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Mcdermott Will & Emery Update on Current FDA Policies and Priorities Vernessa Pollard MassMEDIC FDA Update December 12, 2017 www.mwe.com Boston Brussels Chicago Dallas Düsseldorf Frankfurt Houston London Los Angeles Miami Milan Munich New York Orange County Paris Seoul Silicon Valley Washington, D.C. Strategic alliance with MWE China Law Offices (Shanghai) ©2017 McDermott Will & Emery. The following legal entities are collectively referred to as "McDermott Will & Emery," "McDermott" or "the Firm": McDermott Will & Emery LLP, McDermott Will & Emery AARPI, McDermott Will & Emery Belgium LLP, McDermott Will & Emery Rechtsanwälte Steuerberater LLP, McDermott Will & Emery Studio Legale Associato and McDermott Will & Emery UK LLP. These entities coordinate their activities through service agreements. McDermott has a strategic alliance with MWE China Law Offices, a separate law firm. This communication may be considered attorney advertising. Previous results are not a guarantee of future outcome. Agenda . FDA Then and Now: New Administration and Leadership . Evolving Priorities and Initiatives . Implications for Industry? 1 FDA in the Trump Administration: Striking the Balance between Public Health and Politics? President Trump on FDA Executive Order . “We’re forced and focused on . Executive Order 13771 - accelerating FDA approvals. ”Reducing Regulation and We’re going to get the Controlling Regulatory Costs” approval process much (Jan. 30, 2017) faster.”1 – Directs agencies to repeal two existing regulations for every new regulation – Manage and limit regulatory costs and burdens 1 Statement of President Donald J. Trump, Meeting with Pharmaceutical Industry Executives, Jan. 31, 2017 2 FDA’s Leadership in the Obama Era Margaret Hamburg, M.D., 21st Commissioner of Food and Drugs . Physician . Former Assistant Director of the National Institute of Allergy and Infectious Diseases, National Institutes of Health . Former Commissioner of the New York City Department of Health and Mental Hygiene . Founding Vice President for Biological Programs and later the Senior Scientist for the Nuclear Threat Initiative . Longest-serving FDA commissioner since David Kessler . Succeeded by Dr. Robert Califf 3 FDA’s Priorities in the Obama Era New Legislation Key Priorities1 . Family Smoking Prevention and . Addressing Globalization Tobacco Control Act of 2009 – FDA Offices opened in China, India, Latin America and Europe . The Patient Protection and – Increased focus on Global cGMP inspections and Global GCP/BiMo Inspections Affordable Care Act of 2010 . Safety and Quality . The FDA Food Safety Modernization – Increased focused on safety of drug and food Act of 2011 supply chain – Greater emphasis on imports and foreign . The FDA Safety and Innovation Act suppliers (e.g., APIs, ingredients, components) of 2012 . Smart Regulation and Risk and Science- . The Drug Quality and Security Act of based decision-making 2013 – More focus on risk-based enforcement and prioritization 4 1 Source: FDA Strategic Priorities 2014-2018 (Sept. 2014) https://www.fda.gov/aboutfda/reportsmanualsforms/reports/ucm227527.htm New FDA Leadership in the Trump Era Scott Gottlieb, M.D., 23rd Commissioner of Food and Drugs . Physician . Former Advisor to Pharmaceutical and Medical Device Companies . Former Deputy Commissioner for Medical and Scientific Affairs . Former Senior Advisor to the FDA Commissioner . Former Senior Advisor to the Administrator of the Centers for Medicare and Medicaid Services 5 New Developments and Evolving Priorities . Innovation – 21st Century Cures Act – Digital Health and Medical Technology . Transparency and Access – Use of “Real world” data to support product development . Strategic Alignment of Agency Resources – Strengthening manufacturing oversight 6 21st Century Cures Act . New Law enacted December 13, 2016 . Designed to help accelerate medical product development and bring new innovations to patients who need them . Expedited FDA approval processes for novel biologics and medical devices . The law provides $500 million in new funding for FDA . Almost $10 billion in new funding for research and programs to address cancer, neurological diseases (e.g., Alzheimer’s) and opioid abuse 7 Key Device-related Cures Act Provisions . Section 3051 gives FDA explicit statutory authority to extend the existing priority review program for breakthrough devices to 510(k)s and de novo submissions . Section 3052 expands eligibility for the Humanitarian Device Exemption (HDE) and requires FDA to issue a draft guidance defining a “probable benefit” to health from the use of the device . Section 3053 requires FDA to train employees on the concept and use of recognized national or international standards for meeting premarket submission or other requirements . Section 3058 instructs FDA to consider the least burdensome appropriate means necessary in requesting information related to premarket approval applications . Section 3059 requires FDA to finalize a draft guidance describing when a manufacturer must submit a 510(k) for a modification or change to a device already on the market. Section 3060 carves out five types of medical software functions that will not be treated as devices 8 Advancing Digital Healthcare and Medical Technology . FDA’s Digital Health Innovation Action Plan – Provide timely access to high-quality, safe and effective digital health products, mobile applications and software – Redesign FDA processes and modernize tools to match the needs of digital health technology – Digital health pilot program to develop best practices for quality management . Several Recent Guidance Documents Issued – Draft Guidance: Clinical and Patient Decision Support (Dec. 8, 2017) – Draft Guidance: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (Dec. 8, 2017) – Final Guidance: Software as a Medical Device (Dec. 8, 2017) – Final Guidance: Deciding When to Submit a 510(k) for a Software Change to an Existing Device (Oct. 25, 2017) 9 Real World Evidence: A More Flexible Standard for Safety and Effectiveness? . “FDA needs to think of itself as a curator of information. Not just an arbiter” . “The fact is there’s often no single truth standard when it comes to the evidence used to support medical decisions.” . “The question for FDA is this: How do we make room for the wealth of evidence that can better inform our decisions, evidence that’s becoming more available, and more reliable? How do we fit RWE into our regulatory hierarchy?” Sources: Remarks by Dr. Gottlieb to the National Academy of Sciences on the Impact of Real World Evidence on Medical 10 Product Development https://www.fda.gov/NewsEvents/Speeches/ucm576519.htm Real World Data and Evidence to Support Product Development . Medical product developers are using Real world data (RWD) and Real world evidence (RWE) to support clinical trial designs – RWD: Relates to patient health status and/or the delivery of health care routinely collected from a variety of sources, including electronic health records (EHRs), claims and billing data, disease registries, patient-generated data, etc. – RWE: Clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD. Final Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Aug. 31, 2017) 11 Gene/Cell Therapy and Regenerative Medicine . Four Guidance Documents – Final Guidance: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception (Nov. 2017) – Final Guidance: Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue Based Products: Minimal Manipulation and Homologous Use (Nov. 2017) – Draft Guidance: Evaluation of Devices Used with Regenerative Medicine Advanced Therapies (Nov. 2017) – Draft Guidance: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions (Nov. 2017) Source: Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to 12 ensure proper oversight of stem cell therapies and regenerative medicine. What do these developments mean for Industry? . Potential Growth Sectors – Gene and Cell Therapy – Digital Health and Mobile Apps – Neuroscience – Opioid Abuse Countermeasures . Increased “Regulation” via Guidance versus Rulemaking . Areas of Continued Compliance and Regulatory Focus – Current Good Manufacturing Practice (cGMP)/Quality System Regulation (QSR) – Clinical Trials and Good Clinical Practice (GCP) – Marketing and Promotion (e.g., “off-label” claims, deceptive advertising) 13 What do these developments mean for Industry? Vernessa T. Pollard [email protected] 202-756-8181 14.
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