An Introduction to FDA's Regulation of Over-the-Counter (OTC) Drug Products

Why Should You Attend:

All OTC drugs are regulated by the U.S. Food and Drug Administration’s (“FDA”) and can enter the market in one of the following ways: (a) by complying with an applicable monograph; (b) as the subject of an FDA approved New Drug Application; or (c) via an FDA approved Rx-to-OTC Switch.

Most of the OTC drugs available today are marketed and sold as OTC monograph drug products. Although still a very, very small percentage of the total number of OTC drug products on the market, the Rx-to-OTC Switch regulatory pathway is becoming increasingly popular for placing OTC drugs on the shelves as companies look for ways to extend the life cycle of their branded prescription products.

This webinar will provide beginners with an introduction to FDA’s regulation of OTC drug products. Some of the topics to be covered in this webinar include:

• Whether a drug product can be marketed and sold as an OTC
• The various pathways for bringing an OTC drug to market
• The OTC Monograph process and the products currently covered by monographs
• Switching an Rx drug product to an OTC
• Rules for labeling and marketing an OTC drug product, and
• Strategies for mitigating potential FDA regulatory risks based on recent Agency enforcement action.

Learning Objectives:

• Gain a basic understanding of FDA's regulation of OTC Drug Products.
• Learn to distinguish between the various regulatory pathways for bringing an OTC drug to market.
• Understand how to use an OTC monograph and the various categories of drugs covered by them.
• Have a working knowledge of the Rx-to-OTC Switch option for bringing an OTC drug to market.
• Be able to identify the primary required elements of an OTC drug label.
• Recognize potential marketing and promotional risks.

Areas Covered in the Webinar:

• FDA's regulation of over-the-counter drug products or OTC drugs.
• Bringing an OTC drug to market under an OTC monograph.
• Where to find FDA's list of existing monographs and identification of the various product categories covered by monographs.
• An introduction to FDA's Rx-to-OTC Switch procedures and the benefits / challenges of pursuing such an option.
• Labeling an OTC drug product.
• Potential FDA enforcement risks.

Who will benefit:

This course will provide valuable information to the following personnel in the pharmaceutical industry:

• Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, State Policy Officials, Investment Analysts, Venture Capitalists.
• OTC, Consumer Product and Drug Companies;  Start-ups, Foreign Drug Manufacturers, Importers; Food and Dietary Supplement manufacturers and distributors exploring new potential product sectors
• Financial analysts and investors watching the pharmaceutical, OTC, consumer product,  life sciences and biotech industries

Instructor Profile:

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. 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.

Topic Background:

Over-the-Counter Drug Products or “OTC Drugs” include many of the well-known products that we regularly see at our local drug and grocery stores. They are available without a prescription from a doctor and can be bought right off-the-shelf at the store. They are safe and effective when a consumer follows the directions on the label and as directed by his/her doctor.

Among others, examples of OTC drug products include Ibuprofen tablets, anti-itch creams, nasal decongestant sprays, cough syrups, antacids, allergy medicines and topical pain relievers.

The U.S. Food and Drug Administration’s (“FDA”) regulates the marketing and sale of OTC drugs in the U.S. Today, most of the OTC drugs available are marketed and sold under an existing OTC monograph or a pre-existing non-prescription drug approval. There are however a number of OTC drugs that have been subject to an “Rx-to-OTC Switch” meaning that the product no longer requires a prescription for purchase.

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