1 FDA DRAFT GUIDANCE FOR INDUSTRY REVISED Stuart E Coleman Promotional Review and Regulatory March 30 th, 2015

Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs (Feb 2015) Overview and Recommendation 2

 Historical Perspective – original Draft Guidance  Summary of the February 2015 Revised Draft Guidance  Guidance objectives  Why has it changed?  What has changed?  Case Summary Example (Lunesta)  Recommendation of Point of View (POV) for Hill Holliday 3

FDA Guidance Summary (January 2004) Historical Perspective –In January 2004, the FDA came out with a Draft Guidance on Patient Labeling –In the approved FDA Patient Label, the Guidance states: FDA-approved patient labeling does not address each specific risk included in the FDA-approved professional labeling. Instead, FDA-approved patient labeling communicates the most important information patients need to use the product appropriately, and it focuses on product’s most serious risks and its less serious, but most frequently occurring, adverse reaction. –The Guidance further states that the Label can be reprinted as it was approved for the Professional Label: Contraindications: all; Warnings: all; Precautions: the major precautions, including any that describe serious adverse drug experiences(as defined in 21 CFR (a) & (a)) or steps to be taken to avoid such experience Adverse Reactions: the 3-5 most common nonserious adverse reactions most likely to affect Patient's quality of life or compliance with drug therapy. 4

Revised Draft Guidance 2015 The FDA now believes that the traditional approach that has been used for Consumer promotional labels and advertising are no longer as useful since the consumer for the most part lacks the technical skill and background to understand the vast amount of the information in the PI Note: The revised guidance is in draft form and comments are due to the FDA by 5/11/2015 which was 90 days from the release of the FDA’s Proposed changes. 5

Revised Draft Guidance 2015 Objective –To provide recommendations on the disclosure of risk information in prescription drug product advertisements and promotional labeling in print media directed toward consumers –The brief summary requirement and the requirement that adequate directions for use be included with promotional labeling. The recommendations describe an alternative disclosure approach that FDA refers to as a consumer brief summary. –Note - this revised draft guidance does not focus on the presentation of risk information in the main body of promotional labeling or advertisements and does not apply to promotional materials directed toward health care professionals. –This revised draft guidance revises the draft guidance entitled Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (issued January 2004). 6

Revised Draft Guidance 2015 Why change? –This revised draft guidance responds to stakeholder requests for specific guidance on the disclosure of risk information to consumers and incorporates recent social science research results (Aikin, O’Donoghue, et al. 2011). –Consumer-directed print advertisements for prescription drugs frequently use the “traditional approach or format”, which utilizes the full FDA-approved package insert (PI) –The FDA believes the “traditional” approaches are not optimal for consumer- directed prescription drug print advertisements and promotional labeling. Consumers lack the technical background to understand some of the information as described in the PI –Information may be of limited use to consumers (e.g., clinical pharmacology) 7

Revised Draft Guidance 2015 What are the Changes? –This revised draft guidance recommends alternative approaches firms may use to develop content that can be used to fulfill both the brief summary requirement for consumer-directed prescription drug print advertisements and the requirements in (d) in consumer-directed prescription drug print promotional labeling pieces –Draft guidance provides suggested research-tested formats for this information. –Firms may use alternative approaches if these approaches satisfy the requirements of the statute and regulations. 8

FDA’s Recommendations CONSUMER LANGUAGE & READABILITY –The FDA “strongly encourages” the language below as guidance for consumer labeling: ProfessionalConsumer ContraindicationsDo not use if you have… Who should not use… IndicationWhat is [drug name] Cephalalgia Migraine SyncopeFainting 9

FDA’s Recommendations CONSUMER LANGUAGE & READABILITY –Brief summary should be presented visually in a manner designed for ease of use by consumers. –Use elements in the main body of the ad – like logos and approved branded colors. –Font size and style should be selected and designed for readability –Double space and indentations for white space –Arranging information in text boxes (using borders and headings) –Using other types of attention drawing symbols and such as bullets, capitalizations and consumer friendly words and phrases 10

FDA’s Recommendations CONTENT –FDA suggests that the brief summary should provide clinically significant information on the most serious and the most common risks associated with the product and omit less pertinent information –As a starting point, the FDA suggests that an FDA-approved patient label and Medication Guides, if available for the drug at issue, may be an appropriate starting point to determine which risks should be included in the consumer brief summary –(The client will know which AE’s and which common risks that they will want to include) 11

FDA’s Recommendations CONTENT –Creating the Consumer Brief Summary and should include: –Medication Guides if available –Information from the Highlights Section –Should be placed in order of severity such as, Boxed Warning, Contraindication, Warnings and Precautions –Certain information regarding Warnings and Precautions the most clinically significant information from the Warnings and Precautions section(s) of the PI information that would affect a decision to prescribe or take a drug; monitoring or laboratory tests that may be needed; special precautions not set forth in other parts of the PI measures that can be taken to prevent or mitigate harm. 12

FDA’s Recommendations CONTENT –Creating the Consumer Brief Summary and should include: (cont.) Adverse Events (AE’s) Most occurring If a product has more than one indication, the most common Adverse Reactions for each indication being promoted should be included, if included in the PI Other serious AE’s that lead to discontinuation or dosage adjustment Any debilitating, life threatening, or irreversible effects or risks May also include any monitoring or testing during treatment Special populations (children, minorities, women, etc.) 13

FDA’s Recommendations CONTENT –Creating the Brief Summary Does not need to include: Dosage How it is administered How it is supplied Clinical Pharmacology Specific Directions How long it takes to work 14

FDA’s Recommendations CONTENT –Additional comprehensive information recommended by the FDA Since not all info will be included on the label, the FDA has recommended the following formats and language The risk information provided here is not comprehensive. To learn more, about [drug name] talk with your health care provider or pharmacist. The FDA- approved product labeling can be found at or DRUG This information is not comprehensive. –How to get more information: –Talk to your health care provider or pharmacist 325 –Visit to obtain the FDA-approved product labeling –Call DRUG 15

FDA’s Recommendations FORMAT –The FDA has suggested two formats: –Drug Facts Box which the information could appear as it does on an OTC Drug Facts Box with standardized headings: Who Uses Do not use if you …. Warnings Ask a health care provider before use When using this product you may have 16

FDA’s Recommendations FORMAT –The FDA has suggested two formats: –A Question and Answer (Q&A) format simulates a dialogue using personal pronouns, thus increasing consumer interest in, and comprehension of, the information. What is drug used for?ANS When should I not take drug?ANS What should I tell my HCP?ANS What are the side effects?ANS Are there other meds that might interact? ANS 17

LUNESTA Label* BOX Q & A Provides the What, Who, the clinically significant things to monitor and for and grouped it as “abnormal behavior” They move a step further with Biometrics and give the clinical data from their pivotal trial that shows the risk/benefit profile. The last paragraph at the bottom gives the information of how long the drug has been used and also gives the information that “ as with all new drugs, not enough patients have taken to show the full safety profile” *Please note – The LUNESTA Label shown is a “mock” up taken from PHARMA NETWORK ONLINE

FDA’s Recommendations The FDA will, at times, make “suggestions” and the occasional “recommendation The following uses rather strong language and therefore should really be adhered to from a marketing/advertising agency standpoint. FDA strongly recommends against the use of the traditional approach to fulfill the brief summary requirement, an approach in which risk related sections of the PI are presented verbatim, often in small font, technical language that is difficult for consumers to comprehend 19

Recommendation for Hill Holliday’s Point of View 20 Hill Holiday will recommend one of the two proposed formats in this Guidance based upon: Type of product Type of information to convey Volume of information to convey Type of media being used to display the summary “Hill Holiday will provide clients with advice and comments according to its best understanding of the FDA Guidance and applicable regulations. As with all marketing and labeling materials, final approval is the sole responsibility of the client.