FDA's Regulation of OTC Drug Products

1. Overview of Drug Regulation in the United States
1. Role and function of FDA generally
1. FDA’s purpose and mission
2. FDA’s jurisdiction
3. FDA’s six “product centers”
1. Center for Food Safety and Applied Nutrition (CFSAN)
2. Center for Drug Evaluation and Research (CDER)
3. Center for Biologics Evaluation and Research (CBER)
4. Center for Devices and Radiological Health (CDRH)
5. Center for Tobacco Products
6. Center for Veterinary Medicine (CVM)
4. FDA’s operation
2. Structure of FDA: Specifics of CDER
1. CDER’s mission
2. CDER’s jurisdiction
3. CDER’s organization (discuss divisions and duties within each office)
3. Introduction to the FDCA, Regulations, and Guidance Documents
1. Overview of FDCA and regulations
2. Introduction to FDA guidance
2. OTC drugs v. Rx Drugs
1. Differences between the two
2. How to distinguish
3. History of Regulation of OTC Drugs in the US
1. Statutory and Regulatory Authority for OTC Drugs
1. 1938: Federal Food Drug Cosmetic Act (FFDCA) drug safety requirement.
2. 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.
3. 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.
4. Two legal pathways for OTC drug marketing post 1938.
1. Marketing in compliance with drug monograph
2. Marketing under the authority of an approved New drug application (NDA).
4. OTC Drug Review Process
1. New Drug Approval Process
1. NDA
1. 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.
2. Rx-to-OTC
1. 1. 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.
2. OTC Drug Monograph System
1. 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.
2. Attempt to “clean up” the market
3. Development of the monograph process (or “OTC Drug Review”)
4. OTC drugs as Generally Recognized as Safe & Effective (“GRAS&E”).
5. OTC Drug Monographs
1. Process
1. Notice of Proposed Monograph
2. Proposed Final Monograph
3. Final Monograph
2. Final OTC monograph establishes the acceptable:
1. active ingredients
2. concentration of the active ingredients
3. therapeutic claims
4. indications
5. labeling/warning requirements
6. directions for use
3. Marketing the OTC drug product when the Monograph is not final
6. Policy Reasons Behind the Monograph Process

7. Status of specific OTC Monographs, their included Regulatory Requirements and Strategies for Commercialization
1. Antimicrobial
2. Cold & Cough
3. External Analgesic
4. Internal Analgesic
5. Laxatives
6. Nasal Decongestant
7. Skinning Bleaching
8. Skin Protectants
9. Sunscreens
10. Other Monographs as appropriate.
8. OTC Drug Ingredients
1. Substantiating the safety and efficacy of a proposed new ingredient
2. Showing why an Ingredient should be included in the Monograph
3. The concept of GRAS
9. Marketing a drug product that deviates from a final monograph
1. Suitability Petitions
10. OTC Drug Labels, Labeling, Marketing and Advertising Issues
1. 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.
1. Beyond those indications, other labeled uses and indications are not permitted.
2. Definitions of the terms “label” and “labeling”
3. Labeling includes the Immediate Container, Outer Packaging, Package Insert, Client Information Sheet, Shipping Label
4. Elements of an OTC Drug compliant label
1. Active Ingredient
2. Use
3. Warnings
4. Inactive Ingredients
5. Purpose
6. Directions
7. Other Information
5. Promotional Materials
1. Brochures, Press Releases, Flyers, Audio and Advertising
2. Written Media, Broadcast Media, Internet Media, Social Media
6. Strategies for Regulatory Compliance
11. FDA Enforcement Actions
1. Noncompliance and Enforcement
1. FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution
1. FDA’s Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy
2. Local, State, and Tribal governments
3. Types of Enforcement Actions
1. Warning Letters and Untitled Letters
2. Seizures
3. Injunctions
4. Monetary Penalties (21 USC §§ 303 and 307)
5. Criminal Prosecution
6. Debarment
4. Park Doctrine – Corporate Official Liability under FDCA
5. Overlapping Agency Jurisdiction – FDA, DOJ, FTC, USDA, and State Agencies

Karl M. Nobert is a food and drug regulatory attorney with the Nobert Group LLC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.