Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs.
نویسندگان
چکیده
Professor O'Reilly's study of recent drug review legislation applies a historical and holistic view of promotion practices for unapproved uses of prescription drugs. He faults Congress for moving public health protections away from a strictly protective mode and toward assistance to drug marketers. He argues that the adverse health consequences of "off-label" promotion of drugs are not well understood, and that the 1997 amendments deserved the public health interest while expanding pharmaceutical company profits.
منابع مشابه
The Prevalence and Cost of Unapproved Uses of Top-Selling Orphan Drugs
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عنوان ژورنال:
- Annals of health law
دوره 12 2 شماره
صفحات -
تاریخ انتشار 2003