In the Press
March 25, 2020

Orphan Drug Designation For Remdesivir Is 'Consistent' With Precedent, Former FDA Lawyer Says (Pink Sheet)


The lawyer who drafted Orphan Drug Act implementing regs says companies need incentive to develop a treatment that may not be available until crisis passes; KEI is mulling citizen petition to request revocation of the designation for Gilead's investigational COVID-19 product. Alexander Varond, a senior associate in Goodwin’s Technology and Life Sciences groups, said a major hurdle for pandemic products is that many, such as vaccines, would be for prevention and likely would not qualify for orphan drug designation because of the large number who would be vaccinated. Read the article in Pink Sheet here.