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1 Boston Brussels Chicago Düsseldorf Houston London Los Angeles Miami Milan Munich New York Orange County Paris Rome Silicon Valley Washington, D.C. Strategic alliance with MWE China Law Offices (Shanghai) © 2011 McDermott Will & Emery. The following legal entities are collectively referred to as McDermott Will & Emery, McDermott" or the Firm: McDermott Will & Emery LLP, McDermott Will & Emery AARPI, McDermott Will & Emery Belgium LLP, McDermott Will & Emery Rechtsanwälte Steuerberater LLP, MWE Steuerberatungsgesellschaft mbH, McDermott Will & Emery Studio Legale Associato and McDermott Will & Emery UK LLP. These entities coordinate their activities through service agreements. McDermott has a strategic alliance with MWE China Law Offices, a separate law firm. This communication may be considered attorney advertising. Prior results do not guarantee a similar outcome. Regulation of Medical Products Advertising and Promotion James S. Cohen ACI FDA Boot Camp Master Class September 23, 2011

2 AGENDA Applicable laws, regulations, and standards Enforcement Recent trends Questions

3 Advertising vs. Promotion Advertising – 21 C.F.R. § 202.1(l)(1): Advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communications systems Promotion – Labeling FDCA § 201(m): 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 21 C.F.R. § 202.1(l)(2): Broad interpretation of scope of labeling – Communication with health care providers (HCPs) and consumers – Communication of health care economic information to formulary committees FDCA § 502(a): analysis that identifies, measure, or compares the economic consequences … of the use of a drug to the use of another drug, to another health care intervention, or to no intervention.

4 Key Statutory and Regulatory Provisions Federal Food, Drug & Cosmetic Act (FDCA) – § 301(a) and (d): Prohibits introduction of a misbranded or unapproved drug into interstate commerce – § 201(n): A drug is misbranded if labeling or advertising includes misleading representations or fails to reveal material facts – § 502(f): Drug or device is misbranded unless its labeling bears adequate directions for use and adequate warnings – § 502(n): Drug or device is misbranded unless its advertisement or other printed matter includes a true statement of name and formula and a brief summary of side effects, contraindications, and effectiveness FDA regulations – 21 C.F.R. § (c)(1) and (d)(1): Implements FDCA § 502(f) – 21 C.F.R. § 202.1(e): Interprets FDCA § 502(n) – 21 C.F.R. §§ (b)(3) and (f)(4): Requires submission of initial advertisements and promotional labeling to DDMAC and APLB

5 General Principles Claims must be supported by substantial evidence Claims must not be misleading Advertising and promotional materials must have fair balance Advertising and promotional materials must contain a brief summary of the approved prescribing information Claims must be consistent with FDA-approved labeling; no pre-approval promotion Certain exceptions: – Reminder advertising (but not if combined with help-seeking ad) – Coming soon/institutional promotion – Health care economic information presented to formulary committees: claims supported by competent and reliable scientific evidence

6 FDA Guidance FDA guidance* – Presenting Risk Information in Prescription Drug and Medical Device Promotion (DRAFT – May 2009) – Disclosing Risk Information in Consumer-Directed Print Advertisements: Brief Summary (DRAFT – Feb. 2004) – Help-Seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms (DRAFT – Jan. 2004) – Consumer-Directed Broadcast Advertisements (FINAL – Aug. 1999) – Industry-Supported Scientific and Educational Activities (FINAL – Dec. 1997) Division of Drug Marketing, Advertising, and Communications (DDMAC) information and FAQs: – * Select guidance documents; not exhaustive

7 FDA Guidance on Presentation of Risk Information In addition to specific risk-related statements, FDA evaluates net impression – the message communicated by all elements of the piece as a whole Reasonable consumer standard (consumers vs. HCPs) Factors FDA considers when reviewing risk communications – Consistent use of language for benefits vs. risks; appropriate language for target audience – Use of signals (e.g., headlines) – Framing of risk information – Hierarchy (i.e., ordering of information) – Quantity – Materiality and comprehensiveness – Formatting Print: Location, font size/style, contrast, use of white space Non-print: Use of superimposed text, contrast, visual/audio interplay, audio considerations Presenting Risk Information in Prescription Drug and Medical Device Promotion (DRAFT – May 2009)

8 Ongoing FDA Rulemaking and Guidance Development Proposed Rule: Presentation of Major Statement in DTC Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (March 29, 2010) – To implement DTC advertising provisions of FDAAA of 2007 Process to develop guidance for promotion through Internet and social media – Public hearing in November 2009; comments accepted through February 2010 – Focus areas include: Responding to unsolicited requests Fulfilling regulatory requirements when using tools with space limitations Fulfilling post-marketing submission requirements Accountability for on-line communications Use of links on the Internet Correcting misinformation – Relevant new media include: Facebook, consumer DVDs, webcast videos, sales representative videos on web, promotional videos on cnn.com and youtube.com, online banner ads, and sponsored links

9 Industry Standards – PhRMA Guiding Principles for Direct to Consumer Advertisements about Prescription Medicines (March 2009) – 18 guiding principles, including: Compliance with FDA regulations Responsible education of consumers about a drug and the condition(s) for which it may be prescribed Appropriate amount of time to educate health care professionals prior to first DTC campaign Responsible discontinuation or alteration if a serious safety risk emerges Submission of new DTC advertisements to FDA prior to broadcast Acknowledgement if actor is being used, or if health care provider is being compensated for appearance Celebrity endorsements should accurately reflect opinions, findings, beliefs, or experience Content and placement to avoid audiences that are not appropriate – Annual certification by CEO and Chief Compliance Officer to PhRMA office of accountability; public disclosure of certification

10 Industry Standards – AdvaMed Guiding Principles for Direct to Consumer Device Advertising (March 2009) – 13 guiding principles, including: Compliance with all applicable FDA and FTC statutes and regulations Language appropriate to the intended audience Consistency with FTC guidelines for endorsements and testimonials Disclosure if actor is being used, or if health care provider is being compensated for appearance Appropriate amount of time to educate health care professionals prior to first DTC campaign Responsible discontinuation or alteration if a serious safety risk emerges For restricted devices, submission of new DTC advertisements to FDA prior to broadcast

11 Non-Promotional Communications Help-seeking/disease awareness Scientific exchange – Response to unsolicited requests for off-label information – Dissemination of reprints with off-label information – Presentation of data at scientific and/or professional meeting* Communications with consultants and investigators – Subject to bona fide written arrangement Support for independent scientific and educational programs Press releases with data regarding investigational products* * FDA recently clarified that a presentation or discussion of data would be considered promotional if it draws a conclusion about a products safety or efficacy.

12 Differences for Medical Devices and OTC Products Shared regulation between FDA and FTC – In general, FTC regulates advertising and FDA regulates labeling – FDA regulates advertising for restricted medical devices Federal Trade Commission Act prohibits unfair or deceptive acts and practices and false advertising – False advertising: misleading in a material respect – Claims substantiated by competent and reliable evidence – No fair balance requirement – Guidelines for endorsements and testimonials

13 Enforcement FDA – Informal actions: Untitled and warning letters – Formal statutory authorities: Injunction (consent decree), seizure, civil monetary penalties (for false and misleading DTC ads), criminal prosecution Federal and state prosecutors (criminal and civil) – False Claims Act (off-label promotion) Product liability FTC – Administrative challenge to unfair or deceptive advertising Lanham Act (false advertising) State laws governing unfair trade practices Self-Regulation – National Advertising Division of Council of BBBs

14 Trends in FDA Enforcement Increasing number of untitled and warning letters – 21 (2008) – 41 (2009) – 28 untitled, 13 warning – 52 (2010) – 39 untitled, 13 warning Common violations – Omission and minimization of risk information – Unsubstantiated claims of efficacy or safety – Unsubstantiated comparative claims – Promotion of unapproved uses Presentation: Enforcement and Policy Update from DDMAC* Thomas Abrams, DDMAC, FDA (September 20, 2010)

15 FDAs Bad Ad Program Bad Ad Program, launched May 2010 – HCP education to understand impact of misleading advertising and promotion – HCPs encouraged to notify FDA: or 877-RX-DDMAC Year 1 results – Received 328 reports of potentially untruthful or misleading promotion (compared to average of 104 reports/year previously) – Of 328 reports received: 188 were submitted by HCPs, 116 by consumers, and 24 by representatives of regulated industry – Of 188 reports submitted by HCPs, the agency undertook comprehensive review of 87 – DDMAC indicates that the Bad Ad program led to: 3 warning letters (December 2010, March 2011, May 2011) 2 untitled letters (April and May 2011)

16 FDA Approach to New Media Untitled and warning letters – Most common violations are omission or minimization of risk information – 15 of 52 DDMAC letters in 2010 were for promotion in new media – March 26, 2009: Untitled letters to 14 sponsors, citing sponsored links for approximately 50 products that did not provide risk information Caused immediate 59% decline in sponsored link exposures and 84% decline by end of June 2010 DDMAC has advised that companies follow existing regulations and policies regarding promotion, pending further guidance – Abrams (Feb. 2011, DIA): There will be guidance on some more specific matters, but there will be no new regulations or new standards. Look at our recent Warning Letters involving social media, such as Facebook. These Warning Letters cite existing rules and do not make new policy.

17 Recent DDMAC Letters for Online Promotion August 2011: Untitled letter, LIPITOR website – FDA cited Online Resources webpage for making efficacy claims about CADUET, CHANTIX, and NORVASC without communicating any risk information for these products – The fact that a user could access risk information about CADUET, CHANTIX, and NORVASC by clicking on additional links was, according to FDA, insufficient to mitigate the misleading omission of risk information from the Online Resources webpage July 2010: Untitled letter, TASIGNA website – FDA noted that Facebook Share widget on website generated sponsor- created information that could be shared with other Facebook users, and this information Did not include any risk information associated with use of TASIGNA Did not adequately communicate TASIGNAs FDA-approved indication (i.e., indication statements too brief), and Implied superiority over other products (next generation claim)

18 Questions? James S. Cohen McDermott Will & Emery th Street NW Washington, D.C


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