KEY POINTS

  • FDA granted “orphan” drug status to Gilead Sciences' experimental drug Remdesivir
  • Experts believe the move could block other generic drug manufacturers from supplying antiviral drugs
  • The company said it was temporarily putting a hold on granting emergency access to the drug “due to an exponential increase” in requests

Remdesivir, an experimental drug manufactured by Gilead Sciences Inc, received the status of “orphan” drug from the Food and Drug Administration on Monday. The drug is being tested as a possible treatment for the coronavirus.

The 1983 Orphan Drug Act allows a seven-year market exclusivity period for pharmaceutical companies developing treatments for a “rare disease.” Apart from that, it also provides tax credits. Experts believe that this distinction would be beneficial for Gilead Sciences Inc as it could block other generic drug manufacturers from supplying antiviral drugs. Since the distinction allows the company exclusive protection over the drug, it could result in limited supply of the drug.

James Love, the director of Knowledge Ecology International, a non-governmental organization that deals with pharmaceutical patent abuse, said, “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. They’re talking about potentially half the population of the United States. It is absurd that this would happen in the middle of an epidemic when everything is in short supply.”

On Sunday, the company said it was temporarily putting a hold on granting emergency access to the drug “due to an exponential increase” in requests.

The company stated that the spike in coronavirus cases has “flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic.”

Gilead Sciences Remdesivir, an antiviral drug from Gilead Sciences, Inc. Photo: Reuters