THE FIRST AMENDMENT’S IMPACT ON FEDERAL

REGULATION OF ADVERTISING AND PROMOTION

Michael A. Swit, Esq.Law Offices of Michael A. Swit

760-815-4762mswit@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

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.”

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?

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

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”)

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)

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

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

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

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;

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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”

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

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”

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.

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

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”

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?

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

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

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

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

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.”

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”

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

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

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

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 …

The End

Questions?

Michael A. SwitAttorney at Law

Law Offices of Michael A. Swit539 Samuel Ct. , Suite 229 ♦ Encinitas, CA 92024

Office: 760-815-4762 ♦ O-Fax: 760-454-2979mswit@fdacounsel.com

Also Admitted In Virginia and D.C..

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.