CORONAVIRUS: Trump Administration Must Reverse ‘Orphan Drug’ Decision

Orphan drug status intended for rare diseases, gives Big Pharma giant Gilead exclusive rights, blocks generic versions for seven years

Gilead’s former top lobbyist now top Trump advisor on Coronavirus Task Force

Gilead stock surges as market collapses

Flashback: ”HIV treatment cost taxpayers millions…[Gilead] making billions”

Washington, DC – Today, Patients Over Pharma called for an immediate reversal of the decision by the U.S. Food and Drug Administration (FDA) to grant orphan drug designation to Gilead Science’s experimental drug remdesivir for the treatment of coronavirus. The granting of this status, which is intended for “the treatment, prevention or diagnosis of a rare disease…one that affects less than 200,000 persons,” allows Gilead Sciences to claim a tax break and gives them complete exclusivity for seven years over a drug that could be used to treat millions of patients and that was developed using taxpayer-funded research.

“This is a misguided use of the Orphan Drug Act that locks up a promising potential coronavirus treatment and hands the key to a pharmaceutical company with a track record of price gouging HIV patients,” said Eli Zupnick, spokesman for Patients Over Pharma.

“There is no doubt that the number of people who will suffer from COVID-19 will surpass 200,000 very quickly, so for Gilead to scramble to apply for orphan drug status before that happens is craven even by Big Pharma’s standards, and for their request to be granted by the FDA is absurd.

“This decision should be reversed immediately and policymakers should move quickly to protect patients and public health by ensuring that coronavirus vaccines and treatments developed using taxpayer dollars are affordable and accessible to every American as quickly as possible.”

Gilead Sciences, whose former lobbyist Joe Grogan is now a top advisor of President Trump serving on the Coronavirus Task Force, has previously been sued by the government for price gouging on its HIV prevention drug.

According to a recent report from Public Citizen, the pharmaceutical industry hasn’t made significant investments in infectious diseases, including coronaviruses, while the National Institutes of Health has invested nearly $700 million on coronavirus R&D since the SARS outbreak.

Background on Grogan, Gilead Sciences, taxpayer funding, and price-gouging

Grogan Served As Top Lobbyist For Gilead, Including Work On How Much Federal Health Program Paid For Its Medicines, Immediately Prior To Joining Trump Administration. “Grogan worked as the top lobbyist for Gilead Sciences until he arrived at OMB last March, dealing with issues including how much federal health programs would pay for its medicines. Gilead was the company that in 2014 effectively set off the drug price controversy with Sovaldi, its breakthrough hepatitis C cure that cost $1,000 per pill and triggered a lengthy and highly critical Senate Finance Committee probe.” [Politico, 5/27/18]

In Response To Prior Concerns About Conflict Of Interest Due To Lobbying Work, Admin Claimed Grogan Didn’t Need A Waiver Because His Role Would Affect Industry As A Whole And Not Just Gilead. “Joe Grogan — who has sweeping authority over drug pricing, entitlement programs and other aspects of federal health policy at the Office of Management and Budget — didn’t obtain a waiver from a directive Trump issued during his first week in office that imposed a two-year cooling-off period between lobbying and regulating on the same “specific issue area.” . . . The administration says Grogan didn’t need such a waiver because his OMB job doesn’t overlap with what he did for California-based Gilead. His new role, OMB says, affects policy for an entire industry, not simply the one company he worked for.” [Politico, 5/27/18]

U.S. Government Funded Research That Led To Gilead HIV Drug Truvada – Gilead Has Fought Government Attempts To Collect Royalties Or Distribute The Drug More Widely. “Thomas Folks spent years in his U.S. Centers for Disease Control and Prevention lab developing a treatment to block deadly HIV in monkeys. Then San Francisco AIDS researcher Robert Grant, using $50 million in federal grants, proved the treatment worked in people who engaged in risky sex. Their work — almost fully funded by U.S. taxpayers — created a new use for an older prescription drug called Truvada: preventing HIV infection. But the U.S. government, which patented the treatment in 2015, is not receiving a penny for that use of the drug from Gilead Sciences, ­Truvada’s maker, which earned $3 billion in Truvada sales last year. Gilead argues that the government’s patents for Truvada for PrEP, as the prevention treatment is called, are invalid. And the government has failed to reach a deal for royalties or other concessions from the company — benefits that could be used to distribute the drug more widely.” [Washington Post, 3/26/19]

November 2019: Trump Administration Sued Gilead For Abusing Patents On HIV Drug It Developed With Taxpayer-Funded Research.“The Trump administration on Wednesday sued Gilead Sciences, a pharmaceutical company that sells H.I.V.-prevention drugs that can cost patients up to $20,000 a year, accusing the company of earning billions from research funded by taxpayers without paying taxpayers back. The government said the company infringed upon patents owned by the Department of Health and Human Services, and had refused attempts by the department to license its patents and collect royalties. The company sells two drugs, Truvada and Descovy, that can be taken once daily to prevent H.I.V. infection, a strategy called pre-exposure prophylaxis, or PrEP.” [New York Times, 11/7/19]

Gilead Priced Its HIV Drug At As Much As $20,000/Year In The U.S. “The Trump administration on Wednesday sued Gilead Sciences, a pharmaceutical company that sells H.I.V.-prevention drugs that can cost patients up to $20,000 a year, accusing the company of earning billions from research funded by taxpayers without paying taxpayers back.” [New York Times, 11/7/19]

Generic Versions Of Gilead’s HIV Drug, Truvada, Cost Roughly $60/Year In Africa – Gilead Has Sued To Prevent Efforts To Introduce A Generic In U.S. “In Africa, generic Truvada costs about $60 per patient per year. Gilead has sued companies that have tried to bring generic versions to the United States, keeping them out of the market after secret settlements.” [New York Times, 11/7/19]

Gilead CEO Defended Company’s Pricing Practices As Necessary For Research Investment, Noting It Spent $6B On HIV/AID Research Since 2000. “The chief executive of Gilead Sciences, the nation’s leading manufacturer of HIV drugs, defended the high cost of a key drug that prevents the lethal infection, telling a House committee Thursday that its hefty profits pay for continued research. “We have taken the disease from a death sentence to a manageable clinical condition, but we’re not done yet,” Gilead CEO Daniel O’Day told committee members. “We have to be sure that Americans get our medicines at a price that allows us to invest in research.’’ He said Gilead has spent $6 billion on HIV/AIDS research since 2000.” [Washington Post, 5/16/19]

Gilead’s HIV Drug, Truvada, Has Earned Them Six Times That – $36 Billion – Since 2004. “Truvada has earned Gilead about $3 billion a year and $36 billion since the drug was approved in 2004, but it is about to lose its exclusive patent protection.” [Washington Post, 5/16/19]

Headline: FiercePharma: “Pfizer, BMS, Gilead, AbbVie and others hike prices on hundreds of meds to ring in 2020.” [FiercePharma, 1/2/20]

Gilead Raised HIV Drug Prices By 4.9% For 2020; Claimed It Wouldn’t Affect Patient Access. “For its part, Gilead raised HIV drug list prices by 4.9% to “reflect the rising costs of goods and services necessary to produce groundbreaking medicine,” a spokesman said. The company doesn’t anticipate that the changes will affect patient access, and Gilead further supports access programs for HIV prevention and treatment options, he added.” [FiercePharma, 1/2/20]

Headline: CBS News: “VA can’t afford drug for veterans suffering from hepatitis C.” [CBS News, 12/1/15]

2015: Gilead Priced Hepatitis C Medication At $1,000 Per Pill – So Cost Prohibitive That Department Of Veterans Affairs Told Some Patients It Couldn’t Afford To Offer The Treatment. “On Tuesday, a Senate report found Gilead Sciences, which makes a cure for a fatal form of hepatitis, is more interested in profits than patients. The cure was invented under the leadership of a celebrated doctor in the Department of Veterans Affairs, but at $1,000 a pill, even the VA can’t afford to save the lives of veterans who need it. . . . The drug — sofosbuvir — is sold as Sovaldi and Harvoni — and claims to cure up to 99 percent of hepatitis C patients. But there’s a catch, the retail price for a 12 week treatment is $84,000. The Department of Veterans Affairs gets a 50 percent discount, but even with that the VA told Yisrael they can’t afford to give it to everyone who needs it — including him.” [CBS News, 12/1/15]

Headline: FiercePharma: “Gilead prices hepatitis C giant Sovaldi in China at one-fifth the U.S. price: report.” [FiercePharma, 11/28/17]

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