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.