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The Orphan Drug Act: Does it Help or Hurt?
Introduced with good intent, some of the provisions of the Orphan Drug Act may compel the FDA to rethink its strategy.
The Orphan Drug Act, introduced by the FDA in 1983 was intended to treat conditions affecting less than 200,000 patients per year. Since drug developers would not profit from investing in drug programs intended for such a small section of the population, the FDA hoped to provide incentives to the pharmaceutical industry through this Act. Although well-intended, the outcomes may not be those intended by the drug regulatory authority.
Orphan drugs can be very high priced, and they also come with a 7-year marketing exclusivity, which kills competition for the manufacturer. They are also exempt of the branded prescription drug fee levied through provisions of the Affordable Care Act. Taken together, these incentives may be distorting the original intent of the Act.
Read more at Pharmaceutical Online: http://bit.ly/1FDsLXD
AI in Health Care: Balancing Governance, Innovation, and Trust
September 2nd 2025In this conversation with Reuben Daniel, associate vice president of artificial intelligence at UPMC Health Plan, we dive into how UPMC Health Plan builds trust with providers and members, discuss challenges of scaling AI effectively, and hear about concrete examples of AI's positive impact.
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Infertility Coverage Boosts ART Use and Pregnancy Success: Richard A. Brook, MS, MBA
August 26th 2025In this episode, Richard A. Brook, MS, MBA, discusses his study showing that infertility treatment coverage increases assisted reproductive technology (ART) use and improves pregnancy outcomes.
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Health Care Utilization and Cost of Diagnostic Testing for Respiratory Infections
September 17th 2025Syndromic reverse transcriptase–polymerase chain reaction tests for respiratory infections were associated with lower health care resource utilization and costs, implicating potential for improved value in patient care.
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Cumulative Atropine Not Associated With Increased Risk of Ocular Events in Children With Myopia
September 17th 2025Although children living with myopia taking atropine did experience an increased incidence of cataracts, glaucoma, or maculopathy, it is unclear if this risk was confounded by myopia severity.
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