FDA Product Regulations Part 1 of 7

Summary

Dr. Chris Janesquez discusses FDA's role in regulating products for public health, including drug and biologic safety, efficacy, and security. He covers FDA's history, organizational structure, regulatory framework, and the product lifecycle from pre-clinical to post-marketing phases, highlighting the importance of guidances and international harmonization in ensuring safe and effective medical products.

Takeaways

• 📚 The FDA's mission is to protect public health by ensuring the safety, efficacy, and security of products like drugs, biological products, medical devices, and tobacco products.
• 🛡️ FDA plays a significant role in national security by ensuring the security of the food supply and fostering the development of countermeasures to public health threats, such as COVID-19 and monkeypox.
• 🔍 The FDA is organized into multiple centers focusing on specific products and has approximately 18,000 full-time staff, including scientists and other professionals, to fulfill its mission.
• 🏛️ Historically, tragedies have often led to legislative and regulatory actions, with the FDA adapting and evolving in response to events like the 1901 tetanus outbreak and the 1938 sulfanilamide disaster.
• 📈 The regulatory framework for medical products starts with laws passed by Congress, followed by FDA regulations, guidances, external standards, and internal operating procedures.
• 🌐 The International Council for Harmonization (ICH) develops guidances that help ensure safe, effective, and high-quality products and facilitate mutual acceptance of data across regions.
• 💊 The definition of a drug includes substances intended to diagnose, cure, mitigate, treat, or prevent diseases, and biological products are included within this definition.
• 🩺 A medical device is defined as an instrument or similar article intended to affect the structure or function of the body, not primarily through chemical action, and not dependent on being metabolized.
• 🧪 The product life cycle for drugs and biologics includes pre-clinical phases, clinical trials, submission for marketing approval, and post-marketing changes or additions.
• 📋 FDA guidances provide the agency's current thinking on regulatory compliance and are developed with public input, but they are not legally binding, allowing for flexibility in regulatory approaches.
• 🌟 The Prescription Drug User Fee Act and similar legislations facilitate the development and review of drugs, biologics, and devices by requiring manufacturers to pay for application reviews and setting performance goals for FDA.

Q & A

Who is Dr. Chris Janesquez and what is his role at the FDA?

Dr. Chris Janesquez is the Director of the Office of Regulatory Operations and the Associate Director for Review Management at the Center for Biologics Evaluation Research in the U.S. Food and Drug Administration.

What are the primary missions of the FDA?

The FDA's primary missions include protecting public health by ensuring the safety, efficacy, and security of the products it regulates, advancing public health through innovation, making medicines more effective, safe, and affordable, and providing accurate science-based information to the public.

How does the FDA contribute to the nation's counter-terrorism capabilities?

The FDA contributes to counter-terrorism capabilities by ensuring the security of the food supply and fostering the development of beneficial products to respond to deliberate, naturally occurring, or emerging public health threats.

What is the significance of the declared public health emergencies such as COVID-19 and monkeypox in the context of the FDA's role?

During declared public health emergencies, the FDA adopts an all-hands-on-deck approach to expedite the development and approval of therapeutics, vaccines, testing kits, and other modalities to diagnose and treat the public in response to the health crisis.

Can you describe the organizational structure of the FDA and its centers?

The FDA is organized into multiple centers that focus on specific products like drugs, biologics, veterinary medicine, and others. It also includes organizational components like the Office of Regulatory Affairs, which handles inspections for all FDA-regulated products.

What is the role of the Center for Biologics Evaluation and Research in the FDA?

The Center for Biologics Evaluation and Research is responsible for protecting and advancing the public health by ensuring the safety, efficacy, potency, and timely availability of biological products.

What are some of the historical events that have led to significant changes in FDA regulations?

Historical events such as the deaths of children due to contaminated diphtheria antitoxin in 1901, the elixir of sulfanilamide incident in 1937, and the Cutter polio vaccine incident in 1955 have all led to legislative and regulatory actions that have shaped FDA regulations.

What is the purpose of the International Council for Harmonization (ICH) and its role in FDA guidelines?

The ICH develops guidance in the areas of quality, efficacy, safety, and multidisciplinary topics to ensure safe, effective, and high-quality products. The FDA adopts ICH guidelines, which help facilitate mutual acceptance of data and harmonization of regulatory requirements across different regions.

What is the difference between a drug and a biologic as defined by the FDA?

A drug is defined as a substance intended to diagnose, cure, mitigate, treat, or prevent disease and is typically chemically synthesized. A biologic is a virus, serum, toxin, vaccine, blood component, or similar product used to treat or cure diseases and is manufactured through biological processes.

What are the stages of the product life cycle in the development and regulation of a drug or biologic as described in the script?

The stages include pre-clinical phase (discovery and laboratory testing), Investigational New Drug (IND) application, clinical development phases (Phase 1 for safety, Phase 2 for dose-finding and initial efficacy, Phase 3 for comprehensive safety and efficacy), and post-marketing phase (which may involve manufacturing changes, new indications, or dosage forms).

What is the significance of the Prescription Drug User Fee Act (PDUFA) mentioned in the script?

The PDUFA requires manufacturers of biologics and drugs to pay fees for applications and supplements for review. It is reauthorized every five years and provides additional resources and performance goals for the FDA to review and regulate medical products.