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2 Looking to market your product in the US? How to optimize brand value to achieve this. Craig Boucher Sales & Marketing Director Lynn Donaldson CEO

3 About Us Strategic support and consulting solutions for Biotech/Biopharma companies to maximize the value of their late-stage discovery and early clinical portfolios Strategic partners:

4 Objectives Introduction to:» US regulatory pathway for OTC or none prescription drug products» Overview of the OTC monograph system» Requirements for all OTC drug products For more information go to -

5 What is an OTC drug? The term drug is a legal one. As described by the Federal Food Drug, and Cosmetics Act:» A drug is an article intended for use in the diagnosis, cure, treatment, or prevention of disease and/or an article (other than food) intended to affect the structure and function of the human body and/or an article intended for use as a component of such an article

6 What do we mean by Intended Use? Your products intended use(s) is very important.» It can affect how your product will be regulated and whether it will be regulated as a drug» It can render your product a drug, independent of its ingredients, and regardless of whether or not you consider your product a drug What does the FDA say?» Intended use is the objective intent of the persons legally responsible for the labelling of drugs. The intent is determined by such person s expressions or may be shown by the circumstances surrounding the distribution of the article

7 What is Objective Intent? The FDA determines your product s objective intent by:» Labelling claims» Advertising matter» Oral or written statements by manufacturers, sponsors or their representatives NOTE: Claims on your website can and are used by the FDA in determining intended use.

8 What is an OTC drug?» An OTC drug is considered safe and effective for use by the general public without a prescriber's authorization.» Necessary characteristics for OTC drugs include: 1. The product has an acceptable safety margin 2. The product has low misuses and abuse potential under conditions of widespread availability 3. A healthcare practitioner is not needed for the safe and effective use of the product 4. The product has adequate labeling Consumers must be able to self-diagnose, self-select the medication, self-treat, and self-manage the condition for which the OTC drug is intended.

9 OTC vs R x» An important regulatory distinction between OTC and prescription drug R x involves the requirements for adequate directions for use.» All drugs must have labelling that bears adequate directions for use.» Prescription drugs require the intervention of a licensed healthcare professional.

10 Which agencies do you need to interact in the USA?

11 OTC Drug Monograph» An OTC drug monograph is a kind of rule book of conditions for each therapeutic category covering acceptable ingredients, uses (indication), doses, formulations, labeling, testing.» A drug marketed that is consistent with the conditions set forth under a final monograph and all other general applicable OTC requirements is considered generally recognized as safe and effective for the uses set forth under the monograph.

12 OTC vs NDA process» The OTC monograph system is a regulatory pathway for bringing and OTC drug product to market without FDA approval» The product must be marketed consistently with the requirements of the OTC monograph system so that it is considered GRASE» If not marketed in accordance with the requirements of the OTC monograph system, a product is not GRASE and will likely be considered a new drug.» All new drugs require FDA approval before marketing. GRASE = Generally Recognized as Safe and Effective

13 NDA» The alternative regulatory option for legally marketing an OTC drug is the FDA New Drug Application (NDA) process. Though the vast majority of currently marketed OTC drugs are under the OTC Drug Review, there are many OTC drugs individually approved through NDAs

14 NDA vs OTC Monograph NDA Approval process Pre-market approval FDA review and approves formulation and labeling prior to marketing. Confidential filing Drug-product specific May require a user fee Potential for marketing exclusivity FDA review timelines May require clinical studies, including studies on label compprehension and actual use Approved labeling is unique to the drug Approved NDA is your "license" to market Trade name reviewed prior to marketing OTC Monograph Process No pre-market approval FDA sets forth specific conditions for GRASE, or in the case of a developing monograph, sets forth conditions that allow for continued marketing pending a final monograph. Oversight occurs on a post-marketing basis. Public process Active ingredient-specific and evaluated by OTC drug category No user fees No marketing exclusivity Manufacturers responsible for ensuring compliant product with no FDA-mandated review (either pre- or post-market) Generally does not require clinical studies. Label comprehension and actual use studies are not required for ingredients already covered by a final or tentative final monograph. Labeling is defined by the monograph. Once marketed, FDA can review the complete labeling at any time to determine whether it is truthful or misleading. Final monograph is open to anyone No review of trade name prior to marketing. Once marketed, FDA can review the trade name at any time.

15 OTC requirements» The two regulatory pathways for bringing an over-thecounter (OTC) drug to market, the New Drug Application (NDA) process and OTC Monograph Process, are quite different, and there are certain requirements that apply to all OTC products regardless of the regulatory pathway used

16 Pathway to success

17 Does my product fall under the OTC Monograph? Factors Factor #1 Factor #2 Factor #3 Factor #4 Factor #5 Factor #6 Description of Factors Start by checking to see if your active ingredients are "non monographed" by final rule (i.e., conditions that by regulation cannot be marketed under a monograph and instead require an application). Identify any relevant monographs that may address your product based on your product's intended use(s) and active ingredient(s). Check to see if your product meets the conditions set forth under a final monograph. Determine whether your product can be marketed under the OTC Drug Review if the relevant monograph is not finalized (tentative final monograph or other rulemaking). Make sure your product's inactive ingredients are safe and suitable. Amending a Monograph

18 Resources Here are some additional resources and links:» CDER Small Business Assistance Web page: nessassistance/» Over-the-Counter Drug Review Process Web page: nessassistance/ucm htm» FAQs: nessassistance/ucm htm

19 Examples Product EU Classification US Classification Product A (Suppository) Medical Device OTC Monograph Product B (Antacid) OTC R x Product C (Antiviral cream) OTC R x Product EU Classification US Classification OTC Rx Product A Mebendazole (Antihelminthics) Product B Levonorgastrel (Oral Contraceptive/Sex hormone) Product C Metoclopromide (Antiemetic, anti migraine) Belgium, Ireland, Switzerland Belgium, Switzerland, Ireland, Denmark Austria, Denmark, Bulgaria, Czeck Republic, Germany, Denmark, Estonia, Spain, France, Hungary, Croatia, Italy Germany, Hungary, Italy R x only OTC only Italy All other EU countries R x only