Journal-based CME Course: Should a Law Governing the Pharmaceutical Market Be Ethically Examined Based on Its Intent or Its Practical Applications?

Activity ID

10772

Expires

July 31, 2025

Format Type

Journal-based

CME Credit

Fee

$30

CME Provider: AMA Journal of Ethics

Description of CME Course

Prescription drug prices are a top health care concern among US consumers. Although this issue is at the forefront of current policy discussions, it is not new. In 1984, the Drug Pricing Competition and Patent Term Restoration Act (colloquially, the Hatch-Waxman Act) addressed drug pricing concerns. This article argues that Hatch-Waxman properly applies utilitarian principles to complex issues of biopharmaceutical development by balancing innovation and availability. However, the statute’s efficacy has been marred by so-called pay-for-delay arrangements, which disrupted that carefully constructed equilibrium. This article also argues that the 2013 US Supreme Court holding in Federal Trade Commission v Actavis, Inc appropriately restored the utilitarian balance initially achieved by Hatch-Waxman.

Disclaimers

1. This activity is accredited by the American Medical Association.
2. This activity is free to AMA members.

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More Information

Commercial Support?

NOTE: If a Member Board has not deemed this activity for MOC approval as an accredited CME activity, this activity may count toward an ABMS Member Board’s general CME requirement. Please refer directly to your Member Board’s MOC Part II Lifelong Learning and Self-Assessment Program Requirements.

General Information on CME Activity

Educational Objectives

1. Explain a new or unfamiliar viewpoint on a topic of ethical or professional conduct
2. Evaluate the usefulness of this information for healthcare practice, teaching, or conduct
3. Decide whether and when to apply the new information to healthcare practice, teaching, or conduct

Keywords

Ethics, Law and Medicine, Health Care Economics, Insurance, Payment, Pharmacoeconomics

Competencies

Medical Knowledge, Professionalism

CME Credit Type

AMA PRA Category 1 Credit

DOI

10.1001/amajethics.2019.661