On Monday, the pharmaceutical giant Gilead Sciences registered remdesivir, its antiviral medication, as an orphan drug with the FDA. The designation can lead to the pharmaceutical company being able to profit exclusively for seven years from the product, which is one of dozens being tested as a possible treatment for COVID-19.
Experts warn that this could block supplies of the antiviral medication from generic drug manufacturers and provide a lucrative outcome for Gilead Sciences, which maintains close ties with President Donald Trump’s task force for controlling the virus.
Trump, just earlier this month, attempted to buy out a German research facility that was close to creating such a drug. His intention, ever the businessman, was to secure treatment for the U.S. only. Joe Grogan, who also serves on the coronavirus task force, lobbied for Gilead from 2011 to 2017 on issues including the pricing of pharmaceuticals.
Congress created the orphan drug program over 35 years ago to encourage companies to develop drugs for rare diseases and conditions that might not otherwise be profitable. But since then, filing for orphan status has become a standard pharmaceutical industry tactic to extend the profitability of drugs and block competitors.
The FDA defines a rare disease as one with fewer than 200,000 patients in the U.S. In a statement Tuesday, the agency said COVID-19 fit that criteria when the request was made. However, there are more than 30,000 cases in New York alone with many more expected in the coming weeks and months.
“It seems like a misuse of the Orphan Drug Act, even though technically, it’s within the bounds of the law,” said Dr. Aaron Kesselheim, a Harvard Medical School health policy expert. “There’s no expectation here that this drug wouldn’t be able to generate appropriate revenue for the manufacturer.”
This same mistreatment of the orphan program was abused by drug companies in the 1980s and 1990s during the AIDs epidemic in order to generate billions of dollars in profits. Dr. Kesslheim was not the only person to express outrage at Gilead’s proposal.
“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,” said James Love, director of Knowledge Ecology International, a watchdog on pharmaceutical patent abuse. “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 a pandemic when everything is in short supply.”
Earlier this week, Gilead abruptly announced that it would no longer provide emergency access to remdesivir, telling the New York Times that “overwhelming demand” left it unable to process requests for the drug through its compassionate use program. Hours later, the FDA gave the drug orphan status. Almost immediately, Gilead’s stock price shot up. Gilead did not immediately respond to a request for comment. The White House, on behalf of Grogan, declined to comment on the record.
Since then, Gilead has backpedaled on this request due to the overwhelmingly negative response they have received. Experts and advocates went after them for the move.
“COVID-19 is anything but a rare disease,” a letter sent asking the company to comply last week explained.
Gilead explained today that they have asked the FDA to rescind the orphan drug designation and that the company “recognizes the urgent public health needs posed by the COVID-19 pandemic.”
Whether or not a more stable COVID treatment from Gilead will resurface remains to be seen, but stopping a monopoly on the drug is definitely a step in the right direction.