Judicial Beat

First Amendment Applies to FDA
 Court Sees Medical Reprints as ComSpeech; Issue Looms Over Speech Content v. Context

By Robert M. O'Neil

What may well have been the longest running commercial speech drama in the federal courts has finally been resolved. As with many such cases, the outcome is mixed; for the commercial speech community, there is more good news than bad in WLF v. Kessler, although the decision contains several cautions.

The issue was how far the Food and Drug Administration could, consistent with the First Amendment, regulate dissemination by drug manufacturers of reprints from refereed journals and medical textbooks in connection with off-label uses of FDA-approved drugs.

When the FDA issued "guidance documents" restricting such communications, the Washington Legal Foundation brought suit, claiming that such materials were fully protected expression. Even if they were deemed less deserving because of the nexus to promotional activity, these publications were surely entitled to the level of First Amendment protection accorded commercial speech, WLF said. In late July, Judge Royce Lamberth accepted the lesser of these claims and applied what he deemed the applicable commercial speech standard. In the process he enjoined further enforcement of the"guidance" documents.

First Judge Lamberth held that the reprints could hardly be deemed per se "deceptive or misleading" when they were sent by drug companies, if they were (as everyone agreed) fully protected in any other context.

Second, he found one of the FDA's two asserted interests to be substantial — the goal of "compelling manufacturers to get off-label treatments on-label" — though he chided the agency for its other claimed interest (preventing possible misuse by physicians), since "the Supreme Court has repeatedly rejected governmental attempts to equate less information with better decision-making."

WLF Decision Good for Consumers, CME Providers

The best thing about the ruling in WLF v. Kessler: Doctors and patients will likely learn more about the drugs that cure disease, alleviate pain, extend the quality and length of life, and even save money. All this is possible because Judge Lamberth's decision demolishes many of the artificial barriers to communication the FDA put between doctors and drug companies.

For example, drug companies more easily will be able to hire advertising agencies that are accredited providers of continuing medical education (CME) to educate doctors about both on-label and off-label uses of their drugs so long as reasonable caution is taken to ensure that the information is scientifically sound and material matters are fully disclosed.

Commercial CME providers thus gain a strong weapon in their fight against the growing monopoly of medical school CME programs favored by the FDA.

The decision does not end all marketing struggles with the FDA and will certainly be appealed by the agency. But the ruling delivers a stunning blow to FDA assertions that the First Amendment does not apply to its marketing restrictions.

If sustained, the ruling shifts the legal burden from pharmaceutical companies to the FDA for marketing questions.

However, the decision does not address the egregious off-label provisions of the 1997 amendments to the FDA Act. The ruling likely requires that the FDA review its proposed implementing policies, and sets up a possible legal challenge to the off-label provisions of the new statute.

— John Kamp

Third, Judge Lamberth ruled that the Guidance documents directly and materially advanced the FDA's one legitimate regulatory interest. However, that interest could be better served by far less intrusive means, the court ruled. "Full disclosure not only addresses all of the concerns advanced by the FDA, but addresses them more effectively" in a way that is "less restrictive on speech," the court said. On that basis, the court ruled that the challenged guidance failed Central Hudson Part 4 because it was "more extensive than necessary" and "unduly burden[ed] important speech."

There is little doubt that the free speech claims advanced on behalf of drug manufacturers won the battle. The remaining and difficult question is who really won the war — the broadest issue of the nature and legal character of the communications before the court.

That issue, as Judge Lamberth posed it, was this: "Does speech that would be fully protected as scientific and/or educational speech become transformed into commercial speech, with its reduced level of protection, by the mere fact that a commercial entity seeks to distribute it in order to increase its sales of the product addressed in the speech?"

Though Judge Lamberth responded affirmatively — and then went on to find in the companiesı favor anyway — the better answer would seem to be "no." The material was fully protected expression in any other context — when sent, for example, by one physician to another.

Moreover, as Judge Lamberth recognized, even when used to support a particular product or its use, such material did far more than "propose a commercial transaction." Yet the court concluded that the primary use of the reprints in so commercial a setting did serve to transform their basic nature for First Amendment purposes.

That ruling turned out to be of little immediate consequence, given the disposition of the case, but may be the most portentous part of the judgment.

The issue of commercial speech and potentially transforming context deserves far more attention than it has received from courts and commentators. While the Supreme Court has never ruled precisely on the point, Justice Stevens has often cautioned against an overly rigid classification of ambiguous material on the basis of its usage, in disregard of its content. And the justices were very careful a third of a century ago to treat the "editorial advertisement" in the New York Times libel case as fully protected expression, even though its appearance in the paper had been bought and paid for, line by line.

Several times the Court has effectively avoided facing this question, as did Judge Lamberth in this case, by finding that the expression would still have been protected even if its particular commercial use deprived otherwise "pure" speech of its full First Amendment status.

Perhaps at this early stage, the most helpful analytic tool would be a strong, though rebuttable, presumption: Material such as a medical journal or textbook reprint — fully protected as speech of a high order for its scientific and educational value — could be subject to a lesser standard of First Amendment protection only if the material had become so integral a part of a selling campaign, or so fully enmeshed in "proposing a commercial transaction," that it was functionally and legally transformed. That was a far cry from the manner in which drug companies used the reprints on which this case focused. Only in the rare and remote circumstance of such a metamorphosis could the normal presumption of full protection be placed in doubt. Ordinarily the content of material such as the publications involved in this case should be dispositive — and thus treated as fully protected speech.

WLF v. Kessler, 13 F. Supp. 2d 51 (D.D.C. 1998).


Central Hudson Gas & Elec. Corp. v. Public Serv. Commın of N.Y., 447 U.S. 557 (1980).
New York Times Co. v. Sullivan, 376 U.S. 254 (1964).