Special status given to COVID-19 drug, Remdesivir, causes cost and supply concerns
The US Food and Drug Administration (FDA) has granted Gilead Science "orphan" drug status for their antiviral drug, Remdesivir, causing concern over what this means for access and pricing for the promising COVID-19 treatment.
The "orphan" drug designation is intended to give pharmaceutical firms tighter controls over treatments that they develop for rare diseases. This designation by the FDA could block generic manufacturers from supplying the drug - instead handing over control over manufacturing, supply and pricing exclusively to Gilead Sciences. Gilead Sciences' stock price rocketed after the FDA's announcement.
“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,” commented James Love, Director of Knowledge Ecology International, a pharmaceutical patent abuse watchdog.
Indeed with billions of people set to become infected with SARS-CoV-2 in the next year the "orphan" drug designation seems to be odds with the global pandemic unfolding before our very eyes.
The Orphan Drug Act (1983) bestows several benefits on any company that develops drugs designed specifically for rare diseases - which traditionally aren't seen as high profit area. Benefits include: Seven years of market exclusivity on the drug and tax credits.
The market exclusivity awarded under the Orphan Drug act could lead to massively reduced availability of the drug, with generic manufacturers blocked from producing their own versions by patient laws.
Gilead Sciences have already announced that they are no longer providing 'emergency access' to remdesivir saying that they've been overwhelmed by demand are were unable to process existing requests. This came just hours before the FDA's announcement on the drug's status.
Experts are up in arms, pointing out that remdesivir was developed in part with $79,000,000 of US government funding and with research by the US Army Medical Research Institute of Infectious Disease.
This isn't the first time Gilead Sciences have been in hot water for their pricing practices. Their Hepatitis C treatment, Sovaldi, was purchased from another firm and then tripled in price.
Gilead also continue to sell HIV treatment and prevention drug, Truvada, for $2,000 a month in the US despite the fact it costs less than $10 to manufacture. The United Kingdom invalidated Gilead's attempt to extend the Truvada patent in Europe in 2018 meaning that generic manufacturers could produce the drug saving costs for health providers and patients alike.