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Gilead Sciences, a major pharmaceutical company with total revenues of $22.4 billion in 2019,[1] in March greedily sought to profiteer off of the catastrophic coronavirus (COVID-19) pandemic by seeking and receiving a lucrative orphan drug designation from the Food and Drug Administration (FDA) for an experimental drug being tested as a treatment for COVID-19.[2] The drug, known as remdesivir, was originally developed by Gilead several years ago as a potential treatment for the deadly...
Gilead Sciences, a major pharmaceutical company with total revenues of $22.4 billion in 2019,[1] in March greedily sought to profiteer off of the catastrophic coronavirus (COVID-19) pandemic by seeking and receiving a lucrative orphan drug designation from the Food and Drug Administration (FDA) for an experimental drug being tested as a treatment for COVID-19.[2] The drug, known as remdesivir, was originally developed by Gilead several years ago as a potential treatment for the deadly viral disease Ebola.
The orphan drug designation is intended to encourage the development of treatments for rare diseases or conditions, which are defined as diseases or conditions affecting 200,000 or fewer people in the U.S. An orphan drug designation provides a company with substantial tax breaks related to the development of the product and, more importantly, two additional years of marketing exclusivity — allowing a company to charge exorbitant monopoly prices for a much longer period.
The FDA granted Gilead the orphan drug designation for remdesivir on March 23.[3] On that day, the number of confirmed coronavirus cases in the U.S. had reached 53,000,[4] but at that time, the count was expected to exceed 200,000 by the end of March and eventually reach tens of millions or more.
FDA rules allow the agency to grant orphan drug status to a medication based on the number of people who have the targeted disease or condition at the time a company applies for this designation. Thus, in the case of remdesivir, Gilead — despite knowing that COVID-19 would eventually strike tens of millions of people in the U.S. — obviously rushed to file its orphan drug application with the FDA before the case count exceeded 200,000.
The company clearly aimed to exploit the orphan drug provision as a vehicle to better cash in on the COVID-19 crisis, rather than as a means to develop a remedy for a truly rare disease.
In response to this unconscionable abuse of the orphan drug program, Public Citizen and 50 other organizations on March 25 wrote to Daniel O’Day, the CEO of Gilead, and demanded that he reverse course and renounce his company’s claim to the orphan drug designation for remdesivir.[5] In their letter to O’Day, the organizations said, “Calling COVID19 a rare disease mocks people’s suffering and exploits a loophole in the law to profiteer off a deadly pandemic. Making the claim to special orphan status even more outrageous is the fact that the public already has largely paid for remdesivir’s development.”[6]
Having been publicly shamed, Gilead on March 25 announced that it had asked the FDA to rescind the orphan drug status for remdesivir.[7] In the future, the federal government must ensure that Big Pharma’s insatiable appetite for unjustified profits does not become an impediment to ending the coronavirus pandemic.
References
[1] Gilead. Press releases: Gilead Sciences announces fourth quarter and full year 2019 financial results. February 4, 2020. https://www.gilead.com/news-and-press/press-room/press-releases/2020/2/gilead-sciences-announces-fourth-quarter-and-full-year-2019-financial-results. Accessed April 6, 2020.
[2] Lupkin S. FDA grants experimental coronavirus drug benefits for rare disease treatments. NPR. March 24, 2020. https://www.npr.org/sections/health-shots/2020/03/24/821035311/fda-grants-experimental-coronavirus-drug-benefits-for-rare-disease-treatments. Accessed April 6, 2020.
[3] Public Citizen. Gilead outrageously seeks super-monopoly protections for Covid-19 Drug: Statement of Peter Maybarduk, Director, Public Citizen’s Access to Medicines Program. March 23, 2020. https://www.citizen.org/news/gilead-outrageously-seeks-super-monopoly-protections-for-covid-19-drug/. Accessed April 6, 2020.
[4] Johns Hopkins University and Medicine. Coronavirus COVID-19 global cases by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU). https://coronavirus.jhu.edu/map.html. Accessed April 6, 2020.
[5] Public Citizen. Gilead must relinquish monopoly on potential coronavirus treatment: 51 groups warn Gilead against profiteering off the pandemic. March 25, 2020. https://www.citizen.org/news/gilead-must-relinquish-monopoly-on-potential-coronavirus-treatment/. Accessed April 6, 2020.
[6] Letter to Daniel O’Day, Gilead Sciences. March 25, 2020. https://www.citizen.org/wp-content/uploads/Letter-from-50-groups-to-Gilead-renounce-remdesivir-orphan-drug-claim.pdf. Accessed April 6, 2020.
[7] Thomas K. Gilead withdraws request for special orphan status on experimental virus treatment. The New York Times. March 25, 2020. https://www.nytimes.com/2020/03/25/health/gilead-coronavirus-orphan-drug.html. Accessed April 6, 2020.
