In This Issue:

- Orphan Drug Rule Background

- PhRMA Sues to Block the Orphan Drug Rule

- District Court Says HHS Overstepped Its Authority and Invalidates Orphan Drug Rule

- Implications on the “Mega-Reg”

- HHS’s Next Steps

- Industry Reactions

- Excerpt from Orphan Drug Rule Background:

The Affordable Care Act extended participation in the 340B Program to critical access hospitals, rural referral centers, sole community hospitals, freestanding cancer hospitals and children’s hospitals. Congress recognized that providing 340B Program discounts on all outpatient drugs purchased by these newly eligible entities could adversely affect the desire and ability of pharmaceutical manufacturers to develop orphan drugs. Generally, orphan drugs are developed to treat rare diseases or conditions that affect fewer than 200,000 people. Congress balanced its desire to extend the benefits of the 340B Program to these newly eligible entities against its concern for stymieing the development of orphan drugs by denying 340B Program pricing to certain of these newly eligible entities for drugs “designated by the Secretary under section 526 of the Federal Food, Drug and Cosmetic Act for a rare disease or condition.”