CAPA Statement on Gilead’s Decision to End Orphan Drug Status on COVID-19 Drug

“We Need More Competition And Not Less To Address This Pandemic”

WASHINGTON, D.C. – The Coalition Against Patent Abuse (CAPA) released the following statement regarding today’s announcement by Gilead that it is withdrawing its request for extended monopoly rights on potential Covid-19 treatment remdesivir and will ask the FDA to revoke the drug’s special “orphan drug” status.  The following can be attributed to CAPA Executive Director Matthew Lane:

“With the rapid growth and threat of COVID-19 here in the United States, special orphan status should not have been granted to this drug in the first place.  Nonetheless, we are pleased to see that under growing public pressure the last 24 hours, Gilead has withdrawn its request for orphan drug status. 

“As with many major drugs, the American people have already contributed tens of millions of dollars in grants to help support remdesivir’s development.  Further, public agencies such as the National Institutes of Health (NIH) and the World Health Organization (WHO) have already begun sponsoring clinical trials for its use as a potential COVID-19 treatment. 

“This situation highlights that while there will always be a critical need for continued innovation and public-private partnerships to develop medicines, we must still be vigilant against corporations claiming more than their fair share.  We applaud Gilead’s decision to do the right thing and rescind its orphan drug status.”


A 2019 study conducted by America’s Health Insurance Plans (AHIP), found prices on drugs with orphan status increased by 2,517 percent over a 20-year period.  The analysis also found orphan drugs are 25 times more expensive than prescription drugs without the designation.

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