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  • The Orphan Drug Act has helped pharmaceutical industry profits grow scandalously in the United States.

    The Orphan Drug Act has helped pharmaceutical industry profits grow scandalously in the United States. | Photo: EFE

Published 26 March 2020

Gilead Sciences can now profit exclusively off the drug for seven years and could also block manufacturers from developing generic versions of the drug which might be more accessible to many patients.

As healthcare providers across the United States desperately attempt to treat a rapidly growing number of patients with COVID-19, a pharmaceutical company with ties to President Donald Trump’s task force has been granted exclusive status for a drug that was being tested to treat the virus.

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The Intercept reported on Monday that the Food and Drug Administration (FDA) granted Gilead Sciences  "orphan" drug status for 'Remdesivir,' one of several drugs being tested as potential treatments for the new coronavirus.

“The Orphan Drug Act is for a rare disease, and this is about as an extreme opposite of a rare disease you can possibly dream up,” James Love, Director of Knowledge Ecology International, a watchdog on pharmaceutical patent abuse, told The Intercept.

“They’re talking about potentially half the population of the United States,” said Love, adding that “it’s absurd that this would happen in the middle of an epidemic when everything is in short supply.”

Having secured orphan drug status, Gilead Sciences can now profit exclusively off the drug for seven years and could also block manufacturers from developing generic versions of the drug which might be more accessible to many patients.

The company can set price controls on the drug as well as benefiting from grants and tax credits, acoording to Common Dreams.

The Orphan Drug Act of 1983 was passed to ensure medications for rare diseases can be developed, and was meant to benefit companies which may not recoup their research costs after their drugs are put on the market.

In addition, the law was also reserved for drugs that treat illnesses that affect fewer than 200,000 people in the U.S. But a loophole allows drugs that treat more common illnesses to be classified as orphans if the designation is given before the disease reaches that threshold. 

"The special orphan designation," according to The Intercept as well "was given to 'remdesivir' despite hefty support by the government for the development of the drug. Gilead Sciences' remdesivir was developed with at least US$79 million in U.S. government funding." 

But the most important, the Orphan Drug Act has helped pharmaceutical industry profits soar. For example, in 2018, the median cost for a year of treatment with an orphan drug was US$98,500 compared to US$5,000 for drugs that don’t have the designation, according to Gerald Posner, author of “Pharma: Greed, Lies, and the Poisoning of America,” told to The Intercept.

So that, Gilead's rush to profit off a potentially life-saving drug in the midst of a public health and economic crisis could prove "deeply harmful" to the American people, many more of whom are expected to contract the coronavirus, said government watchdog Public Citizen.

"Remdesivir is one of relatively few medicines that may prove effective in treating COVID-19 this year," said Peter Maybarduk, director of the group's Access to Medicines program.

"The government should be urgently concerned with its affordability for citizens. Instead, the FDA has handed Gilead, one of the most profitable pharmaceutical corporations on earth, a long and entirely undeserved seven-year monopoly and, with it, the ability to charge outrageous prices to consumers."

Meanwhile, Senator and Democratic presidential candidate Bernie Sanders called the reports of profiteering by Gilead Sciences, with the support of the Trump administration, "insane and unacceptable" and demanded that treatment for the coronavirus be made free for all U.S. nationals.

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