Letter to Daniel O'Day, CEO of Gilead - Seeking Answers from Gilead on Remdesivir

Letter

Dear Mr. O'Day,

With FDA emergency use authorization recently granted for remdesivir, we write concerning your plans to ensure that this treatment is available and affordable to all. We salute your commitment to make a tax-subsidized donation of your existing supplies and to scale-up production to meet the global need. While these existing doses are anticipated as sufficient to treat about 140,000 patients, millions are infected with COVID-19. Even though it is neither a cure nor capable of significantly reducing the death rate, remdesivir appears to assist in reducing the recovery period for some who are hospitalized. For this limited purpose, it may eventually have a global market of millions.

Without an investment by American taxpayers, remdesivir would apparently have been abandoned. We are particularly concerned about the affordability of this treatment both because taxpayer investment made the difference and because of Gilead's troubling history including attempted misuse of orphan drug status for remdesivir, Sovaldi priced beyond the reach of some public health programs and many Hepatitis-C victims, and delay of a safer HIV drug in order to maximize monopoly profits on Truvada.

Following your statements last week, we write to better understand (1) how Gilead will secure the remdesivir supply chain, (2) what purchase and pricing arrangements Gilead is making for future supplies of remdesivir, and (3) how much public money has been invested in remdesivir's development.

To ensure the global need for therapeutics is met, we respectfully request that you provide the following information:

Securing the Supply Chain
1. How much does it cost to manufacture a single dose of remdesivir? Since current tax law permits Gilead to take a tax deduction for donated doses in the amount of twice the cost of production, what is the estimated amount of the deduction that Gilead plans to take?

2. Where are your manufacturing facilities located and what is the maximum production capacity of each and timeline for reaching full capacity?

3. What plans has Gilead made to build additional manufacturing facilities and what are the sources of any outside funding for manufacturing, including costs associated with scaling up capacity, Gilead has received?

4. Will you commit to issuing open licenses allowing other manufacturers to produce remdesivir, and if not, are you working with any generic manufacturers or contractors to scale-up supply and what are the terms of those agreements?

5. What international coordination are you arranging to ensure that doses will be available in the most affected areas and what is your plan for distributing supplies?

Purchase and Pricing Arrangements
1. What arrangements has Gilead made with governments, insurance companies, pharmacy benefit managers, or other entities regarding purchase and coverage of remdesivir?

2. What were the terms and conditions agreed upon in these contracts, including pricing?

3. Which of these arrangements include agreements to cover or provide preferential treatment to other Gilead products?

4. What supply targets and timelines for delivery are established in these arrangements?

Public Investment
With regard to research and development of remdesivir, please provide a breakdown of expenditures and sources of funding, including all investments, made directly or indirectly through grants to other institutions, by the U.S. federal government, foreign governments, and private foundations. Please include the amount of qualified research expenses related to remdesivir reported for purposes of claiming the R&D tax credit and the total taxpayer subsidy provided by this credit for remdesivir.

We appreciate your attention to these important questions to ensure every hospitalized patient who could secure some limited benefit from remdesivir can afford and access it.

Sincerely,

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