Rare diseases affect over 25 million individuals in the United States and have historically lacked pharmaceutical development attention due to decreased potential for profit. The Food and Drug Administration (FDA) qualifies a rare disease as one which affects fewer than 200,000 people, or as a condition that affects greater than 200,00 persons in the United States but for which there is no reasonable expectation that pharmaceutical companies will recover the costs incurred during drug development following pharmaceutical sales. The Orphan Drug Approval Law of 1983 incentivized pharmaceutical companies to develop drugs for rare diseases by offering market exclusivity and tax credits. This activity reviews the history of the Orphan Drug Approval Law and discusses associated ethical concerns and clinical significance.
- Provider:StatPearls, LLC
- Activity Link: https://www.statpearls.com/ArticleLibrary/viewarticle/131543
- Start Date: 2023-09-01 05:00:00
- End Date: 2023-09-01 05:00:00
- Credit Details: AMA PRA Category 1 Credit™️: 1.0 hours
Nursing: 1.0 hours
Pharmacy: 1.0 hours - MOC Credit Details: ABS - 1.0 Point; Credit Type(s): Accredited CME (ABS)
ABOS - 1.0 Point; Credit Type(s): Accredited CME (ABOS)
ABPATH - 1.0 Point; Credit Type(s): Lifelong Learning (ABPATH)
ABTS - 1.0 Point; Credit Type(s): Accredited CME (ABTS)
ABIM - 1.0 Point; Credit Type(s): Medical Knowledge (ABIM)
ABS - 1.0 Point; Credit Type(s): Self-Assessment (ABS)
ABP - 1.0 Point; Credit Type(s): Lifelong Learning and Self-Assessment (ABP)
ABOHNS - 1.0 Point; Credit Type(s): Self-Assessment (ABOHNS)
ABTS - 1.0 Point; Credit Type(s): Self-Assessment (ABTS) - Commercial Support: No
- Activity Type: Enduring Material
- CME Finder Type: Online Learning
- Fee to Participate: Variable
- Measured Outcome: Learner Knowledge, Learner/Team Competence
- Provider Ship: Directly Provided
- Registration: Open to all
- Specialty: Adult Cardiac, All Practice Areas (e.g. ethics), Cardiothoracic, Cardiovascular, Congenital Cardiac, Critical Care, General Orthopaedics, General Otolaryngology, General Pediatrics, General Surgery, General Thoracic, Internal Medicine, Non-Thoracic Surgery