UNITED STATES COURT OF APPEALS FOR THE D.C. CIRCUIT


WA LEG FDN

v.

HENNEY, JANE E.


99-5304a

D.C. Cir. 2000


*	*	*


Silberman, Circuit Judge: The government appeals a dis- trict court
decision holding that the Food and Drug Adminis- tration Modernization
Act of 1997, which establishes proce- dures by which drug and medical
device manufacturers may  disseminate information about "off-label"
uses for their prod- ucts, violates the First Amendment. In light of
the govern- ment's appellate position that the statute does not
provide it  with independent authority to proscribe speech, we dismiss
 the appeal and vacate the district court's injunction.


* * * *


To secure Food and Drug Administration (FDA) approval  for a drug or
medical device,1 a manufacturer must demon- strate that its product is
safe and effective for each of its  intended uses. See 21 U.S.C. s
355(d); id. at s 360e(e)(1)(A).  It will often be discovered after
initial FDA approval, howev- er, that a drug has uses other than those
for which it was 




__________

n 1 For brevity's sake we use the term "drugs" to encompass  drugs and
medical devices, both of which are regulated under the  statute and
guidance document at issue here.


approved. These so-called "off-label uses" are subject to 
asymmetrical--if not necessarily inconsistent--regulatory treat- ment.
On the one hand, it is unlawful for a manufacturer to  introduce a
drug into interstate commerce with an intent that  it be used for an
off-label purpose, see id. at s 331(d), and a  manufacturer illegally
"misbrands" a drug if the drug's label- ing includes information about
its unapproved uses, see id. at  s 331(a); id at s 352(a); cf. Kordel
v. United States, 335 U.S.  345, 348-50 (1948) (affirming broad
definition of "labeling"  under the Food, Drug, and Cosmetic Act). On
the other  hand, neither Congress nor the FDA has attempted to regu-
late the off-label use of drugs by doctors and consumers. A  physician
may prescribe a legal drug to serve any purpose  that he or she deems
appropriate, regardless of whether the  drug has been approved for
that use by the FDA. See, e.g.,  Citizen Petition Regarding the Food
and Drug Administra- tion's Policy on Promotion of Unapproved Drugs
and De- vices; Request for Comments, 59 Fed. Reg. 59,820, 59,821 
(1994). Although the parties have differing views about the  health
risks and benefits of off-label uses, it is undisputed  that the
prescription of drugs for unapproved uses is com- monplace in modern
medical practice and ubiquitous in cer- tain specialties. See, e.g.,
James M. Beck & Elizabeth D.  Azari, FDA, Off-Label Use, and Informed
Consent: Debunk- ing Myths and Misconceptions, 53 Food & Drug L.J. 71,


While a manufacturer's direct advertising or explicit pro- motion of a
product's off-label uses is likely to provoke an  FDA misbranding or
"intended use" enforcement action,  manufacturers have sought to
employ more indirect methods  of informing physicians about their
products' off-label uses.  This case concerns the FDA's and Congress'
attempts to  regulate two of these promotional strategies:
manufacturer  dissemination to physicians of independent medical and
scien- tific publications concerning the off-label uses of their prod-
ucts, and manufacturer support for Continuing Medical Edu- cation
(CME) programs for doctors that focus on off-label  uses. The FDA's
examination of these practices led to  publication of an agency
enforcement policy set forth in three 


guidance documents. Two of these documents limited the  circumstances
under which manufacturers could permissibly  distribute "enduring
materials"--i.e., journal article reprints  and textbooks--to
physicians. See Guidance to Industry on  Dissemination of Reprints of
Certain Published, Original  Data and Guidance for Industry Funded
Dissemination of  Reference Texts, 61 Fed. Reg. 52,800 (1996)
("Enduring Mate- rials Guidances").2 The third guidance document,
concerning  manufacturer involvement in CME programs (the "CME 
Guidance"), set forth twelve factors that the FDA will consid- er in
determining whether a program is independent of  manufacturer
influence. See Guidance for Industry: Indus- try-Supported Scientific
and Educational Activities, 62 Fed.  Reg. 64,093, 64,096-99 (1997).


Washington Legal Foundation (WLF) brought this action  asserting that
the policies articulated in the Guidance Docu- ments violated the
First Amendment right of its physician  members to receive information
about off-label uses from  manufacturers.3 Cf. Virginia State Bd. of
Pharmacy v. Vir- ginia Citizens Consumer Council, Inc., 425 U.S. 748,
756-57  (1976) (First Amendment protections extend both to distribu-
tion and receipt of commercial speech). The district court, in  its
decision granting summary judgment, began its discussion 




__________

n 2 These Guidances provided that, while a manufacturer- distributed
article could reference a product's off-label use, "the  principal
subject of the article should be the use[ ] ... that has been 
approved by FDA," 61 Fed. Reg. at 52,801; it also stated that the 
manufacturer should indicate clearly to the recipient that the article
 discusses "information that is different from approved labeling." 
Id. The Guidances included similar provisions limiting the dissemi-
nation of medical textbooks where the textbook contains content too 
extensively devoted to off-label uses. See id.


3 WLF's original complaint, filed before the FDA published the 
Guidances, was based on a series of FDA actions taken against 
manufacturers for their dissemination of off-label information that 
WLF asserted constituted final agency policy. See Washington  Legal
Foundation v. Kessler, 880 F. Supp. 26 (D.D.C. 1995). The  Guidance
Documents were published during the course of the  litigation.


of WLF's constitutional claim by classifying the speech being 
regulated. Rejecting both the WLF's contention that the  policies
restricted fully-protected scientific speech and the  FDA's argument
that the speech was constitutionally unpro- tected because it
"proposed an illegal transaction," the court  determined that the
Guidance Documents regulated commer- cial speech. See Washington Legal
Foundation v. Friedman,  13 F. Supp. 2d 51, 62-65 (D.D.C. 1998) (WLF
I). It then  applied the three-part test set forth in Central Hudson
Gas &  Elec. Corp. v. Public Serv. Comm'n, 447 U.S. 557 (1980), to 
determine whether the policies' restrictions on commercial  speech
exceeded constitutional limits. It concluded that the  Guidance
Documents satisfied the first and second parts of  Central Hudson,
since they directly advanced the govern- ment's substantial interest
in encouraging manufacturers to  seek FDA approval for off-label uses.
They fell short of  satisfying the final part of the Central Hudson
test, however,  because the policies restricted considerably more
speech than  necessary to encourage manufacturers to achieve this
objec- tive. See WLF I, 13 F. Supp. 2d at 65-74. Holding that the 
Enduring Materials and CME Guidances violated the First  Amendment,
the court enjoined the FDA from prohibiting  manufacturers'
dissemination of enduring materials "regard- less of whether such
[materials] include[ ] a significant or  exclusive focus" on off-label
uses, and from proscribing manu- facturers from suggesting content to


Shortly after the district court issued its injunction, the  Food and
Drug Administration (FDA) Modernization Act of  1997, Pub. L. No.
105-115, 111 Stat. 2296 (FDAMA or the  Act), became effective. The Act
includes provisions concern- ing manufacturer distribution of enduring
materials on off- label uses that supersede4 the Enduring Materials
Guidances 




__________

n 4 We emphasize that the FDA unequivocally stipulated in its  briefs
and at oral argument that the Act and its implementing  regulations
supersede, rather than supplement, the Enduring Mate- rial Guidances.
And even if they were not superseded, they would  be unenforceable,
since the FDA does not challenge on appeal the 


found unconstitutional in WLF I. See 21 U.S.C. ss 360aaa et  seq. It
specifically authorizes a manufacturer to disseminate  "written
information concerning the safety, effectiveness, or  benefit of a use
not described in the approved labeling of a  drug or device," 21
U.S.C. s 360aaa(a), if it complies with  several requirements: the
manufacturer must submit an ap- plication to the FDA seeking approval
of the drug for the off- label use; the manufacturer must provide the
materials to the  FDA prior to dissemination; the materials themselves
must  be in unabridged form; and the manufacturer must include 
disclosures that the materials pertain to an unapproved use of  the
drug, and, if the FDA deems it appropriate, "additional  objective and
scientifically sound information ... necessary to  provide objectivity
and balance." See 21 U.S.C.  s 360aaa(b)(1)-(6); id. at 360aaa(c); id.
at 360aaa-1. Impor- tantly, the Act amends the Food, Drug, and
Cosmetic Act to  prohibit "[t]he dissemination of information in
violation" of  these provisions. 21 U.S.C. s 331(z); see also id. at 
s 360aaa-4(b)(1) (emphasis added).


After the Act became effective, questions arose concerning  the scope
of the district court's decision and injunction in  WLF I. The
government asserted that the district court's  ruling applied only to
the Guidance Documents, two of which  had been superseded by the Act,
and asked that the district  court confine the application of its
injunction accordingly.  The court denied the FDA's motion, noting
that its "decision  and injunction must be read to apply to the
underlying  policies of the FDA, and not merely to the express
provisions  of the Guidance Documents," Washington Legal Foundation 
v. Friedman, 36 F. Supp. 2d 16, 18 (D.D.C. 1999) (WLF II),  and
requested supplemental briefing on the constitutionality  of the Act's
provisions addressing manufacturer promotion of  off-label uses. In a
subsequent opinion, the district court  held that those provisions,
like the Enduring Materials Guid- ances that preceded them, violated
the First Amendment.  See Washington Legal Foundation v. Henney, 56 F.




__________

n district court's decision and injunction insofar as they pertain to
the  Enduring Material Guidances. See WLF I, 13 F. Supp. 2d at 74.


81 (D.D.C. 1999) (WLF III). The FDA appealed, contending  that the
district court erred in concluding that the FDAMA  and the CME
Guidance are unconstitutional.


The stage therefore appeared set for us to consider a  difficult
constitutional question of considerable practical im- portance.
However, as a result of the government's clarifica- tion at oral
argument, the dispute between the parties has  disappeared before our
eyes. The parties' briefs were quite  confusing as to the meaning of
the Act and the CME Guid- ance, perhaps because both provisions became
effective dur- ing the later stages of the litigation in the district
court.  While WLF clearly understood these provisions as indepen-
dently banning both manufacturer dissemination of enduring  materials
on off-label uses and support for CME conferences,  see, e.g.,
Appellee's Br. at 1, 12-13, 20, 33, the FDA's view of  the Act and the
CME Guidance was somewhat unclear: At  times the FDA appeared to share
WLF's assessment that  these provisions provide legal authorization to
restrict manu- facturer speech, but more frequently the FDA asserted
that  they established nothing more than a "safe harbor" ensuring 
that certain forms of conduct would not be used against  manufacturers
in misbranding and "intended use" enforce- ment actions based on
pre-existing legislative authority.  Compare Appellant's Br. at 34-35
(safe harbor) with id. at  46-47, 51 (describing provisions as
restricting speech, and  noting that "enforcement of the FDCA's
misbranding provi- sion ... is a wholly inadequate substitute for the
FDAMA").  In response to questioning at oral argument, the government 
definitively stated that it subscribed to the "safe harbor" 
interpretation and further explained that, in its view, neither  the
FDAMA nor the CME Guidance independently autho- rizes the FDA to




__________

n 5 The government's position, articulated and repeated several  times
during oral argument, is most succinctly presented by the  following
colloquy:


THE COURT: .... I thought your whole explanation of this  statute and
the guidance was that they have established a  procedure for
manufacturers who distribute certain materials 


pressed government counsel about the significance of 21  U.S.C. s
331(z)--which specifically prohibits "the dissemina- tion of
information in violation of section 360aaa"--he ex- plained that this
provision provides that a manufacturer who  disregards section
360aaa's conditions cannot avail itself of  the FDAMA safe harbor, and
might be liable in some fashion  if it breached an agreement with the
Secretary pursuant to  that section. See Tr. at 34. Were a
pharmaceutical company  to send out reprints of an article devoted to
its drug's off- label uses to thousands of physicians tomorrow, the
govern- ment agreed--indeed stipulated-that the agency would draw  no
independent prosecutorial authority from FDAMA to but- tress any
enforcement proceeding. See Tr. at 60--61. And  the FDA offers a
similar view of the CME Guidance: If a  drug manufacturer wishes to
suggest content to a CME  program provider in a manner that runs afoul
of all the  Guidance's twelve "factors" that, by itself, is not a
violation of  law. See Tr. at 73-74. Although the FDA retains the 
prerogative to use both types of arguably promotional con- duct as
evidence in a misbranding or "intended use" enforce- ment action, cf.
Action on Smoking and Health v. Harris, 655  F.2d 236, 239 (D.C. Cir.
1980) (observing that "it is well  established that the 'intended use'
of a product, within the  meaning of the [Food, Drug, and Cosmetic]
Act, is deter- mined from its label, accompanying labeling,
promotional  claims, advertising, and any other relevant source"
(internal  citations omitted)), the agency insists that nothing in
either of  the provisions challenged in this case provides the FDA




__________

n regarding off-label uses in such a way that they will not be  used as
evidence against them in a prosecution under the  misbranding
provisions. I thought that's what this was about.  And that I thought
that any manufacturer could distribute  anything they wanted, if they
wanted to take a chance of  ending up a defendant in a mislabeling
case. Isn't that right?


COUNSEL: That's all correct. That's all correct.


THE COURT: That's all correct.


COUNSEL: Yes.


Tr. at 31-32.


WLF responded that in light of the government's position  as refined
and explained at oral argument it no longer has a  constitutional
objection to the Act or the CME Guidance,6 see  Tr. at 52, 66-68,
69--a response that, it would seem, eliminates  entirely the only
issues in dispute between the parties in this  case. WLF apparently
believes we should nevertheless af- firm the district court. It is a
well-recognized principle that a  case will not become moot merely
because a defendant agrees  voluntarily to cease engaging in the
challenged conduct, as  there remains a risk that the defendant will
merely resume  the challenged conduct after the case is dismissed.
See, e.g.,  United States v. W. T. Grant Co., 345 U.S. 629, 632
(1953).  Voluntary cessation of challenged conduct will only moot a 
case if "subsequent events made it absolutely clear that the 
allegedly wrongful behavior could not reasonably be expected  to
recur." Friends of the Earth, Inc. v. Laidlaw Environ- mental Servs.
(TOC), Inc., No. 98-222, Slip Op. at 18 (U.S.  Jan. 12, 2000) (quoting
United States v. Concentrated Phos- phate Export Assn., Inc., 393 U.S.
199, 203 (1968)). Relying  on this principle, and apparently concerned
that the FDA will  prosecute manufacturers for violating a normative
standard  set forth in the Act or CME Guidance notwithstanding the 
agency's concession in this case that it has no authority to do  so,
WLF indicates that we should still reach the merits of the  district


We think that WLF misapprehends the nature and signifi- cance of the
FDA's concessions, which do not in our view  implicate principles of
mootness at all. This is not an in- stance of "voluntary cessation,"
since WLF has not alleged  that FDA engaged in any conduct pursuant to
the challenged  statute and guidance document. The relevant question
be- fore us therefore is not whether certain enforcement activities 
conducted under these provisions were unconstitutional (since  there
were no such activities alleged), but instead whether the  statute and
guidance document facially violate the First 




__________

n 6 A manufacturer, of course, may still argue that the FDA's use  of a
manufacturer's promotion of off-label uses as evidence in a 
particular enforcement action violates the First Amendment.


Amendment. Since both parties now agree that they do not,  there is no
constitutional controversy between the parties  that remains to be
resolved; we do not think it at all  appropriate to rule on the
constitutionality of a hypothetical  interpretation of a statute, see
Aetna Life Ins. Co. v. Ha- worth, 300 U.S. 227, 240-41 (1937)
(distinguishing a justiciable  controversy from "a difference or
dispute of a hypothetical or  abstract character"), which is what WLF
in effect requests by  suggesting that we "reach the merits" of the
district court's  decision. The government has announced here nothing
less  than an official interpretation of the FDAMA which the  agency
may not change unless it provides a reasoned explana- tion for doing
so. See Amax Land Co. v. Quarterman, 181  F.3d 1356, 1365 & n.6 (D.C.
Cir. 1999). It goes without  saying that an attempt to evade judicial
review in this case  would hardly be a legitimate basis. Cf. AT & T v.
FCC, 978  F.2d 727, 731-32 (1993).


Accordingly, we dismiss the FDA's appeal and vacate the  district
court's decisions and injunctions insofar as they de- clare the FDAMA
and the CME Guidance unconstitutional.7


So ordered.




__________

n 7 In disposing of the case in this manner, we certainly do not 
criticize the reasoning or conclusions of the district court. As we 
have made clear, we do not reach the merits of the district court's 
First Amendment holdings and part of its injunction still stands.