Drug Ammendments

-the first federal statue to protect citizens from harmful drugs, and it prohibited the importation of adulterated drugs

-(only for drugs that were imported from different countries)

-prohibited interstate commerce of misbranded and adulterated food, drinks, and drugs

-(did not require manufacturers to list ingredients or directions for use on the label, and it did not refer to false health claims.)

-prohibited false and 'fraudulent' label claims of therapeutic effectiveness

-prohibited marketing of a new drug until proven safe for use under the conditions described on the label and approved by the FDA.

-marked the beginning of the approval process

- "nucleus of today's laws"

Which act authorized: factory inspections, cosmetics, medical devices?

(hint: it exempted the drugs marketed before 1938 from drug approval process)

-required that drugs that cannot be safely used without medical supervision be dispensed only be prescription of a licensed practitioner.

-drug marketed in West Germany as sleep-inducing agent

-became marked as anti-nauseant for pregnancy

-never marketed in US because of Federal Food, Drug, and Cosmetics Act of 1938

*Dr. Frances Kelsey

-drugs had to be safe & effective

disease that affects fewer than 200,000 people

-this act passed to provide a 50% tax off human trials for manufacturers to develop and market drugs or biologicals for the treatment of 'rare diseases'

-generic drug companies did not have to perform clinical trials, but rather perform bioequivalence studies

-pharmaceutical manufacturers required to provide rebates (best price) to Medicaid

-government sponsored demonstration projects relating to the provision of pharmaceutical services

-mandatory DUR (prospective and retrospective), including patient counseling, for Medicaid recipients

led to the creation of Medicare part D