WLF Suit Challenges Restrictions on Medical Textbooks

By Daniel E. Troy

A pending First Amendment challenge to the Food and Drug Administration's restrictions on speech concerning so-called "off-label" uses of prescription drugs and medical devices is moving into higher gear.

In late November, the Washington Legal Foundation, a public interest law and policy center, asked a federal trial court to strike down FDA restrictions that bar manufacturers from helping to disseminate professional articles, textbooks, and presentations addressing uses for their products that the agency has not approved -- even though the speech originated with scientists or doctors who have no financial ties to the manufacturer.

WLF filed suit in 1994 against the FDA prohibition on manufacturer support for independently generated publications and seminars. The agency fought back initially on procedural grounds; among other arguments, it contended that the challenged matters were not "ripe" for review because the restrictions had not been formally adopted.

The judge ordered the suit to proceed, noting that FDA officials had been warning manufacturers as early as 1991 to "put their advertising and promotional houses in order" in accordance with the FDA's proposals -- while also telling the court that the agency needed more years to deliberate before taking final action on the restrictions. The court found that the facts bolstered WLF's contention that the FDA was using its power to "implement de facto regulatory policies without formally adopting final agency positions."

In depositions taken since that time, various FDA officials have conceded that physicians should have as much information as possible about off-label uses that may benefit patients. They also admit that the agency enforcement action turns only on whether manufacturer support for distribution is involved, not on the validity of the underlying speech itself.

WLF is asking the court to rule soon on the merits of the case. The FDA's apparent rationale for its restrictions -- the supposed possibility that some manufacturer communications on off-label uses might be unsupported or untruthful and thereby lead to potentially unwise treatment decisions -- cannot justify a ban that deprives physicians of vast amounts of truthful information that would otherwise be available.

WLF asserts that any legitimate government interest in regulating this scientific speech can be addressed through far less restrictive regulations, such as requiring that the speech be subject to independent peer review or analogous scrutiny, that manufacturer support for the dissemination be disclosed, or that the off-label status of the uses be acknowledged.

Mr. Troy represents WLF in its challenge to the FDA off-label restrictions.

The FDA and Off-Label Uses of Drugs and Devices


By Daniel E. Troy

The FDA imposes sweeping restraints on speech under its limited statutory authority to require pre-marketing approval of new drugs and certain medical devices. Labels accompanying the products list only those uses approved by the FDA, and authorized marketing by manufacturers is limited to those uses.

The FDA does not, however, have power to control how doctors use the products once they pass the agency's initial review. Physicians may -- and frequently do -- prescribe drugs or use devices in ways not set forth on the FDA-approved label.

These off-label uses are particularly prominent in oncology, where medical advancements often outpace the FDA approval process, and in pediatrics, where it can be difficult to enroll sufficient numbers of children in the controlled studies necessary for FDA approval.

For some illnesses, off-label uses may be so prevalent that they are not simply a complementary treatment but actually constitute the medical standard of care. A substantial body of medical and scientific literature has developed around off-label uses, including articles in peer-reviewed professional journals, references in medical textbooks, and discussions and workshops at medical symposia.

Because the information is not available from product labels, sources like professional articles, textbooks, and symposia are crucial in providing doctors with up-to-date data about off-label uses of the drugs and devices.

This speech is not restricted -- until pharmaceutical or device manufacturers enter the discussion. The FDA generally bars pharmaceutical and device manufacturers from communicating with physicians and other health care professionals about off-label uses.

The agency's ban extends even to manufacturer-funded distribution of independently written and edited articles and books (so-called "enduring materials") and manufacturer support for independently organized symposia (such as continuing medical education seminars, or "CME") where off-label uses are discussed.