• Editor-in-Chief

Gilead Receives Backlash Over Special Status For The Drug Remdesivir After The FDA Award

By: Kelly J.

Gilead Sciences asked the U.S. Food and Drug Administration (FDA) to rescind the “orphan drug” status as they are behind the implied COVID-19 treatment named Remdesivir. Gilead requested the FDA reclassify the label they produced against their investigational antiviral treatment. Remdesivir is currently enduring clinical trials as a presumable treatment for COVID-19. 

The term "orphan drug" is a standard classification the FDA uses to list drugs and biologics intended for the treatment, prevention, or diagnosis of a rare disease or condition. Furthermore, products that are hastened by financial gain during the development of drugs by removing specific testing requirements before filing a new drug application for FDA approval. This method prevents more cost-efficient versions of the medicine to emerge in the market, ultimately raising the price drastically.

Gilead declared receiving the "orphan drug" status as the virus began to grow in America. More than 60,000 cases of the coronavirus exist in the U.S. However, there are a total of 441,187 cases across the globe. Various organizations expressed disapproval over Gilead’s hunt to over-throw the FDA’s "orphan drug" status. Consumers are mentioning price-gouging concerns. Gilead identified the urgent public health needs posed by COVID-19 and is working to advance the development of Remdesivir promptly.

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