WLF/FDAMA ruling upheld

Editor's note: This article discusses a controversial district court decision regarding prescription drug promotion that presents uncharted territory for the FDA and many pharmaceutical companies. Although Pharmaceutical Representative feels sales reps should be aware of the court's decision, the editors recommend that sales reps not take it upon themselves to interpret the legal implications of the ruling for their own detailing habits; instead, sales reps should follow the leads set by their respective sales organizations.

The rules surrounding off-label promotion came under fire in a Washington district court on July 28, when Judge Royce Lamberth handed down a decision that will undoubtedly change the marketing of prescription drugs in the next millennium.

In his latest of three rulings on WLF vs. Henney, Lamberth decided that the Food and Drug Administration does not have the right to restrict the pharmaceutical industry's dissemination of bona fide, peer-reviewed articles, textbooks and continuing medical education seminar programs that discuss off-label uses, despite regulations established by the FDA under the FDA Modernization Act of 1997.

The basis for his ruling? The FDA's restrictions and regulations violate the pharmaceutical industry's right to free speech, as defined in the First Amendment, according to the court.

Furthermore, Lamberth ruled that the FDAMA "largely perpetuates the policies held unconstitutional by the Court" and therefore "may not be applied or enforced by the FDA." As a result, legal experts, the pharmaceutical industry and the FDA are left wondering what exactly the FDA can and will enforce regarding off-label promotion of prescription drugs. (See p. 13.)

The unraveling of FDAMA

Concerns regarding the FDA's efforts to regulate pharmaceutical industry and medical device industry practices surrounding off-label promotion were raised by the Washington Legal Foundation, a non-profit legal organization that devotes itself to protecting and enforcing the First Amendment. Holding the opinion that FDA was infringing upon freedom of speech, the WLF filed suit - an action pharmaceutical companies may have hesitated to take because they feared repercussions in the drug approval arena.

On July 30, 1998, Lamberth decided in favor of WLF, stating that some FDA regulatory policies about off-label uses violated the First Amendment. The FDA sought a clarification of the decision, asking Judge Lamberth to amend the order to state that his ruling did not cover FDAMA.

Lamberth reviewed the case again, and in February (See Pharmaceutical Representative, May 1999) ordered both the WLF and the FDA to submit arguments as to whether the provisions in FDAMA were constitutional. His most recent ruling reflects his opinion on that matter.

Lamberth based his final decision on the following grounds: The speech at issue was neither false nor inherently misleading, only one provision in FDAMA directly advanced FDA's "substantial government interest" in encouraging manufacturers to seek FDA approval of off-label uses and the supplemental application requirement in FDAMA "burdens substantially more speech than necessary."

What now?

It is unclear how the FDA will proceed from here. As one attorney following the case said, "Traditionally, the FDA does not lose in court. The FDA doesn't lose, period." The WLF vs. Henney decision sharply corrected this precedent, and will likely lend a strong hand in shaping the FDA's future efforts to regulate the industry.

As for the pharmaceutical industry, the WLF vs. Henney decision leaves it with no formal guidance on off-label promotion. Lamberth's ruling defended FDA's legitimate interest and right to regulate the industry in some way, but the ruling leaves sales organizations with a policy subject to interpretation. PR