Gilead Sciences is facing blowback today, following what many viewed as a bid to corner the market on a promising treatment for COVID-19, the pandemic virus now rampaging across the globe.
Gilead’s investigational antiviral drug remdesivir has shown promise against the novel coronavirus. The potential treatment is now being studied in five large clinical trials, two of which could have results ready in April.
But on Monday, the U.S Food & Drug Administration (FDA) granted remdesivir “orphan drug” status, a designation that would give Gilead a 7-year marketing monopoly on the medication during which no generic options could be made available.
Gilead requested the orphan drug status in early March, asserting it was needed to avoid FDA requirements for a pediatric study plan – a stipulation that would delay approval for more than 200 days. But critics worried that the marketing exclusivity conferred on remdesivir would allow Gilead to price gouge.
They also noted that Joe Grogan, a member of President Donald Trump’s coronavirus task force, was a lobbyist for Gilead from 2011 to 2017. During his tenure with the company, he often worked on issues related to drug pricing.
“It is insane and unacceptable that the Trump Administration has given the Gilead pharmaceutical corporation a seven-year monopoly on a potential coronavirus treatment,” Senator Bernie Sanders tweeted in reaction.
“We will not tolerate profiteering,” he continued. “Any treatment or vaccine must be made free for all.”
The pushback apparently worked, as Gilead asked the FDA to rescind remdesivir’s orphan drug status yesterday.
“Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation,” the company said. “Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited.”
This isn’t the first time Gilead has been accused of trying to gain a monopoly on potentially life-saving treatments. In fact, the federal government recently sued the company over its handling of patents for Truvada and Descovy, the only medications currently approved for pre-exposure prophylaxis (PrEP) to prevent the transmission of HIV.
In the meantime, Gilead is facing a growing number of lawsuits for allegedly failing to warn patients about the serious side effects – kidney and bone toxicity – associated with Truvada and other tenofovir disoproxil fumarate (TDF) based HIV medications. These lawsuits also accuse the company of stalling the development of safer alternatives in order to preserve the enormous profits derived from its TDF HIV drug patents.