August 19, 2019

August 19, 2019

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August 16, 2019

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FDA 2018 Year in Review

Introduction

The US Food and Drug Administration’s (FDA’s) 2018 regulatory agenda spurred significant activity throughout the year, including implementation of several initiatives and mandates required by the 21st Century Cures Act (Cures Act). FDA continues to take measures to reduce regulatory barriers to market entry for innovative products, and it is leveraging traditional administrative processes, such as the citizen petition process, to advance its policy goals, including increasing generic competition. FDA initiated targeted enforcement actions in areas of traditional focus, such as good manufacturing practice (GMP) compliance, but it also signaled renewed focus on tobacco advertising, unapproved stem cell procedures, and compounding. FDA also issued important guidance documents throughout 2018.

This Special Report reviews notable actions that shaped FDA-regulated industries and products last year and offers insight into the agency’s 2019 priorities and expected actions.

  1. Drugs

  2. Digital Health

  3. Drug Quality Security Act Implementation

  4. Drug Supply Chain Security Act

  5. Medical Devices

  6. Laboratory-Developed Tests and Precision Medicine

  7. Food

  8. Tobacco

  9. Cannabis

  10. Advertising and Promotion

  11. Clinical Investigations

  12. Manufacturing and Good Manufacturing Practice

  13. Enforcement

The Year Ahead

FDA’s activities and initiatives in 2018 suggest that 2019 will bring greater focus on data strategy; patient perspectives; and innovative ways to leverage data to influence product development, risk management and regulatory decisions. The agency’s focus on data may lead to greater emphasis and renewed focus on data integrity and data quality issues throughout the product lifecycle, from clinical research to manufacturing. The continued focus on novel products and new expedited review processes for digital health, regenerative therapies and novel devices may mean fewer barriers to market entry for novel products, but it may also mean more significant post-market data collection and surveillance requirements. Policy and regulatory initiatives on cybersecurity and interoperability suggest the possibility of increased enforcement and scrutiny of these issues in standard quality and cGMP inspections. While warning letters and other FDA enforcement actions remain static, the agency appears to be leveraging procedural and administrative processes to influence broader policy objectives in areas such as drug pricing and generic competition. Life sciences companies may benefit from greater flexibility regarding the use of data from nontraditional sources to drive product development, advertising and promotion and quality. They may also benefit from the availability of a number of means to engage in pre-development and pre-submission discussions with the agency.

© 2019 McDermott Will & Emery

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About this Author

Vernessa Pollard Pharmaceutical Attorney McDermott
Partner

    Vernessa T. Pollard is a partner in the law firm of McDermott Will & Emery LLP and is based in the Washington, D.C., office. Vernessa serves as co-head of the Firm’s Food and Drug Administration (FDA) practice.

    Vernessa advises companies on regulatory, compliance, enforcement and legislative matters involving pharmaceuticals, medical devices, digital and mobile health, health IT solutions and services, and emerging technologies and software. She also advises national and international food and cosmetic producers and retailers on...

    202-756-8181
    Veleka Peeples-Dyer, McDermott Will Emery, life sciences industry, FDA attorney, drug safety lawyer, health care fraud counsel,
    Partner

    Veleka Peeples-Dyer is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm's Washington, D.C., office. She is an experienced attorney with an extensive background in the Life Sciences Industry, including Food and Drug Administration (FDA) regulation, clinical trials, manufacturing and supply, drug safety, licensing, product acquisition due diligence, health care fraud and abuse and compliance matters. Additionally, Veleka’s experience includes conducting internal investigations, developing and implementing legal and compliance training programs and advising on federal and state transparency, lobbyist and disclosure issues, including the Federal Physician Payments (Sunshine) Act.

    Veleka previously worked as in-house counsel to publicly-traded biotechnology and pharmaceutical companies. She served as a strategic business and legal advisor, counseling on the full range of research, development, regulatory, compliance and commercialization issues that biotechnology and pharmaceutical companies face. Veleka’s earlier corporate counsel experience includes working in the government contracts and utilities industries. Veleka understands the challenges clients face in this industry by providing strategic and practical counsel on the challenges and business complexities that life sciences companies face.

    202-756-8639
    T Reed Stephens Attorney McDermott Will
    Partner

    T. Reed Stephens is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm's Washington, D.C., office.  Reed represents clients involved in the Life Sciences industry, including pharmaceutical and biotech manufacturers, wholesalers, and individuals, as well as health care systems and non-health care related companies in the financial services industry.  In addition to representing clients in matters involving state and federal government law enforcement, voluntary disclosures, and congressional investigations Reed advises clients on mergers...

    202 756 8129
    Michael Ryan Attorney specializing in Pharma law McDermott Law Firm
    Partner

    Michael W. Ryan is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. office.

    Michael focuses his practice on the legal, regulatory and reimbursement issues that manufacturers and investors encounter in the development and commercialization of pharmaceuticals, medical devices, biotechnology products and laboratory services.  Michael counsels entities as they seek to obtain authorization to market their products from the U.S. Food and Drug Administration, maintain compliance with applicable laws and regulations (including the...

    +1 202 756 8088
    Anisa Mohanty, McDermott Law Firm, Health Care Attorney
    Associate

    Anisa Mohanty advises life sciences companies on regulatory, compliance, enforcement, policy, and legislative matters arising under the Federal Food, Drug, and Cosmetic Act (FDCA). She counsels pharmaceutical, medical device, and consumer product companies on premarket pathways, advertising and promotion, and current Good Manufacturing Practice (cGMP) and Quality System requirements. Anisa also assists clients with US Food and Drug Administration (FDA) engagement strategies and responding to FDA administrative and enforcement actions. 

    202-756-8286