CONFIDENTIAL © 2015 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on...

CONFIDENTIAL © 2015 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form, without the express written consent of the author or presenter. The information on this page is

intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.

Device Labeling, Advertising,and Promotion

IMDMC Reg. 101 June 25, 2015Lynn C. Tyler

CONFIDENTIAL © 2015 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is confidential, proprietary and the property of Barnes & Thornburg LLP, which may not be disseminated or disclosed to any person or entity other than the intended recipient(s), and may not be reproduced, in any form,

without the express written consent of the author or presenter. The information on this page is intended for informational purposes only and shall not be construed as legal advice or a legal opinion of Barnes & Thornburg LLP.

Part One: Regulatory Framework for Product Promotion• “Label” is a:– display of written, printed, or graphic matter upon the

immediate container of any article....

• “Labeling" is: – all labels and other written, printed, or graphic matter

(1) upon any article or any of its containers or wrappers, or (2) accompanying such article.



Definitions• “Accompanying”:

– Is interpreted liberally to mean more than physical association with the product

– Extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, etc., depending on how they are used

– Includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.

– Can also include website content and other information a manufacturer posts online

• But what of a tweet or a post on a discussion board?



What is required?

• FDA specifically requires certain information, prominently displayed (unless exempt): – Established name of the product – Name and place of business of the manufacturer, packer,

or distributor – Net quantity of contents – Adequate directions for use and adequate warnings

• Use means intended use - the objective intent of the persons legally responsible for the labeling of devices

• Label approved by FDA along with device



FDA Regulation of Advertising• Advertising – Not defined in the FD&C Act – FDA likes to treat advertising as labeling

• According to an appellate court decision: "Most, if not all advertising, is labeling.… Congress did not, and we cannot, exclude from the definition printed matter which constitutes advertising.”

– Advertising includes: • Journal and magazine ads • Television or radio commercials • Direct mail or email communications • Certain online promotion

– FDA regulates restricted device advertising and labeling



Fundamental Prohibition

• The term misbranded means: – “False or misleading in any particular” • False generally is understood to mean a statement

that in any material respect is untrue • Misleading is less clear (to whom and how much?)

– Twin goals of:• Safety and effectiveness • Preventing economic fraud



Fundamental Prohibition (continued)• Examples of false labeling include: – Incorrect, inadequate, or incomplete identification – Omitting other required information– Unsubstantiated claims of therapeutic value – Substitution of parts or material – Inaccuracies concerning condition, state, treatment,

size, shape, or style• Examples of misleading labeling include: – Ambiguity, half-truths, and trade puffery – Expressions of opinion or subjective statements – Failure to reveal material facts, consequences that may

result from use, or the existence of difference of opinion



Fundamental Prohibition (continued)• Examples of other objectionable labeling

practices include – Deceptive pictorial matter – Misleading testimonials – Misleading list of parts or components – Use of brand or trade names instead of

“established names”



FTC Regulation of Advertising• FTC has jurisdiction over advertising for a non-

restricted device • FTC applies three requirements – Adequate substantiation – No deception, from the standpoint of the reasonable consumer – Fairness

• Agency influenced by lawyers who focus on consumers and how they are affected



Part Two: Claim Substantiation

• Topics – Generally – Comparative claims – Establishment claims



Claim Substantiation Generally• Refers to the evidence needed to support a claim

regarding some feature or performance of the device – Must support both express and implied claims – In labeling, revolves around the FD&C Act “false and

misleading” language – In advertising, FTC standard requires firm to have a

reasonable basis in objective evidence before the claim is made



FTC Factors for Adequate Substantiation

• Type of product • Type of claim • Benefits of a truthful claim • Cost/feasibility of developing substantiation

for the claim • Consequences of a false claim • Amount of substantiation that experts in

the field believe is reasonable



Comparative Claims• These compare the device to another device • FDA considers them inherently misleading – Requires that such claims be supported by sound

scientific data, usually a rigorous study that directly compares the devices

• FTC does not have that same predisposition, instead favoring useful comparisons – But likewise requires rigorous scientific evidence, again

a study or studies comparing the devices



Establishment Claims

• These are claims that declare or even suggest that a device’s superiority has been scientifically proven

• Both FDA and FTC require the company to have at least the level of evidence stated or implied in the claim – There is also a baseline of support required – Studies must be able to withstand criticism



Part Three: Off-Label Promotion

• Off-Label Use Rules – Basic Intended Use Framework– Definition

• First Amendment Issues



Basic Intended Use Framework

• Under 21 CFR 801.4, the words “intended use” … refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. …



Judging Intended Use1. Words

a. External (e.g. labeling, sales lit., advertising, sales pitches) b. Internal (e.g. business planning, sales force memos, training programs)

2. Actions, for examplea. Design features (i.e. uniquely medical features) b. Distribution (e.g. medical sales and distribution channels) c. Where do your sales people visit?

3. Circumstances (inferences), for examplea. How legitimate are non medical uses b. Actual sales volume



Off-Label Use

• If an intended use is for other than the approved indication: – The lack of approval for the new intended use

makes the device “adulterated” – The lack of adequate labeling makes the device

“misbranded”



First Amendment

• FDA’s authority to regulate off-label promotion has been limited by the courts – any such regulation must be narrowly tailored to achieve a legitimate FDA purpose

• Recent important cases:– Sorrell v. IMS Health (2011) (Vermont statute

prohibiting the sale of prescriber information for pharmaceutical “detailing” was unconstitutional )

– U.S. v. Caronia (2012)(government cannot prosecute drug firms and their reps for speech promoting the lawful, off-label use of an FDA-approved drug)



Impact of the Litigation• FDA cannot infringe on the right of medical device

companies to promote their products if other, less restrictive measures can achieve FDA's objectives, such as:– Disclaimers and warning labels – Disclosures – Limitations on non-speech related activity – Narrowing of speech restrictions

• But, don’t want to go here because of huge risks, including criminal penalties and debarment



Part Four: Marketing in a Regulated Environment• Different Stages of Promotion • General Risk Areas

– Unsolicited Requests – Trade shows– Scientific meetings– Websites – Social media – Distributing reprints on risk and unapproved uses– SEC disclosure and investor communications

• Good Promotional Practices



Basic Rules For Development Stage Communication• Thou Shalt Not Discuss Beyond the Anticipated Approved Label

– Whatever the company says now about its upcoming product will create an impression in the minds of the customers who may ultimately be asked to purchase that product.

– If the company describes uses that do not ultimately get approved, the company will be creating an off-label promotion situation once the product is introduced into commercial distribution.

• Thou Shalt Tell the Truth – Both FDA and FTC would have difficulty proceeding against the company

for statements made in advance of any product being placed in commercial distribution. (But other laws may still be relevant.)

– However, once the opportunity to acquire the product exists, any prior statements made would be evaluated for their truthfulness. Being truthful means, among other things, the statements made are adequately supported by valid scientific evidence at the time they are made.



Investigational Device Labeling Rules• Promotion and commercialization of

devices subject to an IDE is prohibited – Promotion of clinical trial results (needs to be

bona fide scientific exchange) • Tone • Context

– Disclosure of commercial price – Taking or being prepared to take orders – Prolonging the investigation



Unsolicited Requests re: off-label uses• Not result of action taken by firm that, even indirectly, prompts

request for information about off-label use• Public request

– Respond if at all only when firm’s product is named in the request– Limit response to contact information for firm’s medical or scientific department

(not sales)– Do not include any information about off-label use

• Private request– Respond only to person making request– Answer only specific question asked (if broad ?, narrow it first)– Truthful, non-misleading, accurate, balanced (benefits and risks)– Response should be scientific in nature, not promotional– Response generated by scientific or medical personnel, not sales or marketing– Response should include approved label and other information from Guidance– Maintain records about response



Best Practices: Trade Shows

• Train marketing personnel extensively in permitted disclosures

• Consider having clinical personnel present to respond to questions that are off-label

• Maintain a separate space for international uses

• Control disclosures regarding pending 510(k)s



Special Rules: Trade Shows• Special Rules—510(k) Pending – For 510(k) pending devices, special accommodation to

account for infrequent trade shows – Show demo model, with conspicuous statement that

not cleared, 510(k) pending – No performance claims – Can explain intended use and existence of basic

features – Can collect business leads – But do not take orders, or be prepared to take orders,

that might result in contracts of sale for the device unless limited to research or investigational use (e.g., no discussion of commercial price)



Scientific Meetings – Two Types

• “Controlled” – speakers under the control of the sponsor (e.g., employees, consultants) – Investigator meetings – Speaker training – Trade show booths

• “Supported” - speakers are not under the sponsor’s control but sponsor provides support for the program– Sponsored CME



Meetings – Controlled Communications

• Regulated as promotional material• Remarks should: – Be consistent with intended use – Conform to rules applicable to unsolicited requests

• Also consider rules applicable to:– Dissemination of written materials – Appropriate locations – Interactions with healthcare professionals – Speaker agreements



Meetings – Supported Communications• Unregulated scientific exchange, unless sponsor is in a

position to influence the presentation of information about its products

• In determining independence, FDA will consider: – Sponsor's control over content and speakers – Meaningful disclosure of sponsor support, relationships with

speakers, regulatory status of any unapproved uses discussed – Focus of the program (e.g., on a single product or single

company’s products when alternatives are available) – Relationship between provider and sponsor – Etc.



Risks in Interactions with Physicians

• Government enforcement risks arise in the context of: – Business courtesies

• Ensure sales personnel follow applicable guidance with respect to gifts, meals, and entertainment

– Consulting arrangements • Consulting arrangements must be for necessary services pursuant to

written agreements in compliance with regulatory requirements – Research grants

• Grants should be administered outside marketing function, based on objective criteria

– Educational activities & meetings • Sponsored meetings must take place in locations conducive to

educational activities, without providing entertainment and with only modest meals and accommodations



Websites• Who regulates medical device website content?

– FTC and FDA • Is a website labeling or advertising?

– “FDA considers written, printed, or graphic material placed on a manufacturer’s or own label distributor’s Internet website to be labeling.”

– “We suggest that you review your current labeling, including … any internet advertising ….”

• FDA uses conduct prohibited in any medium as a basis of enforcement actions related to websites – New intended use – Promotion of investigational devices



Best Practices: Websites

• Monitor linked sites for off-label/ unapproved information – If you link to it directly, you own it– Provide notice that viewer is leaving your site – Observe the “two click” rule for off-label

information – Avoid links to chat rooms or sites known to

discuss off-label use of the product



Social Media Guidance

• Generally, if you cannot present full benefit and risk within the character space limits, then you should not use that outlet for advertising and promotion



Social media guidance

• Exception: “A concise disclosure of specific risk information may be presented together with benefit information within the confines of character-space-limited Internet/social media platforms if supplemented by a prominent reference to the presence and location elsewhere of a more complete discussion of the risks associated with the product.”



Social media – Part Deux (drugs) • Guidance defines “interactive promotional media” as including “modern

tools and technologies that often allow for real-time communications and interactions (e.g., blogs, microblogs, social networking sites, online communities, and live podcasts).”

• In general, firms are only responsible for content they control, even if financially sponsor a website

• Although the FD&C Act requires drug firms to submit copies of promotional materials at the time of their initial dissemination, the draft Guidance states that the FDA will exercise enforcement discretion if the firms submit monthly updates of their promotional material in these types of interactive media



Guidance on distributing scientific publications on risk (drugs)• FDA will not object to the distribution of new

risk information that rebuts, mitigates, or refines risk information in the approved labeling, under certain conditions



Distributing risk information

• DATA SOURCE – The study or analysis should meet accepted design and

other methodologic standards – The study or analysis should also be at least as persuasive

as the data sources that underlie the existing risk assessment

– The conclusions should be a fair characterization of all relevant safety information

– The study or analysis should be published in an independent, peer-reviewed journal



Distributing risk information

• DISTRIBUTION– Need cover sheet disclosing: • The study design, critical findings, and significant

methodological or other limitations of the study• That the information is not consistent with the

approved labeling • That FDA has not reviewed the data • Any financial interests or affiliations between the study

author(s) and the firm



Distributing new risk information (cont’d)– The reprint or digital copy should be accompanied by the

approved labeling for the product. – The reprint or digital copy, when distributed, should be

separate from any promotional material. – Any statements made by a representative of the firm to a

recipient concerning the reprint should be consistent with its content and the information in the disclosure cover sheet



Guidance - Distribution of Scientific Publications on Unapproved Uses

• Applies to scientific journal articles, scientific or medical reference texts, and clinical practice guidelines (CPGs)

• Establishes a “safe harbor” - as long as firms distribute scientific or medical publications as recommended in the draft guidance, FDA states that it will not use such distribution as evidence of the manufacturer’s intent that the product be used for an unapproved new use (i.e., off-label promotion)



SEC Disclosure Requirements• SEC’s requirement that companies disclose

material information to the investment community, including both positive and negative results of clinical trials, is sometimes inconsistent with FDA’s limitations on disclosure – Clash of pro-speech policy with FDA’s speech

restrictions • SEC has brought enforcement actions against

companies for failure to disclose important information about products in clinical trials



Investor Communications Regarding Investigational Uses• Labeling regulations apply, unless disclosure can be

classified as purely business or a scientific exchange • Pre-approval off-label information, including study

announcements, will be tolerated by FDA if segregated in the investor or news section of a website and/or distributed to the press concurrently with a newsworthy event

• Must avoid-- – Promotional tone – Claims re: safety or effectiveness – Redistribution – Undue prolonging



Good Promotional Practices

• Many leading companies are developing their own GPPs and GRPs

• Approval processes• Essentially a risk management tool—sets

the company’s preferred path forward in a gray area

• Looked upon favorably by regulators if done well

• Become the basis for training and auditing



Part Five: Hypothetical

• Neuro– Infant Stroke Stop – New marketing program (cardiac patients,

comparative claims)

• Product Handling• Patient Mobility– All cardiac and COPD patients



Questions?

Lynn C. [email protected](317) 231-7392

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