The Food and Drug Administration oversees strict requirements on pharmaceutical suppliers who are obligated to include adequate directions for use of the inherently dangerous prescription medications they market in the United States. Those directions must include data on indications, dosage, and the hazards of use, which is directed to the prescribing physician as the learned intermediary between the manufacturer and the consumer. Martin v. Hacker, 83 N.Y.2d 1 (1993).

The information is published and accompanies the product in the form of a package insert, the content of which requires FDA approval. The extent to which this information is relevant in the determination of malpractice claims against those prescribing the products is a source of interest which has been addressed on the federal level and in the state courts over the past 60 years.