Faculty Karl M. Nobert, Esq.

Food and Drug Regulatory Attorney

Washington, DC

Course Outline: Agenda

Day One (10:00am- 4:00pm EST )

• Overview of Drug Regulation in the United States
• Role and Function of FDA Generally
• FDA’s purpose and mission
• FDA’s jurisdiction
• FDA’s six “product centers”
• Center for Food Safety and Applied Nutrition (CFSAN)
• Center for Drug Evaluation and Research (CDER)
• Center for Biologics Evaluation and Research (CBER)
• Center for Devices and Radiological Health (CDRH)
• Center for Tobacco Products
• Center for Veterinary Medicine (CVM)
• FDA’s operation

Structure of FDA: Specifics of CDER

• CDER’s Mission
• CDER’s Jurisdiction
• CDER’s Organization (discuss divisions and duties within each office)

Intro to the FDCA, Regulations, and Guidance Documents

• Overview of FDCA and regulations
• Introduction to FDA guidance

OTC drugs v. Rx Drugs

• Differences between the two
• How to distinguish

History of Regulation of OTC Drugs in the US

• Statutory and Regulatory Authority for OCT Drugs
• 1906: Food and Drug Act
• 1938: Federal Food Drug Cosmetic Act (FFDCA) drug safety requirement.
• 1951: Durham-Humphrey Amendments to Federal Food, Drug and Cosmetic Act (FFDCA) designated drugs that cannot be used safely without professional supervision as prescription drugs and all other drugs as OTC.
• 1962: Drug Amendments
• In order for an OTC drug active ingredient to be included in an OTC monograph it must have been marked prior to May 11, 1972.
• Two legal pathways for OTC drug marketing post 1938.
• Marketing in compliance with drug monograph
• Marketing under the authority of an approved New Drug Application (NDA).
• Other Relevant Laws:
• The Federal Trade Commission Act
• The Fair Packaging and Labeling Act
• The Lanham Act
• State Laws

OTC Drug Review Process

• “Drug” Definition
• See 21 U.S.C. § 321(g)(1)
• Criteria
• Commercialization Pathways
• New Drug Approval Process
• The NDA
• An Rx-to-OTC Switch
• The OTC Drug Monograph Process
• New Drug Approval Process
• NDA
• Rare for a company to pursue an approved NDA for a non-prescription drug because of the expense and effort involved with obtaining FDA approval.
• Regulatory Procedure
• Rx-to-OTC
• The Rx-to-OTC Switch regulatory pathway is becoming increasingly popular as companies look for ways to extend the life cycle of their branded prescription products but similar to the option above, an Rx-to-OTC Switch requires FDA’s approval of an NDA.

• OTC Drug Monograph System
• Developed in the 1970’s in response to a whole class of marketed non-prescription drug products that existed in the market that had never been reviewed for safety and effectiveness.
• Attempt to “clean up” the market
• Development of the monograph process (or “OTC Drug Review”)
• OTC drugs as Generally Recognized as Safe & Effective (“GRAS&E”).

OTC Drug Monographs

• Definition & Purpose
• Policy Reasons Behind the Monograph Process
• Process
• Notice of Proposed Monograph
• Proposed Final Monograph
• Final Monograph

Final OTC monograph establishes the acceptable:

• active ingredients
• concentration of the active ingredients
• therapeutic claims
• indications
• labeling/warning requirements
• directions for use

Marketing the OTC drug product when the Monograph is not final

Day Two (10:00am - 4:00pm EST )

2020 Changes to the OTC Monograph System Under the CARES Act

• The FDA’s OTC Monograph Reform, Over-the-Counter Monograph User Fee Program (“OMUFA”), and Over-the-Counter Monograph Order Request (“OMOR”)
• What are Order Requests?
• Impact of Changes on Current OTC Monograph System
• What to do about product labels and labeling?
• Examples of Modifications as Applied to Existing OTC Product Categories

OMUFA and the Coronavirus Aid, Relief, and Economic Security (CARES) Act

• Complying with the FDA’s new OTC regulatory framework
• Advantages of a comprehensive, global strategy for regulatory compliance
• Exclusivity for OT

What to do about the Changes?

• Adapting to Required Changes
• Developing a Modification Plan Modifying Existing Systems
• Revising Standard Operating Procedures
• Best Practices for Mitigating Potential FTC, State and Third-Party Enforcement Risks
• Strategic Recommendations

Status of specific OTC Monographs, their included Regulatory Requirements and Strategies for Commercialization

• Antimicrobial
• Cold & Cough
• External Analgesic
• Internal Analgesic
• Laxatives
• Nasal Decongestant
• Skinning Bleaching
• Skin Protectants
• Sunscreens
• Other Monographs as appropriate.

OTC Drug Ingredients

• Classification
• Substantiating the safety and efficacy of a proposed new ingredient
• Showing why an Ingredient should be included in the Monograph
• The concept of GRAS

Marketing a drug product that deviates from a final monograph

• Suitability Petitions

OTC Drug Labels, Labeling, Marketing and Advertising Issues

• An OTC product's indications are limited to (a) those approved by FDA in the case of an OTC application or an Rx to OTC Switch product, or (b) the uses and indications included in the relevant monograph.
• Beyond those indications, other labeled uses and indications are not permitted.

Definitions of the terms “label” and “labeling”

Labeling includes the Immediate Container, Outer Packaging, Package Insert, Client Information Sheet, Shipping Label

Elements of an OTC Drug compliant label

• Active Ingredient
• Use
• Warnings
• Inactive Ingredients
• Purpose
• Directions
• Other Information

Promotional Materials

• Brochures, Press Releases, Flyers, Audio and Advertising
• Written Media, Broadcast Media, Internet Media, Social Media

Strategies for Regulatory Compliance

FDA Enforcement Actions

• Noncompliance and Enforcement
• FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution
• FDA’s Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy
• Local, State, and Tribal governments
• Types of Enforcement Actions
• Warning Letters and Untitled Letters
• Seizures
• Injunctions
• Monetary Penalties (21 USC §§ 303 and 307)
• Criminal Prosecution
• Debarment

Park Doctrine – Corporate Official Liability under FDCA

Overlapping Agency Jurisdiction – FDA, DOJ, FTC, USDA, and State Agencies

Learning Objectives:

Participants who attend this course will:

• Gain a comprehensive understanding of how OTC Drug Products are regulated in the U.S.
• Learn to distinguish between a potential Rx pharmaceutical product and an OTC drug.
• Recognize the difference between the various pathways for commercializing an OTC Drug Product.
• Understand how to identify and successfully navigate an OTC Drug Monograph.
• Recognize when reliance on a Proposed Rule, Final Rule and/or Drug Monograph is appropriate.
• Understand how to determine whether an Ingredient is considered Safe or GRAS/E for use in an OTC Drug and understand the difference between Category I, II and II Ingredient designations.
• Identify the required elements of a compliant OTC Drug Label.
• Take away strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks.
• Possess a working knowledge of the Rx-to-OTC Switch Process.
• Review and evaluate several of FDA’s current OTC Monographs.

Who Will Benefit

This includes individuals responsible for overseeing regulatory affairs, developing strategies for obtaining drug product approvals and those tasked with ensuring corporate compliance. Among others, this includes:

• Senior quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Production supervisors
• Manufacturing engineers
• Production engineers
• Design engineers
• Labelers and Private Labelers
• Contract Manufacturers
• Importers and Custom Agents
• U.S. Agents of Foreign Corporations
• Process owners
• Quality engineers
• Quality auditors
• Document control specialists
• Record retention specialists
• Medical affairs
• Legal Professionals
• Financial Advisors and Institutional Investors

About the Faculty Karl M. Nobert

Karl focuses his practice in FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages including dairy products, cosmetics, vitamins and dietary supplements, and veterinary products.

He has particular experience in the areas of prescription drugs and regenerative medicine, and has counselled numerous clients seeking FDA approval for Rx drugs and cellular-based products to treat both humans and animals.