended to assist the generic pharmaceutical industry with identifying the most appropriate methodology and evidence needed to support a specific generic drug’s approval. [09/16/2019]

from CFSAN Deputy Commissioner Champions More Digital, Transparent Food Safety System

In an initiative called the New Era of Smarter Food Safety, the FDA plans to continue efforts to modernize how it honors its commitment to help protect consumers from foodborne illness. The agency plans to incorporate the use of new technologies, tools and approaches as it continues to implement the science and risk-based requirements of the FDA Food Safety Modernization Act (FSMA).

One of the architects of the New Era is Frank Yiannas, a renowned food safety expert and proponent of a more digital and transparent food system. Mr. Yiannas joined the FDA from the private sector in December 2018. [09/17/2019]