legal considerations: industry use of social media · with respect to consequences of use ›...

©2011 Goodwin Procter LLP

Legal Considerations: Industry Use of Social Media

Stephanie PhilbinMassMEDICWaltham, MAMay 13, 2011

2Goodwin Procter LLP

Overview

� FDA regulation of device advertising and promotion� Internet promotion� Social media – Facebook, Twitter, YouTube, etc.


FDA regulation of device advertising and promotion

� FDA’s scope of legal authority = regulate labeling for all devices; advertising for “restricted devices” only› Device may be declared restricted by regulation under FDCA § 520(e) (e.g.,

hearing aids, analyte specific reagents) or as a condition of PMA approval� Over 95% of devices are not restricted � Device is misbranded if it fails to meet advertising and other requirements

for restricted devices, FDCA § 502(q) (false and misleading in any particular), (r) (brief statement of intended uses and relevant warnings, precautions, side effects, and contraindications)

› FTC regulates all device advertising

� However, FDA attempts to regulate all device advertising of off-label usethrough the broad definition of labeling and the FDCA’s misbranding and adulteration provisions



� Key definitions� Labeling (FDCA § 201(m))

› All labels and any other written or graphic matter upon any articles or any of its containers or wrappers, or accompanying such article

› “Accompanying” – very broad can be anything written disseminated by the manufacturer that supplements or explains the product, Kordel v. United States, 335 U.S. 345 (1948)

� Intended use (21 CFR § 801.4)› The objective intent of the persons legally responsible for the labeling of devices› May be demonstrated by labeling claims, advertising, oral or written statements,

or actual use� Statements by sales representatives are evidence of intended use

• Thus, sales reps should not initiate discussion of off-label use and if asked, identify as off-label use and answer truthfully without elaboration



� Misbranding› Labeling is false or misleading in any particular – e.g., omissions, ambiguities,

literal truths creating false impressions, FDCA § 502(a)� See FDCA § 201(n) for misleading – includes failure to reveal material facts

with respect to consequences of use› Labeling fails to contain adequate directions for use (unless exempt, i.e., Rx),

FDCA § 502(f)(1)� Directions under which a lay person can use a device safely and for the

purposes for which it is intended� Through this provision, FDA indirectly regulates non-restricted device

advertising for off-label promotion -> asserts promoted device lacks adequate DFU

› No 510(k) for new intended use, FDCA § 502(o)� Adulteration

› New intended use also renders device adulterated under FDCA § 501(f)(1)(B) (automatic classification into class III, PMA status and no approval or exemption)

� In sum, an advertising claim can give rise to a labeling obligation and a premarket submission



� Investigational devices› No promotion or test marketing of investigational devices, 21 CFR § 812.7

� No safety or effectiveness (or comparative) claims• Adulterated because of failure to comply with IDE requirements, FDCA § 501(i)• FDA also may assert

›Misbranded because labeling is false or misleading, FDCA § 502(a); ›Adulterated because it is a Class III device without an approved PMA or IDE,

FDCA § 501(f)(1)(B); ›Misbranded because no 510(k) was submitted, FDCA § 502(o)

� “This section ensures that investigational devices are not advertised before their claims are established, helps prevent such devices from being distributed too widely, and prevents an IDE from serving as a subterfuge for unapproved marketing.” 45 Fed. Reg. at 3741

� Example of FDA asserting a website represents an investigational device as safe and effective - 2/5/97 Warning Letter to Gynecare, Inc. for its Uterine Balloon Therapy system

� Disclaimer will not protect violative claim – 5/12/98 Warning Letter to LaserSight Technologies, Inc. for its website

• FDA: “a statement that the device is for use in approved investigational studies only is totally lacking”



� Off-label promotion›Off-label use = Any uncleared or unapproved use, e.g., disease or

condition, population, or method/schedule of use›Post Washington Legal Foundation case

� Dissemination to medical professionals of peer-reviewed articles that are truthful and not misleading will likely not be subject to enforcement action if (1) the manufacturer’s interest in the productand (2) the fact that the product is unapproved for the use being discussed are disclosed

� See FDA’s Guidance (Jan. 2009) on “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices”

� Can provide a peer reviewed journal article upon request from a health care professional


Internet promotion

� CDRH views Internet statements as subject to same requirements as other product-related promotional statements›Promotional information on home pages regulated like labeling

� Messages in print/broadcast media more likely to be regulated asadvertising

›Significant number of CDRH promotion-related warning letters since beginning of 2000 included off-label violations alleged to be made on websites or via links from websites

� Website review is one of the primary means by which FDA investigates and regulates promotional claims


Internet promotion

� Discussion of unapproved products/uses›You are responsible for statements in third party articles and

testimonials on your website or made through a link� E.g., 11/19/99 Warning Letter to Cellulite Reduction of New York –

ESI therapeutic massager, cleared for temporarily reducing appearance of cellulite

• FDA alleged company was making unlawful claims on its website (reduces cellulite, reshapes the body, etc.) and through links to several sites containing testimonials that discussed unapproved uses (e.g., weight loss, reduces cellulite permanently)

• FDA said device is adulterated under FDCA § 501(f)(1)(B) (no PMA for such uses) and misbranded under FDCA § 502(o) (no 510(k) for such uses)


Internet promotion

� E.g., 7/28/10 Untitled Letter to Life Recovery Systems HD, LLC –ThermoSuit cleared for temperature reduction in patients where clinically indicated, e.g., in hyperthermic patients, and in monitoring patient temperatures

• Website had links to several advertisements from peer-reviewed journals, articles, and video presentations that promote the device for new intended uses, e.g., for the prevention of permanent tissue and neurological damage, for increasing survival rate in cardiac arrest patients, and for limiting damage to the brain and tissues after cardiac arrest

›Links connected to King’s Daughters Medical Center, Resuscitation (journal), Good Housekeeping

• FDA alleged device is adulterated under FDCA § 501(f)(1)(B) (no PMA for such uses) and misbranded under FDCA § 502(o) (no 510(k) for such uses)


Internet promotion

› There should be separate web pages for U.S. and international products with different indications; disclaimers are not effective� E.g., 7/24/00 Warning Letter to Datascope – VasoSeal vascular hemostasis

device (FDA approved)• FDA alleged company made claims on company website and in

promotional letters specifying a rate of major complications that was less than that identified in the approved labeling

• FDA said such claims render the device adulterated under FDCA §501(f)(1)(B) (no approved PMA supplement for labeling change affecting safety of device) and misbranded under FDCA § 502(a) (labeling is false or misleading)

• FDA also noted that a section of the website includes both U.S. and European indications with disclaimer “Not applicable to U.S. market”

• FDA stated that such disclaimers are not effective; there should be separate web pages for U.S. and international products, although they may be accessed through icons on a single home web page


Internet promotion

›Keep investor materials separate� E.g., 4/14/00 Warning Letter to LaserSight Technologies, Inc.

• Laser was PMA approved to perform photorefractive keratectomy (PRK) for the reduction or elimination of mild to moderate myopia; FDA asserts promotional materials included unapproved uses

• Various press releases under the ‘Investor Relations’ subsite discuss international testing/uses of the laser and/or uses not approved in the U.S.

• FDA: “We caution you that while it is acceptable to include this information for dissemination to investors, we would object if the information were promoted in press releases to the general public, or if the general readers of your internet site were specifically directed to the Investor site.”


Social media – Facebook, Twitter, YouTube, etc.

� FDA uses social media›“We, like everyone else, are using and exploring the use of social media

in recalls and in other situations to get information out. We’ve just scratched the surface on that, but clearly, that’s a way to reach the elements of the population that have access to those media.” Remarks presented by Michael Taylor, Deputy Cmmr. for Foods (March 24, 2010)

›CDRH “Messages on Twitter will include recalls, approvals, other safety information, notices of upcoming meetings, releases of new and updated guidance documents, new web postings, and highlights of the web site and the many tools available to help users comply with regulations and understand and respond to health issues”

›Disclaimer – “Messages, followers, and those we are following do not in any way imply endorsement of any device, product or organization.”

� After Nov. 2009 FDA meeting on Internet and social media, still awaiting draft guidance



� Facebook - Untitled letter to Novartis (July 29, 2010)› Division of Drug Marketing, Advertising, and Communications (DDMAC) reviewed

Novartis’ U.S. website for Tasigna, which is “indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive [Ph+] chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib”

› Website contained a “Facebook Share” social media widget that generated Novartis-created information for Tasigna that can be shared with Facebook users (“shared content”)� The healthcare professional and consumer-directed web pages of the U.S.

Tasigna product website each contained a “Facebook Share” widget -> clicking on it takes users to a separate web page with Novartis-created content

� Users can post the shared content on their Facebook profile walls› Shared content is misleading because it fails to communicate any risk info

� Particularly concerning because of Boxed Warning and REMS program� Inclusion of a hyperlink “is insufficient to mitigate the misleading omission of

risk information from these promotional materials”› Misbrands the drug under FDCA § 502(a), (n), and 201(n)



� Facebook – Warning Letter to Organic Ease, Inc. D.B.A. AloeElite (March 30, 2011)›Therapeutic claims on website establish product, AloeElite, is a drug

needing prior approval›Facebook account includes the following claim: “AloeElite is an all-

natural supplement used to treat moderate to severe digestive disorders such as Ulcerative Colitis, Crohn’s disease, IBS, diverticulitis, and a host of other conditions”

›Product is misbranded under FDCA § 502(f)(1) because adequate directions cannot be written so that a layperson can use the product safely for its intended uses



� YouTube – Warning letter to Shire Development Inc. (Sept. 25, 2008)›DDMAC reviewed a website and video testimonial featuring Ty

Pennington posted on youtube.com by Shire for Adderall XR Capsules, indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)

›Both website and video overstate the efficacy; video omits risk information; website broadens the indication by suggesting unapproved uses� In video testimonial, claims “It literally changed my life, and gave me

the confidence to achieve my goals…” -> imply an impact on aspects of a patient’s life that are much broader than those actually impacted by Adderall XR treatment

� Video entirely omits risk information, including contraindications, warnings, precautions, and common AEs associated with the drug

›Misbranding under FDCA § 502(a), (n), and 201(n)



� YouTube – Warning letter to Breast Health Imaging Centers (Jan. 6, 2011)›Telethermographic camera was cleared “for use as an adjunct to other

clinical diagnostic procedures in the diagnosis, quantifying, and screening of differences in skin surface temperature changes”

›CDRH’s Office of Compliance reviewed website and radio spot and found claims device can be used alone to diagnose or screen diseases and conditions, including� Video on website and YouTube entitled “An Alternative to

Mammograms: Thermography…”›Adulterated under FDCA § 501(f)(1)(B) (no PMA or IDE) and

misbranded under FDCA § 502(o) (no 510(k))



� YouTube – Warning letter to 2035, Inc. and QLaser Healing Light LP (March 3, 2011)›Laser was cleared “for providing temporary relief of pain associated with

osteoarthritis of the hand, which has been diagnosed by a physician or other licensed medical professional”

›CDRH’s Office of Compliance reviewed websites and promotional brochures and found off-label claims, including� “There’s just unlimited things that the laser will do from migraines to

asthma to sciatic nerves.” – video on websites and at a YouTube Channel registered to QLaser Healing Light

›Adulterated under FDCA § 501(f)(1)(B) (no PMA or IDE) and misbranded under FDCA § 502(o) (no 510(k))



� Sponsored links – 14 Untitled letters to drug companies (March 2009)›DDMAC reviewed company’s sponsored links on internet search

engines, e.g., Google.com›Sponsored links are misleading because they make representations

about efficacy, but fail to communicate any risk information� “For promotional materials to be truthful and non-misleading, they

must contain risk information in each part as necessary to qualify any claims made about the drug.”

� Sponsored links contained a link to the products’ website – this is insufficient to mitigate the misleading omission of risk information

›Also inadequately communicates drug’s indications, overstates drug’s efficacy, and fails to use the required established name

›Misbranding under FDCA § 502(a), (n), and 201(n)



� Adherence email – Untitled letter to Novartis (April 14, 2010)› DDMAC reviewed a direct-to-consumer (DTC) adherence email for Voltaren Gel,

indicated for the relief of pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands� Not been evaluated for use on the spine, hip, or shoulder; also has a Boxed

Warning as an NSAID› Minimizes risk information, overstates efficacy, and broadens the indications

� Relegated risk information to bottom of email and in extremely small font and in single-spaced paragraph; risk information used complex medical terminology

� Large headline “Keep relieving your OA joint pain* with targeted relief” – full indication under asterisk was in small font; not comparable in prominence to the large headline and would not appear on viewers’ screen at the same time as the headline claim (rather they would have to scroll down in the email to see this context)

› Misbranding under FDCA § 502(a) and (n)



� (Blogs) – Untitled letter to Bayer HealthCare Pharm. (Dec. 30, 2009)›DDMAC reviewed a script (submitted by Bayer) for a live consumer-

directed program for Mirena, levonorgestrel-releasing intrauterine system (5 year contraceptive)� Mirena program is a live presentation designed for a consumer

audience of “busy moms.” Program presented in a consumer’s home or other private setting (e.g., private restaurant party) by a representative from Mom Central (a social networking internet site)and a nurse practitioner (from Bayer)

›Overstates efficacy, presents unsubstantiated claims, minimizes risks, and includes false or misleading presentations

›Misbranding under FDCA § 502(n)›Reuters article (Sept. 3, 2010): bloggers from NY and Ohio wrote about

the parties immediately afterward


FDA enforcement

� FDA becomes aware of misbranding and adulteration violations from:› Competitors*› Customer complaints

� May 2010 - “Bad Ad Program” directed at healthcare professionals for Rx drug marketing; trickle over to devices?

› Significant adverse events*› Inspections› Investigators attending trade shows› Website review*

� FDA enforcement› “It has come to our attention” letters, Untitled Letters, Warning Letters, and meetings with

firms› Civil enforcement: seizure and injunction› Criminal prosecution and fines – misdemeanors and felonies› Administrative civil monetary penalties› Recalls and notifications


Other advertising authority

� Federal Trade Commission (FTC)› FTC Act § 5: Prohibits unfair and deceptive acts or practices in or affecting

commerce› FTC Act § 12: Prohibits false advertisements likely to induce the purchase of

food, drugs, devices or cosmetics› FTC deception standard: Advertising is deceptive if –

� There is an express or implied representation, omission, or practice� Material to the purchase/use decision� That is likely to mislead reasonable person in the target group

› Need adequate substantiation for claims, i.e., “reasonable basis”› See Endorsements and Testimonials Guide

� Lanham Act (15 USC § 1125(a))› Provides a civil remedy for, among other things, misrepresentations regarding

competitors’ products› Deception standard is similar to FTC’s

legal considerations: industry use of social media · with respect to consequences of use ›...

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