Objectives • New drug approval process • Pricing of new drugs • Off ...

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May 13, 2004
Under the agreement released Thursday
by federal prosecutors, Warner-Lambert
(Pfizer) acknowledged spending
hundreds of thousands of dollars to
promote non-approved uses for the
anti-seizure drug Neurontin through a
publication strategy that subsidized
production and dissemination of
anecdotal reports.
Court Rulings on Off-Label 1983
• “Once a drug product has been approved for
marketing, a physician may, in treating patients,
prescribe the drug for uses not included in the
drug’s approved labeling.” Proposed New Drug,
Antibiotic, and Biologic Drug Regulations, 48 Fed.
Reg. 26,720; 26,733 (proposed June 9, 1983).
• The FDA disclaims authority to interfere with a
doctor’s judgment to prescribe a drug for an
unapproved use. Id. See also 21 C.F.R. § 312.3(d)
(exemption from FDA regulations for “the use in the
practice of medicine for an unlabeled indication of a
new drug product approved” by the Agency”).
• The same is true for medical devices. 21 U.S.C. §
396.
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