Upjohn v. Finch

Upjohn V Finch upholds enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy. FDA requires the first patient package insert. 

As it had argued successfully in Upjohn v. Finch, the FDA needed something more scientific than personal accounts from patients and physicians to validate a drug s effectiveness. Informal evaluation by patients and doctors is subject to placebo effects (placebo is Latin for I will please ). Originally, a placebo referred to a harmless substance given to please a patient complaining about symptoms that otherwise could not be treated. The belief of the... 

The Supreme Court rules in Upjohn v. Finch that the FDA properly removed Panalba and other similar antibiotic drugs from the market because of a lack of scientific evidence of their effectiveness and that past use by doctors and patients does not demonstrate the drugs work as purported. The FDA requires a PPI for birth control pills, first approved for public use in 1960. 

---