Pfizer Lawyer Questions Off-Label Restrictions

By Jim Edwards

NEW YORK -- A top lawyer at Pfizer last week took the unusual position of publicly endorsing the right of drug companies to practice off-label marketing in certain instances.

Arnold Friede, senior counsel at Pfizer, said pharma firms should be able to distribute information on unapproved drug uses if the information is "truthful and not misleading," and published in a medical journal.

Friede's comments, at the Assn. of National Advertisers' Advertising Law Conference in New York, were notable for a few reasons. The Food and Drug Administration regards unapproved, or "off-label," promotion, as illegal. And in recent years several companies—including Pfizer—have settled with the U.S. Department of Justice for hundreds of millions of dollars to end probes of off-label promotion.

However, the federal courts have given confusing rulings on whether the FDA's reading of the law as it relates specifically to medical journals is correct. Most companies, including Pfizer, have taken a cautious approach, avoiding any kind of off-label promotion.

Medical journals often publish studies showing drugs can be used effectively for off-label purposes. And studies are extremely influential with doctors; any company that is able to point in its ads to a positive study of an approved use enjoys leverage over its rivals. But any company caught touting a study of off-label use faces the wrath of the FDA and plaintiffs' lawyers who seek to sue companies if patients become sick from drug side effects.

Friede said he believed drug companies have the right to disseminate to doctors peer-reviewed journal articles in which off-label uses of drugs are discussed. "In terms of truthful, not misleading speech, [the FDA] has a limited ability to regulate that," Friede said. He added that his position was akin to that of the Washington Legal Foundation, a right-leaning legal think-tank, which has been pushing the FDA to allow off-label promotion via journal articles for years. Of the WLF, Friede said, "I'm very close to them."

In his speech at the conference, Friede said, "Peer reviewed journals would be eligible for . . . free speech protection" under a court ruling in which the WLF had sued the FDA.

The ruling was later reversed on a procedural technicality, leaving lawyers unclear about what weight it carries. Friede said Pfizer had a policy of not distributing journal articles about off-label uses. "Pfizer decided there was so much risk in off-label communications, particularly journals," he said.

Friede's position—that drug companies should face fewer regulatory burdens on their promotional activities—is not that surprising. But his on-the-record confirmation of it, and his kinship with the WLF, is. The WLF has previously styled itself as a coalition of "doctors and medical patients who wish to receive information about off-label uses of FDA-approved drugs."

Drug companies fear challenging the FDA when they disagree with its guidance on drug promotion, Friede said, because "given the fact [the FDA also has] control over most drug approvals, most companies will not fight to the death."

The perception in the industry is that the FDA "might exercise that lever" with a drug company that opposed it over the off-label issue, Friede said.

The WLF's chief counsel, Richard Samp, said something similar. Drug companies don't officially support the WLF because "people whose livelihoods are dependent on various regulatory approvals . . . don't want to have any direct involvement with groups like us that regularly challenge the FDA," Samp told Brandweek. "But given that drug companies are very upset by the many criminal prosecutions that are going on right now about the promotion of their products, it obviously would be very much in their self-interest to have their First Amendment rights expanded."

A Pfizer rep said Friede did not endorse the WLF on any other issue, and that the company has not sought to act on the ruling in the WLF case.