Course Description:

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.

Learning Objectives:

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

Facts about OTC Drugs:

  • Market studies suggest that there are currently over 300,000 OTC Drugs being marketed and sold in the U.S. today and that number is growing daily.
  • This amounts to almost 60% of the total U.S. drug market (by purchases) and this number is expected to grow in the future.
  • Based on these predictions alone, this is a profitable market and growth potential that drug and health product companies cannot afford to ignore.
  • Go into any CVS Retail Pharmacy, Wal-Mart, Meijer Grocery Story, Rite Aid Retail Pharmacy or Target in the United States; and you are guaranteed to find store shelves lined with hundreds or even thousands of different OTC Drug products.

Event Tags: OTC Drug Products, FDA regulations: formulation, manufacturing, labeling, marketing and promotion, import / export, New Drug Application (“NDA”), Rx-to-OTC Switch Process, GRAS/E, CFSAN, CDER, CBER, CDRH, CVM, ORA, Seizures, Injunctions, 21 USC §§ 303 and 307, FDA, DOJ, FTC, USDA, and State Agencies

Who will Benefit:

This course is designed for people tasked with formulation, manufacturing, labeling, marketing and promotion; and import / export of OTC drug products; and responsible for overseeing a company’s regulatory strategies. The following personnel will find this session valuable:

  • 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
  • Consultants, Inspectors and cGMP Experts

Topic Background:

Have a Headache? Back from lunch and now experiencing mild occasional Heart Burn? Suffer from Allergies? Been stuck in bed with a Cough, Sore Throat, Nasal Congestion and a Fever you just can’t shake? Pitched the tent in Poison Ivy on last weekend’s family camping trip by mistake? Use Deodorant? Anyone who has ever has suffered from these or similar occasional symptoms and conditions has likely relied upon an Over-the-Counter Drug Product or “OTC Drug” to feel better.

Over-the-Counter Drug Products or “OTC Drugs” include many of the well-known products that we use to treat or control the symptoms of occasional and moderate health conditions. Available without a prescription and for purchase directly off-the-shelf, OTC drug products currently represent nearly 60% of all drug products sold in the United States. Some of the most recognized OTC drug products include ibuprofen tablets, anti-itch creams, nasal decongestant sprays, cough syrups, antacids, allergy medicines and topical pain relievers. Available without a prescription and bought right off the store shelf, OTC drugs are safe and effective when properly labeled and used as intended.

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8.30 AM - 9.00 AM

Session Start Time: 9.00 AM
  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

  1. 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.
  2. 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
  3. Marketing a drug product that deviates from a final monograph
    1. Suitability Petitions
  4. 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
  5. 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

Meet Your Instructor

Karl M. Nobert
Food and Drug Regulatory Attorney, The Nobert Group LLC

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.

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Local Attractions

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The Miami Science Museum is a great learning place. The museum itself also contains the Space-Transit Planetarium, Weintraub Observatory and a wildlife center. Those interested in galaxies, stars, planets and the intricate workings of the universe can quench their thirst for knowledge here.

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