A Low Dose Prescription: Criminal Prosecution Of Off-Label Drug Promotion

Overview

Drug company scientists discover that a rare debilitating disease may be treated with a drug licensed to treat an unrelated ailment. The Food and Drug Administration ("FDA") has not approved the drug for the rare disease. While the company begins time consuming and expensive clinical trials to test this discovery, patients with the rare disease ask their doctor for the drug. Doctors seek as much information as possible on this "off-label" use. The drug company wants to get the word out quickly about the new use.

Should a drug company be permitted to promote the drug for the new use before FDA approval, and if so, what can the company say?

Should doctors be permitted to prescribe a drug for an unapproved use, and if so, under what conditions?

If doctors can prescribe the drug, how do they obtain information on the correct dosage and adverse side effects?

Under what circumstances can a company provide "off-label" information to doctors?

The answers are unclear. Permitting a drug company to promote off-label uses results in faster and more efficient dissemination of information to doctors that in turn may save the lives of patients with certain terminal diseases1 and in relief for patients with rare diseases who often must rely upon off-label uses to treat their disease. Prohibiting off-label promotion encourages drug companies to conduct appropriate studies before promoting a drug.

Faced with these issues, the government has essentially opposed drug company promotion of off-label uses. While doctors are allowed to prescribe drugs for off-label uses, drug companies are prohibited from promoting drugs for such uses in most circumstances.2 The rationale is to protect the public from drug use that does not meet FDA standards, while protecting doctors' medical discretion to treat patients. An inherent inconsistency exists. While doctors are most knowledgeable in diagnosing their patients, drug companies are most knowledgeable about their drugs. Accordingly, the party most knowledgeable about the drug cannot explain to doctors the drug's treatment qualities, dosing regimen and adverse effects.

Nonetheless, off-label drug use is widespread. A 2004 study involving 355,409 hospitalized patients 18 years or younger showed that doctors treated almost 80% of them with at least one off-label drug. Off-Label Drug Use in Hospitalized Children, Archives of Pediatrics & Adolescent Medicine, Vol. 161, No. 3 (March 2007).3 During 1997 hearings, Senator Frist testified that off-label uses constituted 40-60% of all drug prescriptions, over 70% of all pediatric drug prescriptions, and as much as 90% of all oncology prescriptions. 143 CONG. REC. S8162-02 (daily ed. July 28, 1997). Government programs often reimburse such uses. Medicare covers off-label uses of cancer drugs if included in certain medical compendia. 42 U.S.C. ß 1395x(t)(2).

Off-label drug prescriptions have spawned criminal charges of off-label promotion by drug companies and their agents, malpractice claims against doctors who prescribed drugs for off-label uses, insurance coverage disputes for off-label drug treatments, and class action litigation by off-label drug users alleging injury. This article focuses solely upon criminal charges.

Criminal Prosecution of Off-Label Drug Promotion

Drug promotion takes many forms: sponsored educational seminars on drug uses, distribution of journal articles and reference texts discussing drug uses, and sales representative discussions with medical professionals on drug uses. Off-label drug promotion comes into play when a drug company includes off-label uses in its promotional activities.

No statute explicitly criminalizes off-label drug promotion. Prosecutors, however, have charged...

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