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KNOLL PHARMACEUTICAL CO. v. SHERMAN

August 3, 1999

KNOLL PHARMACEUTICAL COMPANY, PLAINTIFF,
v.
LEN SHERMAN, IN HIS CAPACITY AS DIRECTOR OF THE ILLINOIS DEPARTMENT OF PROFESSIONAL REGULATION; JOHN COGHLAN, IN HIS CAPACITY AS DIRECTOR OF STATE WIDE ENFORCEMENT OF THE ILLINOIS DEPARTMENT OF PROFESSIONAL REGULATION, DEFENDANTS.



The opinion of the court was delivered by: Conlon, District Judge.

  DECISION ON THE MERITS

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 separate grounds.

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.

BACKGROUND

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 if:

  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 into 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, ...

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