Legal expert watches FDA

January 1, 2000

Pharmaceutical Representative

A paper published in the October 1999 issue of Washington Legal Foundation's Contemporary Legal Notes questions whether the Food and Drug Administration's policies regarding direct-to-consumer advertising is deserving of the same First Amendment scrutiny as the FDA's policy regarding off-label promotion.

A paper published in the October 1999 issue of Washington Legal Foundation's Contemporary Legal Notes questions whether the Food and Drug Administration's policies regarding direct-to-consumer advertising is deserving of the same First Amendment scrutiny as the FDA's policy regarding off-label promotion.

According to the paper, written by attorney Sandra Dennis, a partner in the law firm Morgan, Lewis & Bockius, "The primary question is the same: Are FDA restrictions on truthful, non-misleading speech an undue burden on constitutionally protected speech?"

In 1998, the nonprofit Washington Legal Foundation challenged the constitutionality of rules and regulations outlined in the FDA Modernization Act, which had been passed by Congress. After months of review and re-review, a Washington district court ruled in WLF vs. Henney that the FDA does not have the right to restrict the pharmaceutical industry from disseminating peer-reviewed articles, textbooks and continuing medical education seminar programs that discuss off-label uses. The court reached its decision after it determined that the FDA had overstepped its regulatory authority and encroached upon free speech protections guaranteed by the First Amendment.

Dennis, whose firm practices law independent of the Washington Legal Foundation, could not comment as to whether the advocacy group was planning a direct-to-consumer challenge similar to that posed in WLF vs. Henney. However, she did say that a case could be made along similar lines.

"Because consumers are involved, people are obviously going to be much more conservative and protective," Dennis said. "Then again, First Amendment cases lately have been very pro free speech, and there have been cases that have permitted more speech rather than less for consumers in the area of dietary supplements and in other areas as well." PR