Description
The heaviest legal penalties imposed on drug companies concern interactions with healthcare professionals in the context of prescription drug marketing, notably for violations of the Anti-Kickback Statute and the False Claims Act. Monetary penalties have amounted to billions of dollars in some cases.
Payments or other transfers of value made to certain healthcare professionals or teaching hospitals must be reported to the government. In addition, company-sponsored speaking programs and detailing by sales representatives must comply with provisions of the Federal Food, Drug, and Cosmetic Act on advertising and promotion. Industry guidance urges drug companies to follow the highest ethical standards as well as all legal requirements. In this course we identify the laws and guidance that apply, and we provide information that will help companies to market their products without incurring penalties.
In companion courses on marketing of prescription drugs in the USA, we deal with the legal and regulatory framework for advertising and promotion of drugs, with general regulatory compliance in that context, and with considerations that are particular to consumer-directed advertising and online promotion.
