This document summarizes the impact of the First Amendment on the regulation of advertising and promotion by the FDA. It discusses key court cases that have established protections for commercial speech related to pharmaceutical products. It outlines the Central Hudson test for evaluating restrictions on commercial speech and describes FDA guidance and regulations regarding off-label promotion as well as industry-supported medical education. The document focuses on lawsuits brought by the Washington Legal Foundation challenging FDA restrictions as violating the First Amendment.

1. FDACounsel.com
THE FIRST AMENDMENT’S IMPACT
ON FEDERAL REGULATION OF
ADVERTISING AND PROMOTION
Michael A. Swit, Esq.
Law Offices of Michael A. Swit
760-815-4762
mswit@fdacounsel.com

2. FDACounsel.com
1st AMENDMENT
Congress shall make no law respecting an
establishment of religion, or prohibiting
the free exercise thereof; or abridging
the freedom of speech, or of the press;
or the right of the people peaceably to
assemble, and to petition the
Government for a redress of grievances.
December 15, 1791

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185 YEARS LATER …
 1976 -- Virginia Pharmacy Board – U.S.
Supreme Court recognizes that
“commercial speech” enjoys 1st
Amendment protection, but not to the
same extent as “traditional” speech,
such as involved in political discourse.
 “Commercial Speech” – “expression related
solely to the economic interests of the
speaker and its audience.”

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CENTRAL HUDSON TEST
 1980 – Central Hudson decision –
established criteria for government
regulation of commercial speech
 Is the speech related to an unlawful
activity or is it misleading?

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CENTRAL HUDSON “TEST” …
 If not, then to regulate, the government
must:
 Assert a substantial interest to be achieved
by restricting commercial speech
 Use a regulatory approach that is
proportionate to that substantial interest
 Design a speech restriction that carefully
achieves the government’s goal; i.e., must:
 Directly advance state interest involved; and
 Be “narrowly drawn” – i.e., a more limited restriction
on commercial speech must not be available

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FDA & CONTROLS ON OFF-
LABEL USE
 1993 – Washington Legal Foundation
(“WLF”) petitions FDA to loosen
restrictions on unapproved or unlabeled
uses of approved drugs or devices.
 Catalyst – FDA letters and calls to
firms warning vs. unsolicited
distribution of textbooks and peer-
reviewed articles (“enduring materials”)

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FDA & CONTROLS ON OFF-
LABEL USE …
 1994 – after FDA denies petition, WLF
sues agency in U.S. Dist. Ct. in D.C.
 Oct. 1996 – while lawsuit in discovery,
FDA issues 2 guidances:
 Reprints of Certain Published, Original Data
 Industry-Funded Dissemination of
Reference Texts
 61 Fed. Reg. 52800 (Oct. 8, 1996)

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FDA & CONTROLS ON OFF-
LABEL USE …
 REPRINTS GUIDANCE -- 1996
 Article’s main subject had to be approved use
 Peer reviewed journals only
 Must relate to a study that was part of substantial
evidence conclusion for NDA approval or as
evidence of a device’s safety or effectiveness
 Had to highlight any information in article that
differed from the approved labeling

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FDA & CONTROLS ON OFF-
LABEL USE …
 INDUSTRY FUNDED TEXTBOOKS GUIDANCE
– 1996
 Text must not have been written, edited, etc. for
or at request of a regulated firm, unless text is a
“balanced presentation” via a process fostering
input from a “relatively wide spectrum of sources”
 Content not reviewed, edited or “significantly
influenced” by regulated firm
 Text must be generally available from channels
other than regulated firm

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FDA & CONTROLS ON OFF-
LABEL USE …
 INDUSTRY FUNDED TEXTBOOKS
GUIDANCE – 1996 …
 Text should not focus primarily on product
of disseminating firm
 No product info inserts of disseminating
firm’s products
 Firm can not refer or promote, in any
manner or at any time, information in text
on unapproved use of its product

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FDA & CONTROLS ON OFF-
LABEL USE … FDAMA § 401
 Enacted – November 21, 1997 – said to create a
“Safe Harbor” For Off-Label Use
 Supersedes 1996 Guidance on reprints & texts
 Seen as being of very limited utility
 How it works:
 Recipients limited -- OK to disseminate to unapproved use
info for an approved product to:
 health care practitioner
 pharmacy benefit manager
 health insurance issuer
 a group health plan, or
 a Federal or State governmental agency;

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FDAMA § 401 …
 How it works …
 Must be “authorized information” -- § 552 of
Federal Food, Drug, and Cosmetic Act (“Act”)
 Unabridged reprint/copy or a reference publication
 “reference pub.” – similar to Oct. 1996 Guidance
 Peer-reviewed
 in a “scientific or medical journal” – §556(5)
 About a clinical investigation on drug or device
 “scientifically sound”
 Not false or misleading
 No “significant risk” to public health

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FDAMA § 401 …
 How it works …
 Can’t be research on someone else’s product
unless have their OK
 60 days pre-use notification to FDA
 Copy of off-label information
 “any clinical trial information” have on the product – i.e.,
beyond that in the proposed off-label info
 Must have filed for supplemental approval for the
off-label use – per §554

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FDAMA § 401 …
 How it works …
 Include with info a prominent disclaimer:
 Info concerns an unapproved/cleared use
 If applicable, that info disseminated at mfr.’s expense
 Names of any authors who are mfr.’s employees or
consultants or who have received compensation from
mfr. or have “significant financial interest” in mfr.
 If applicable, that there are approved products for the
use in question
 I.D. of any person who provided funding for the article
 Include with info a bibliography of other articles
on that off-label use

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FDAMA § 401 …
 How it works …
 FDA can conclude that the info fails to be
“objective and balance”
 Must give you notice and chance for a meeting
 Can order you to disseminate additional
“objective and scientifically sound” info or a
summary of such
and
 “An objective statement” by FDA on the use

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FDAMA § 401 …
 How it works:
 Must file information biannually with FDA on
all off-label information disseminated in last 6
months & categories of providers
 Continuing Duty to submit more data
 Corrective Action – if FDA, based on post-
dissemination data, concludes the new use is not
effective or a significant risk to public health, can
take appropriate action to protect public health

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FDAMA § 401 …
 How it works …
 Cessation Order – possible in some
circumstances:
 Supplemental application lacks adequate
information to approve new use
 Don’t file supplement after promising to do so
 FDA can order you to take corrective action
relative to the disseminated off-label info

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FDAMA § 401 …
 Other Key Provisions
 § 401 n/a to unsolicited requests from a
health care practitioner
 If you meet § 401, FDA can’t construe fact
you disseminated off-label use info as
evidence of a new intended use
 Added 201(z) – violation of § 551 of Act
(as created by FDAMA) = “prohibited act”
 Sunset – November 20, 2005

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1998 REGULATIONS
 November 20, 1998 – 63 Fed. Reg.
64556
 Created 21 CFR Part 99
 Provides more detail to § 401 language
– particularly the information required
in the 60-day pre-dissemination
submission to FDA

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FDA & CONTINUING MEDICAL
EDUCATION (CME)
 1992 – Draft Guidance on Industry-Supported
Scientific and Educational Activities (ISSEA)
 December 3, 1997 – Final Guidance – 62 Fed.
Reg. 64074:
 “…programs and materials performed and
disseminated by [or on behalf of] companies
are subject to labeling and advertising
provisions” of the Act

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FDA & CME …
 1997 Guidance …
 “truly independent and non-promotional industry-
supported activities have not been subject to FDA
regulation.2
”
 Footnote 2 – independence is an indication of
nonpromotional nature
 Unapproved uses – not permissible in programs
subject to substantive influence by companies that
market product related to the program subject

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FDA & CME …
 The 1997 Guidance …
 Looking at direct and indirect influence
 Statement of FDA enforcement policy
 Activities subject – relate to company’s
products or competitive products
 “Independence factors”
 Control of content and selection of
presenters and moderators

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FDA & CME …
 The 1997 Guidance …
 “Independence factors” …
 Disclosures – meaningful to audience at time
of program, on:
 Company funding of program
 Significant relationships between educational
provider, presenter or moderator and company, like:
 Employees
 Grant recipients
 Stock ownership
 Whether any unapproved uses will be discussed

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FDA & CME …
 The 1997 Guidance …
 “Independence factors” …
 Program Focus
 Does program title fairly reflect scope of program
 Is central theme based on single product or
competing product? [i.e., does it limit discussion of
alternative therapies?]
 Relationship Between Education Provider
& Co.
 Example – does the provider depend on company for
its viability

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FDA & CME …
 The 1997 Guidance …
 “Independence factors” …
 Provider involvement in Sales or
Marketing of company product
 Provider’s Demonstrated Failure to Meet
Standards
 Multiple Presentations of Same Program
 Audience Selection – does it reflect “sales or
marketing goals” – e.g., high prescribers

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FDA & CME …
 The 1997 Guidance …
 “Independence factors” …
 Opportunities for Discussion
 Dissemination – further by company after
program
 Ancillary Promotional Activities – are sales
guys in meeting room?
 Complaints – on company attempts to
influence
 “Additional Considerations”

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FDA & CME …
 The 1997 Guidance …
 “Additional Considerations”
 Written agreement between company &
provider spelling out independence
 Not required, “can provide valuable evidence” of
independence
 Post-Guidance Regulatory Action – none

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THE WASHINGTON LEGAL
FOUNDATION CASES
 Lawsuit -- filed in 1994 – aimed at off-
label dissemination of reprints/copies &
texts and CME
 WLF I -- July 30, 1998 – District Court
Decision –granting WLF summary
judgment
 Rejected WLF claim that speech here was
“scientific and academic” – highest form;
ruled = “commercial speech”

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WLF Cases …
 WLF I -- FDA – tried to assert it was
regulating conduct, not speech, and as part
of a pervasive statutory scheme to regulate
drugs – Court rejected – still have to consider
1st Amendment
 FDA – an unapproved use means product is illegal,
thus not entitled to 1st Amendment protection
under Central Hudson test
 Court – the speech must be about illegal conduct
– here, the conduct would be the doctor’s off-label
prescribing – which is legal.

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WLF Cases …
 WLF I -- Court – FDA had a substantial
interest in getting companies to pursue
approval of off-label uses, but the
guidances went too far in seeking that
goal – less burdensome speech
restrictions existed:
 full disclosure

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WLF Cases …
 WLF I -- FDA’s regulatory efforts can’t be
paternalistic – i.e., assume reader will use
unwisely
 WLF I -- 1998 Summary Judgment Order
 FDA may require conspicuous disclaimers
 FDA may require reprints be from “bona fide peer
review journals”
 FDA may require textbooks be from “bona fide
independent publisher”

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WLF Cases …
 WLF I -- 1998 Summary Judgment Order …
 FDA may require CME sponsors be an accredited
“independent program provider”
 FDA may not restrict co. from suggesting speakers
to an independent provider even if unapproved
uses are discussed
 WLF II -- 1999 Motion – does July 1998
order apply to FDAMA § 401 and 11/98 regs?

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WLF Cases …
 WLF II -- 1999 Motion …
 Yes – while 3 guidances involved, the
underlying policies are subject to decision
 But, requested briefing on impact on
FDAMA (even though Ct. recognized that
FDAMA “largely perpetuated” the
guidances); so decision then limited to the
guidances

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WLF Cases …
 WLF III – July 1999 – on full briefing,
District Ct. held FDAMA and
implementing regulations & the 3
guidances violated 1st Amendment;
entered permanent injunction
 Called FDAMA requirement to file a
supplement “constitutional blackmail”
 Order – related to dissemination to
physicians or other medical professionals

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WLF Cases…
 WLF IV -- Feb. 2000 Decision – U.S. Ct. of Appeals
 FDA – conceded FDAMA did not give it independent
authority to proscribe speech;
 merely created a “safe harbor” under which
dissemination consistent with FDAMA could not be used
to show intent
 WLF – said, if FDA says it’s just a safe harbor and does not
authorize limits on speech, then we have no constitutional
question here
 Court – thus, no controversy; and FDA can’t change its mind
later without a “reasoned explanation”
 Vacated District Court decision

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WLF Cases …
 March 16, 2000 – FDA notice on WLF Cases – 65
Fed. Reg. 14286
 reiterated that FDAMA = “safe harbor”
 If you don’t follow the rules for a safe harbor, you expose
yourself to enforcement action
 Indicate how FDA will exercise enforcement discretion
 Still leaves open question of constitutionality of
dissemination outside the harbor that leads to FDA
action !!!
 WLF V – Nov. 2000
 WLF moved to confirm and enforce the 1999 permanent
injunction
 Court – the Court of Appeals decision vacates the entire
injunction as it rested solely on constitutional grounds

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WLF Cases …
 Net result – this order “will do little to
resolve the issue that lies at the heart
of the dispute: whether the FDA
violates the First Amendment by
penalizing drug manufacturers for
sending scientific literature to
physicians regarding off-label uses.”

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WLF – Where today?
 May 2001 – WLF petitions FDA to
withdraw the March 2000 F.R. notice,
cites FDA regulatory action on reprints:
 New Star Lasers, Inc. for reprints saying
“Wrinkle Treatment Indication Pending FDA
Clearance”

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WLF – Where Today?
 January 2002 – FDA Reply to WLF C.P.
 FDA will ensure its personnel understand there is no
independent bar on off-label dissemination or CME
 Reiterated FDAMA safe harbor and that CME Guidance =
safe harbor
 But, stressed that the act of disseminating off-label could be
used to infer intent to distribute an unapproved new drug
 FDA – unlikely to rely solely on dissemination of unapproved
uses to support enforcement –
 dismissed New Star enforcement action as an issue because
other indicia of intent were present
 WLF – FDA’s position “chills speech”, but have to
wait for enforcement action to raise 1St Amendment
issue again

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WESTERN STATES MEDICAL
 FDAMA §127 – created § 503A – “safe
harbor” for compounding pharmacies from
violating new drug laws by manufacturing (as
opposed to compounding) – but linked to
restrictions on promotion and advertising of
the compounded products --
 Challenged by several compounding
pharmacies

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WESTERN STATES MEDICAL …
 Supreme Court – ruled the restrictions
on promotion and advertising violated
1st Amendment; stressed that, in
accomplishing its statutory duties, FDA
(and Congress in enacting FDAMA)
must regulate speech as a last resort

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THE FUTURE OF FDA & 1ST
AMENDMENT?
 May 2002 – FDA issues a Federal Register
notice seeking comment on how it should
conduct its activities in the light of 1st
Amendment concerns;
 100’s of comments filed
 Effort – still pending
 No legal challenges raised either (to my
knowledge)
 Stay tuned …

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The End

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Questions?
Michael A. Swit
Attorney at Law
Law Offices of Michael A. Swit
539 Samuel Ct. , Suite 229 ♦ Encinitas, CA 92024
Office: 760-815-4762 ♦ O-Fax: 760-454-2979
mswit@fdacounsel.com
Also Admitted In Virginia and D.C..

45. FDACounsel.com
About your speaker
Michael A. Swit has over 19 years of experience addressing critical FDA legal and
regulatory issues. His vast and varied experience, which he is now providing as a solo
practitioner, includes serving 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-regulated community. From May 2001 to to May
2002, Mr. Swit was special counsel in the FDA Law Practice Group in the San Diego
office of Heller Ehrman White & McAuliffe. Before that, he was twice in private
practice with McKenna & Cuneo, from 1988 to 1990 and, most recently, from 1999 to
2001, first in that firm’s D.C. office and most recently, 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 and editing a guide to the generic drug approval process, Getting Your
Generic Drug Approved. He is a member of the California, Virginia and District of
Columbia bars.