Presentation to the IVT Medical Device Conference. San Francisco. August 17, 2006. Talk focused on: Basics of the Law Regulation of Promotion/Advertising Off Label Promotion & the First Amendment Other Legal Concerns Impacting Advertising The AdvaMed Code

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

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

3. 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)

4. 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 statement of 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).

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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)

11. 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

12. 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

13. 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?

14. 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?

15. 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

16. 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)

17. 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

18. 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)

19. 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

20. 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.

21. 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

22. 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

23. 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

24. 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)

25. 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

26. 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

27. 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.

28. For more than twenty years, leading companies have depended on
THE WEINBERG GROUP when their products are at risk.
Our technical, scientific and regulatory experts deliver the crucial
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