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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
Unlocking Access: Exploring Mental Health Care Among Medicaid Managed Care Enrollees
January 23rd 2025On this episode of Managed Care Cast, we speak with the author of a study published in the January 2025 issue of The American Journal of Managed Care® to examine the association between quantitative network adequacy standards and mental health care access among adult Medicaid enrollees.
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How FcRn Blockade Targets Myasthenia Gravis Autoantibodies
January 29th 2025In part 2 of our interview with Katie Abouzahr, MD, Johnson & Johnson Innovative Medicine, we discuss the challenge inherent in treating adolescents who have the myasthenia gravis and how nipocalimab works via FcRn blockade to reduce the circulating autoantibodies that drive myasthenia gravis.
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