My Note, Bound Guidance: FDA Rulemaking for Off-Label Pharmaceutical Drug Marketing, has recently been published in volume 60 of the Case Western Reserve Law Review, pages 531-558. The Note discusses an FDA guidance document that establishes when pharmaceutical companies can provide doctors with reprints of journal articles promoting off-label uses of their drugs. It considers both the regulatory framework authorizing the FDA’s guidance, and the First Amendment rights triggered by the FDA’s attempt to restrict a company’s commercial speech.
Allowing doctors the freedom to prescribe drugs for a use other than the narrow purpose initially authorized by the FDA can unquestionably save lives. However, it is also essential to ensure that doctors have the information they need to make an informed decision before prescribing a drug for a purpose for which it was not originally intended.
Click here to download the Note.