What you Need to Know to Successfully Market and Sell an Over-the-Counter Drug Product in the United States; and Strategic Advice for Avoiding FDA Enforcement Action

Why Should Attend:

This online workshop will provide attendees with a comprehensive review and understanding of the process for designing, developing, manufacturing and selling an OTC Drug Product in the U.S. For purposes of regulatory compliance, the workshop will also focus on FDA’s regulatory requirement covering OTC drug products; and offer strategic recommendations for not only success but also for mitigating the risk of FDA enforcement risk and general liability.

Some of the topics to be covered during this online workshop will include:

• FDA’s requirements for marketing and selling an OTC drug product in the U.S.
• Methods for determining whether a drug product can be marketed and sold as an OTC drug
• The regulatory pathways for commercialization of an OTC drug product
• The OTC Monograph process and Understanding how to Use Them
• FDA’s permitted Rx-to-OTC Switch Process
• How to properly label and market an OTC drug product, and
• Strategies for mitigating regulatory enforcement risks and liability.

Learning objectives:

• Gain a comprehensive understanding of how OTC Drug Products are regulated in the U.S.
• Be able to distinguish between a potential Rx pharmaceutical product and an OTC drug.
• Learn 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.
• Know 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.
• Recognize potential marketing and promotional risks.
• Possess a working knowledge of the Rx-to-OTC Switch Process.

Areas Covered:

• 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:

• 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. He provides regulatory advice and counseling to domestic and international pharmaceutical, OTC and consumer product companies on issues related to the U.S. Food and Drug Administration’s regulation of the manufacture, labeling, distribution, marketing and sale of drugs, dietary supplements, devices and food. He regularly works with companies on labeling and marketing compliance; provides counseling to clients during FDA enforcement proceedings; and supports due diligence efforts related to product line and company acquisitions in the pharmaceutical, OTC drug and dietary supplement sectors.

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. 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. 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.

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. OTC drug products currently represent a huge percentage of all drug products sold in the United States. When properly manufactured and labeled; and used as intended; OTC drug products are safe, effective and can be easily purchased in the market by consumers.

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.

If you can cook and follow a recipe; then you can make an OTC Drug Product with access to the necessary resources and an appropriate facility.

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 OCT 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.

Most OTC drugs available today are marketed and sold as OTC Drug Monograph compliant products. A very, very small percentage of products still come into the market as the subject of an original FDA approved NDA. However, a segment of particular industry growth is coming from reliance on FDA permitted Rx-to-OTC Switch process which allows companies holding FDA approved Prescription (Rx) product to transition to the OTC drug space. One such example includes Prilosec and Pepcid AC. This option is becoming increasingly popular as pharmaceutical companies look for creative ways to extend the overall Product Life Cycle of their hugely profitable Rx drug products.

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