The Regulations of OTC Drugs
The U.S. Food and Drug Administration’s (“FDA”) is responsible for the regulation and oversight of the U.S. OTC drug market. Congress has granted FDA regulatory authority over the formulation, manufacturing, labeling, marketing and promotion; and import / export of OTC drug products into the U.S. Under this current regulatory regime, there are 3 pathways that a company may follow to enter the OTC drug market including (a) following an appropriate Drug Monograph; (b) with an Agency approved New Drug Application (“NDA”); or (c) via the currently popular Rx-to-OTC Switch Process.
This course on FDA regulation of OTC drug products is intended to provide attendees with the knowledge and skills needed to develop and produce an OTC Drug Product for marketing and sale in the U.S. Attendees will gain an understanding of :
Various available options for producing and selling an OTC drug product,
U.S. Food and Drug Administration’s (“FDA”) regulation of OTC drug products,
Strategic recommendations for mitigating the risk of enforcement action in the future.
Participants who attend this course on FDA regulation of OTC drugs 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
DAY 01(8:30 AM - 4:30 PM)
Registration Process - (8:30 am till 9:00 am)
Session Start Time: 9:00 AM
Lecture 1: Overview of Drug Regulation in the United States
Role and function of FDA generally
FDA’s purpose and mission
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)
Structure of FDA: Specifics of CDER
CDER’s organization (discuss divisions and duties within each office)
Introduction to the FDCA, Regulations, and Guidance Documents
Overview of FDCA and regulations
Introduction to FDA guidance
Lecture 2: OTC drugs v. Rx Drugs
Differences between the two
How to distinguish
Lecture 3: History of Regulation of OTC Drugs in the US
Statutory and Regulatory Authority for OTC Drugs
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.
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).
Lecture 4: OTC Drug Review Process
New Drug Approval Process
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.
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”).
Lecture 5: OTC Drug Monographs
Notice of Proposed Monograph
Proposed Final Monograph
Final OTC monograph establishes the acceptable:
concentration of the active ingredients
directions for use
Marketing the OTC drug product when the Monograph is not final
DAY 02(8:30 AM - 4:30 PM)
Lecture 7: Status of specific OTC Monographs, their included Regulatory Requirements and Strategies for Commercialization
Cold & Cough
Other Monographs as appropriate
Lecture 8: OTC Drug Ingredients
Substantiating the safety and efficacy of a proposed new ingredient
Showing why an Ingredient should be included in the Monograph
The concept of GRAS
Lecture 9: Marketing a drug product that deviates from a final monograph
Lecture 10: 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
Brochures, Press Releases, Flyers, Audio and Advertising
Written Media, Broadcast Media, Internet Media, Social Media
Strategies for Regulatory Compliance
Lecture 11: 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
Monetary Penalties (21 USC §§ 303 and 307)
Park Doctrine – Corporate Official Liability under FDCA
Overlapping Agency Jurisdiction – FDA, DOJ, FTC, USDA, and State Agencies