Medical Device Advertising Law & Regulation IVT Medical Device Conference San Francisco August 17, 2006

Medical Device Advertising Law & Regulation IVT Medical Device Conference San Francisco August 17, 2006 Michael A. Swit, Esq. Vice President, Life Sciences

Presentation Overview • Basics of the Law • Regulation of Promotion/Advertising • Off Label Promotion & the First Amendment • Other Legal Concerns Impacting Advertising • The AdvaMed Code

Basics • Law – Sec. 502 of Federal Food, Drug, and Cosmetic Act – A device shall be deemed misbranded: • (q) in the case of any restricted device … if (1) its advertising is false or misleading in any particular, or (2) is sold, distributed, or used in violation of regulations prescribe under section 520(e)

Basics … • Misbranded device – Sec. 502(r) -- In the case of any restricted device … includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that device • (1) a true statement of the device’s established name as defined in section 502(e), printed prominently and in type at least half as large as that used for any trade or brand name thereof, and • (2) a brief statementof the intended uses of the device and relevant warnings, precautions, side effects, and contraindications … • … Except in extraordinary circumstances, no regulation … shall require prior approval by the Secretary of the content of any advertisement and no advertisement of a restricted device, published after the effective date of this paragraph shall, with respect to the matters specified in this paragraph or covered by regulations issued hereunder, be subject to the provisions of sections 12 through 15 of the Federal Trade Commission Act (15 U.S.C. 52–55).

Basics … Federal Trade Commission • Unfair or deceptive acts or practices affecting commerce are prohibited. • Section 12 of FTCA – “False advertisements for foods, drugs, devices and services are prohibited.” • FDA vs. FTC – Labeling vs. Advertising

Pre-Approval Promotion • Pending 510(k) • May advertise or exhibit provided the precise regulatory status is stated • May not take orders – CPG 300.600 • May not make safety or effectiveness claims • Can describe clinicals so long as no claim for safety or effectiveness

Pre-Approval Promotion – Pending 510(k) for a Restricted Device • Can not compare to another product • Descriptions must be “fairly balanced” • No safety or effectiveness claims • Can describe clinicals so long as not safety or effectiveness claim made

Pre-Approval – Devices Under IDE • 21 CFR 812.7 – Prohibition of Promotion – a sponsor, investigator, or person acting on behalf of sponsor, shall not: • Promote or test market an IDE device • Commercialize an IDE device • Represent an IDE device is safe or effective for purposes for which it is being studied

Pre-Approval – Devices Under IDE … • Announce availability of device only: • in medical or scientific publications • at medical or scientific conferences • Where readership or attendance is comprised primarily of qualified experts • State purpose is only to recruit investigators and not to make device generally available

Pre-Approval – Devices Under IDE … • Limit information in notice of availability of device to: • Proposed use of device • Name & address of sponsor • How to apply to investigator • How to obtain device for IDE use • Investigator’s duties during the study • Use direct mail solely to solicit qualified investigators (no mass mailings = promotion)

Pre-Approval – Devices Under IDE … • Need “Caution – Investigational Device” legend on solicitation • No claims – direct or indirect – that device is reliable, safe, or effective • No volume discounts for investigational devices • IRB review needed for recruitment materials • Source:Guidance on Preparing Notices of Availability of Investigational Medical devices and for Recruiting Study Subjects http://www.fda.gov/cdrh/comp/2229.pdf

Promotion – Non-Traditional • Trade Show Exhibits • No clear regulation or guidance • OK – • “Pending 510(k), not available for sale within U.S. • “Not available in U..S” – unapproved device • “Work in progress” – if under development • CME – very complicated area • if you support, must limit what you say about off label uses, regardless of whether product is already approved or is still wholly investigational

Promotion – Non-Traditional … • CME … factors FDA reviews to see if independent • Device co. have control over content or speakers • Meaningful disclosures made over Device co.’s support • Does program focus on single product – i.e., Device Co.’s? • Relationship between education provider and sponsor at arm’s length? • Does provider participate in Device Co.’s marketing? • Multiple presentations held?

Promotion – Non-Traditional … • CME … factors FDA reviews to see if independent … • Is audience selected by Device Co.’s sales/marketing? • Is there chance for meaningful discussion/questions? • Is info about Device Co.’s product further disseminated after initial program? • Is program in same meeting room as sales/marketing efforts? • Complaints about Device Co. trying to influence program? • Written agreement between Device Co. & provider?

Promotion – Non-Traditional … • PR and Investor Relations • Product specific press releases are labeling or promotional/advertising • PR materials must jibe with approved labeling • PR on clinical trials should not suggest product is approved or that device is safe or effective • IR materials – similar approach • Internet – treat as if it were hard copy; no “cyber” exemption to compliance duty

Promotion – Non-Traditional … • Unsolicited Requests for Off-Label Info – OK: • If request from health care practitioner • Truly unsolicited • Response is in form of scientific/objective information, limited to question asked and non-promotional in nature • See 21 USC §§ 360aaa-6(a)

Promotion – Non-Traditional … • Dissemination of Peer-Reviewed Journal Articles/Reference Text • Not clear as to what law is • OK under 1997 FDAMA • But, in Washington Legal Foundation cases, held to be unconstitutional, but, due to procedural aspects of case, FDA considers decision not applicable • Legal scholars – doubt FDA would win if case fully tried • FDA – FDAMA was just a safe harbor; sail out of harbor, and you may still be subject to enforcement if intent is to promote off-label

Other Legal Concerns Impacting Promotion/Advertising • Key Other Federal Laws • Federal False Claims Act • Stark Law – Anti-Kickback • False Claims – “Qui Tam” • Law: civil – been around since Civil War • Government can pursue or a “relator” can bring an action – if win, gets a piece of the action • Drug companies – primarily under gun; but, will shift to device firms eventually – • Theory – federal reimbursement is limited to approved claims • Cases – up to $885 MM (TAP Pharm.); $705 MM (Serono)

Other Legal Concerns … • FDA Criminal Prosecution – Pfizer (Parke-Davis) – Neurontin® -- pled guilty to 2 criminal counts • Misbranding drug by failing to provide adequate directions for use (due to off-label) • Introducing unapproved drug into commerce • Stark – Federal Anti-Kickback – criminal offense to give items of value to prescribers; thus, must be very careful with those who are consultants, etc. • State Laws – varied and overlap with state – e.g., false claims

AdvaMed Code • Training & Education of Health Care Providers • Settings must be conducive to education/training • Modest meals and receptions OK • Reasonable travel and lodging • No spouses/guests paid by Device Co.

AdvaMed Code … • Supporting Third-Party Educational Conferences • OK for bona fide educational, scientific conferences via: • Educational grants • Modest meals and hospitality • Faculty expenses • Advertisements and demonstrations

AdvaMed Code … • Sales/Promotional Meetings • OK to meet with health care professionals to discuss product features, negotiate contracts • Companies may provide: • Modest meals and receptions if conducive to information exchange • Reasonable travel costs for attendees • But not for guests or spouses

AdvaMed Code … • Consultants • OK if bona fide consulting & limited to reasonable and actual expenses • How do you know if bona fide? • Written, signed agreement • Fair market value compensation • Legitimate purpose and need for services • Selection based on qualifications (not # of patients) • Venue for meetings is appropriate • Written research protocol • Caution – correlate with money paid to clinical investigators; may trigger financial disclosure duties under 21 CFR 54

AdvaMed Code … • Gifts • Modest • Must benefit patients or service genuine educational function & have value under $100 (except texts and anatomical models) • No cash or equivalents • Reimbursement & Other Economic Info – can be provided, but limited to coverage, codes or billing of products; can’t be used to induce unlawfully use of products (could be kickback)

AdvaMed Code … • Charitable Donations • To charitable organization to support: • Independent medical research • Indigent care • Patient education and public education • Sponsor events if proceeds are charitable • Grants • To advance education of HCPs in training • Support research with scientific merit • Public education regarding health topics

Questions? Call, e-mail, fax or write: Michael A. Swit, Esq. Vice President, Life Sciences THE WEINBERG GROUP INC. 336 North Coast Hwy. 101 Suite C Encinitas, CA 92024 Phone 760.633.3343 Fax 760.633.3501 or 760.454.2979 (preferred) Cell 760.815.4762 D.C. Office 202.730.4123 michael.swit@weinberggroup.com www.weinberggroup.com

About the speaker … Michael A. Swit, Esq., who is Vice President, Life Sciences at THE WEINBERG GROUP INC., has extensive experience in all aspects of FDA regulation with a particular emphasis on drugs and medical device regulation. In addition to his private legal and consulting experience, Mr. Swit also served for three and a half years as vice president and general counsel of Pharmaceutical Resources, Inc. (PRI) a prominent generic drug company and, thus, brings an industry and commercial perspective to his representation of FDA-regulated companies. While at PRI from 1990 to late 1993, Mr. Swit spearheaded the company’s defense of multiple grand jury investigations, other federal and state proceedings, and securities litigation stemming from the acts of prior management. Mr. Swit then served from 1994 to 1998 as CEO of Washington Business Information, Inc. (WBII) a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA publishing company. Before joining THE WEINBERG GROUP, he served in the FDA Regulatory Law Practices at both Heller Ehrman and McKenna & Cuneo, first in that firm’s D.C. office and then in its San Diego office. He first practiced FDA regulatory law with the D.C. office of Burditt & Radzius from 1984 to 1988. Mr. Swit has taught and written on a wide variety of subjects relating to FDA law including, since 1989, co-directing a three-day intensive course on the generic drug approval process, serving on the Editorial Board of the Food & Drug Law Journal, and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved, published by WBII. Mr. Swit holds an A.B., magna cum laude, with high honors in history, in 1979, from Bowdoin College, and earned his law degree from Emory University in 1982. He is a member of the California, Virginia and District of Columbia bars.

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Medical Device Advertising Law & Regulation IVT Medical Device Conference San Francisco August 17, 2006