The opinion of the court was delivered by: Conlon, District Judge.
Merida is a prescription weight-loss drug classified as a
controlled substance. Meridia is publicly advertised in
nationally distributed magazines, newspapers, and on broadcast
and cable television. Illinois officials have notified Meridia's
manufacturer, Knoll Pharmaceutical Company ("Knoll"), of their
intent to take enforcement action against Knoll under an Illinois
law that bans advertising of controlled substances by name. Knoll
challenges the constitutionality of the Illinois law on three
This court granted Knoll's motion for a temporary restraining
order. By agreement, the restraining order continues in effect
pending a decision on Knoll's request for a permanent injunction.
An evidentiary hearing was held, oral arguments were conducted,
and the issues are fully briefed. All material facts are
undisputed. The court enters the following findings of fact and
conclusions of law in accordance with Rule 52(a) of the Federal
Rules of Civil Procedure.
A. FOOD AND DRUG ADMINISTRATION APPROVAL
Knoll developed Meridia (sibutramine hydrochloride monohydrate)
as a prescription weight loss agent to aid in the treatment of
obesity. Meridia is an amphetamine analogue that stimulates the
central nervous system. Before marketing Meridia, Knoll was
required to obtain Food and Drug Administration ("FDA") approval
establishing that the drug is safe and effective.
21 U.S.C. § 355. The exhaustive FDA approval process requires an applicant to
submit: proposed labeling; statements of the drug's potential
adverse effects and interactions with other drugs, arranged by
gender, age, and racial subgroups; and full reports of multiple
studies of the drug, its absorption rate, its effect on a
developing fetus, and an integrated summary of all available
information about its safety. 21 C.F.R. § 314.50. In order to
assess potential risks, the FDA further requires a description
and analysis of information relating to abuse or over dosage of
the drug. 21 C.F.R. § 314.50(d)(5)(vii). Knoll complied with
these procedures. In November 1997, the FDA found Meridia to be
safe and effective for management of obesity, including weight
loss and maintenance of weight loss, used in conjunction with a
reduced calorie diet. The FDA also approved Meridia's draft
labeling and required Knoll to submit its proposed promotional
material and packaging for approval.
As part of the approval process, the FDA conducted an abuse
liability assessment of sibutramine, Meridia's main component. As
a result, the FDA recommended to the Drug Enforcement
Administration ("DEA") that sibutramine be placed in Schedule IV
of the Federal Controlled Substances Act. Knoll assented to the
FDA's scheduling recommendation. DEA placed sibutramine in
Schedule IV. 63 Federal Register 6862-6864 (February 11,
1998).*fn1 The standards for Schedule IV classification apply
The drug . . . has a low potential for abuse relative
to the drugs . . . in Schedule III; [the] drug . . .
has a currently accept[able] medical use in U.S.;
[a]buse . . . may lead to limited physical . . . or
psychological dependence relative to the drugs . . .
in Schedule III.
21 U.S.C. § 812. Meridia is classified with Schedule IV
stimulants: drugs that have "a stimulant effect on the central
nervous system." 21 C.F.R. § 1308.14(e).
Knoll then developed a national advertising campaign, subject
to FDA review and approval. Federal law bars only advertising
Schedule I controlled substances, which are unsafe drugs with a
high potential for abuse and no currently accepted medical use;
advertising Schedule IV controlled substances is not prohibited
by federal law. 21 U.S.C. § 843(c). The FDA has responsibility
for insuring that the advertising of prescription drugs is not
false or misleading. 21 U.S.C. § 352(n). Specific requirements
are set by the FDA for advertising prescription drugs:
information on side effects, contraindications, warnings and
precautions; the manner in which clinical data or safety and
effectiveness claims may be cited; the layout and size of the
drug name, ingredients, side effect information and dosage.
21 C.F.R. § 202.1. The FDA actively participated in the wording of
Meridia advertisements. All potential risk information —
including the controlled nature of sibutramine — is clearly
presented to consumers. The FDA approved Knoll's proposed
nationwide print and broadcast consumer advertising.
B. MERIDIA'S NATIONAL ADVERTISING CAMPAIGN
A massive advertising campaign was launched in October 1998.
Knoll used a New York-based advertising company, Foote, Cone &
Belding, to run the campaign nationally on television and in
print. Meridia commercials have appeared on all major television
network and cable programming. Pl.Ex. 3. Full page advertisements
have appeared in nationally circulated newspapers, such as The
New York Times Sunday edition, The Wall Street Journal, The
Chicago Tribune and The Los Angeles Times. E.g., Pl.Ex. 6.
Prominent multiple-page advertisements have appeared in
nationally marketed magazines, including Family Circle, People,
and Fitness. Pl.Ex. 7.
Knoll also maintains a consumer website on the internet as part
of its Meridia advertising program. Pl.Ex.10. The website is
international in scope.
The uncontroverted evidence establishes there is no practicable
way Illinois can be selectively blacked out of Meridia's national
advertising. There are 200 television marketing areas in the
United States configured by broadcast signals. State boundaries
are irrelevant. Nielsen's designated market area map, commonly
used in the advertising industry, shows there are ten separate
markets that come into contact with the State of Illinois. Pl.Ex.
5. Illinois marketing areas cross state lines into Iowa,
Missouri, Kentucky, Tennessee and Indiana. Id. Technologically,
television commercials cannot be blacked out in Illinois
marketing areas without blacking out marketing areas that extend
states adjacent to Illinois. Even if all ten marketing areas that
include Illinois were blacked out, there is a 10 percent error
rate in blackout effectiveness for scheduled programming and a 60
percent error rate for live programs like the Today Show. And
Illinois viewers with satellite television could still pick up
blacked out commercials from non-Illinois marketing areas.
Moreover, there is no available technological means to only black
out Illinois in the cable television market. It is impossible to
prevent Illinois residents from accessing Knoll's Meridia
website. Finally, there is no practicable way advertising can be
run in a nationally distributed newspaper or magazine for 49
states, blacking out just Illinois. In sum, a ban on advertising
Meridia in Illinois can be effective only if Meridia's national
advertising campaign is terminated.
C. PUBLIC HEALTH EVIDENCE
Knoll's assertions of Meridia's effectiveness in treating
obesity, as well as the serious health problems associated with
obesity, are unchallenged. In its petition to DEA for
declassification of Meridia as a controlled substance, Knoll
reports it has gathered substantial evidence ("chemical,
preclinical, clinical, postmarketing") of sibutramine's lack of
abuse potential. Pl. Ex. 16. More than 1.5 million prescriptions
for Meridia were dispensed to 835,000 patients by the end of
March 1999. Id. According to Knoll's DEA submission,
[M]ultifaceted initiatives monitoring known drug
abuser populations, drug exposure outcomes,
spontaneous adverse event reporting, drug
abuse-related internet archives, and local sales and
distribution, have yielded no reports indicating
Meridia abuse. Similarly, Knoll is not aware that the
FDA has received adverse event reports of chemical
dependency associated with Meridia, ...