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After Caving on ‘Orphan Drug’ Designation, Gilead Must Commit to Licensing and Mass Production

Statement of Peter Maybarduk, Director, Public Citizen’s Access to Medicines Program

WASHINGTON - Shortly after Public Citizen and 50 groups demanded that Gilead Sciences relinquish its government-sanctioned monopoly guarantee for a potential COVID-19 treatment, the pharmaceutical giant agreed to do so.

It was outrageous that Gilead ever sought an “orphan drug” designation for remdesivir, which aims to treat a patient population that easily may number in the tens of millions in the U.S. alone. That designation would confer a special seven-year monopoly on the drug. Thankfully, under pressure, the company has backed down. There’s no doubt that the prospect of an enormous public backlash is what made the difference.

But today’s action is not enough. If remdesivir proves to be a viable treatment for COVID-19, then the world cannot afford to have one manufacturer maintain a monopoly over it, particularly given the huge amount of public investment that has gone into the drug. Gilead must do more than make vague promises of reasonable pricing. It should commit right now to license the right and needed know-how to manufacture remdesivir to all qualified producers, in exchange for a modest royalty.

If the drug proves viable as a COVID-19 treatment, the U.S. and the world will need the product available at a low price that reflects both the public health need and the potentially enormous market – with production at an unprecedented scale.

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Public Citizen is a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in Congress, the executive branch and the courts.

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