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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
Oncology Onward: A Conversation With Thyme Care CEO and Cofounder Robin Shah
October 2nd 2023Robin Shah, CEO of Thyme Care, which he founded in 2020 with Bobby Green, MD, president and chief medical officer, joins hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, to discuss his evolution as an entrepreneur in oncology care innovation and his goal of positively changing how patients experience the cancer system.
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Survival, PROs Favor Cemiplimab Plus Chemotherapy vs Chemotherapy Alone in Advanced NSCLC
December 4th 2023For patients with advanced non–small cell lung cancer (NSCLC), regardless of PD-L1 status, cemiplimab plus chemotherapy had favorable survival benefits and patient-reported outcomes over chemotherapy alone.
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SABCS 2023 Sessions Touch on "Every Aspect of Breast Cancer"
December 4th 2023The 46th annual San Antonio Breast Cancer Symposium will take place December 5-9, with new and experienced attendees able to choose and learn from a schedule overflowing with the latest developments in breast cancer science and research.
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