Gilead Rescinds Orphan Drug Status Request For Potential Coronavirus Treatment Amid Exploitation Outcry
The drugmaker had applied for the status for its experimental drug remdesivir--and was it granted by the FDA--because the number of COVID-19 cases in the U.S. is still under 200,000. The designation would have granted Gilead lucrative perks, including the ability to keep cheaper versions off the market for years. "Gilead must have been feeling the heat,"James Love, director of Knowledge Ecology International told NPR. "I think it's embarrassing to take something that's potentially the most widespread disease in the history of the pharmaceutical industry and claim it's a rare disease."
The New York Times:
Gilead Withdraws Request For Special Orphan Status On Experimental Coronavirus Treatment
Bowing to criticism that it was exploiting the coronavirus pandemic, the drugmaker Gilead said on Wednesday that it would no longer seek orphan-drug status for remdesivir, an experimental drug that is being tested as a possible treatment. The Food and Drug Administration had only granted the special designation on Monday — which gives drug companies a seven-year monopoly on sales, tax credits and expedited approval. Gilead said it asked the agency to rescind the status. (Thomas, 3/25)
NPR:
Gilead Asks FDA To Rescind 'Rare Disease' Status For Coronavirus Drug Remdesivir
For its part, Gilead said it could proceed to develop the drug quickly without the special regulatory status. "Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation," the company wrote in a statement. "Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited." To get orphan status, a drug company must show its drug serves a population of fewer than 200,000 people in the United States, "at the time of the submission of the request for orphan-drug designation." Gilead's latest statement indicates that this was early March. (Lupkin, 3/25)
In other news —
ABC News:
Minnesota Doctor Engaged In FDA-Approved Hydroxychloroquine Trials Lacks Volunteers
A Minnesota doctor is calling on healthcare workers and people who have tested positive for COVID-19 and are showing early symptoms of infection to participate in two of the first trials of the malaria drug Hydroxychloroquine to treat coronavirus patients. Dr. David Boulware, an infectious disease specialist from the University of Minnesota, is one of the first doctors to receive approval from the Food & Drug Administration (FDA) to conduct a pair of clinical trials of the drug, which has been heavily promoted by President Trump as a potential antidote to the outbreak. (Rezvi, 3/25)
