When medications are developed by pharmaceutical companies to treat certain symptoms, sometimes the drugs which are created can be used for a completely different purpose than what they were originally approved for. The pharmaceutical companies who create such drugs have an economic interest in promoting such off-label prescription usage in patients.  In November 1998, the Food and Drug Administration enacted the Food and Drug Administration Modernization Act in an attempt to regulate the dissemination of off-label prescription use literature. The Washington Legal Foundation challenged the constitutionality of the Act in the United States District Court for the District of Columbia on the grounds it that interfered with the pharmaceutical companies’ right to free speech.     

                Prior to the enactment of the FDA Modernization Act, the FDA had published three Guidance Documents to regulate the dissemination of off-label drug use information.  After the District Court held that the policies set forth in the Guidance Documents interfered with the right to free speech, the FDA enacted the FDA Modernization Act, which modified the polices set forth in the Guidance Documents. 

                The Act allowed drug companies to disseminate journal articles and reference medical texts regarding off-label prescription usage under very limited circumstances.  The drug referenced in the articles had to be the subject of an approved application or otherwise lawfully marketed.  The information could not be false or misleading or published without permission.  Prior to disseminating the information, an advance copy had to be sent to the FDA along with any clinical trial information and reports of clinical experiences.  The manufacturer had to submit or agree to submit a supplemental new drug application for the off-label use.  The information circulated by the drug company had to provide certain disclosures including:  (1) that the material was discussing off-label use not approved by the FDA; (2) that the material was being sent at the manufacturers’ expense; (3) that the authors of the information have financial interests in the information; (4) that the product had been currently approved for certain uses only; (5) the identity of the persons who were funding the off-label usage study; and, (6) a bibliography of other scientific articles discussing off-label use. Finally, the manufacturer was required to submit to the FDA on a semi-annual basis reports regarding what information had been disseminated and to whom.

                The plaintiff objected to the regulations as unconstitutional and argued that the Act was inconsistent with the Court’s prior ruling regarding the Guidance Documents.  In determining whether the Act interfered with the manufacturer’s rights to free speech, the Court looked at whether the speech at issue was in anyway false or misleading.  The Court pointed out that the First Amendment is based upon the notion that people do not need government permission to engage in truthful, non-misleading speech about lawful activities. Therefore, the FDA was required to show that it had a substantial governmental interest in regulating the dissemination of off-label use information unless it could show that such information was false or misleading.   

                The FDA argued that the information at issue was likely to be misleading because manufacturers have an economic incentive for distributing only positive information and omitting any negative information.  However, the FDA failed to show that overall the information was more likely to mislead than inform. In particular, the Court explained that the recipients of the information to be regulated were physicians with extensive knowledge about how to use the information.  Since the Court found that the information was not inherently misleading, the FDA had to demonstrate that it had a substantial governmental interest to regulate the information. 

                The FDA claimed it had two legitimate governmental interests to promote which included ensuring that the physicians receive accurate information about the off-label prescription use and encouraging drug companies to seek approval for such off-label uses. The FDA claimed that both of these interests derived from its overall interest in protecting and promoting public health.  The Court was not persuaded that the FDA’s interests justified the restrictions. Although the Court agreed that the FDA had a substantial governmental interest in encouraging manufacturer’s to seek approval of off-label uses, the Court held that the regulations imposed were more burdensome than necessary to promote this interest.  Therefore, the Court found that the FDA’s Modernization Act was unconstitutional and rendered it unenforceable.   

                In light of the Court’s decision, a physician should be careful when suggesting off-label usage of prescriptions for a patient.  Since this area is not heavily regulated by the government, a doctor needs to be fully aware of the potential side effects of off-label uses. A physician should not rely solely on the medical literature provided by the manufacturer of a prescription drug when making the decision as to whether to suggest an off-label use to a patient. A physician should provide a patient with as much information as possible about the off-label use.  More importantly, a physician should make sure the patient comprehends that the FDA has not approved the drug for the purpose which the doctor has prescribed it.


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    Communications with Drug Companies

    by Attorney Frank E. Reardon

    September 1999

    REARDON LAW OFFICE