WASHINGTON (AP) — Facing public wrath, the maker of an experimental coronavirus drug said Wednesday it will waive a special regulatory designation that could allow it to block competition and boost its profits.
Gilead Sciences said it will ask federal regulators to revoke the orphan drug status it received for its experimental drug remdesivir. The status would have entitled the company to financial incentives and exclusive marketing for rare disease treatments.
The Food and Drug Administration granted the company’s request for the designation on Monday, noting that Covid-19 qualified as a rare disease under federal rules, since fewer than 200,000 Americans are infected.
But experts and public advocates blasted Gilead for seeking the status.
“Covid-19 is anything but a rare disease,” stated a letter sent to the company Wednesday by more than 50 consumer and patient advocacy groups. The groups said that millions of Americans are expected to be infected with the virus. As of Wednesday, more than 1,000 people in the United States have died, and reported cases topped 61,000.
Gilead said Wednesday afternoon that it asked the FDA to rescind the orphan drug designation and that it “recognizes the urgent public health needs posed by the Covid-19 pandemic.”
There are no FDA-approved drugs, vaccines or specific treatments for the coronavirus yet. A few experimental drugs are being studied, and vaccines are being developed.
Remdesivir, developed for Ebola, is being tested in at least five experiments. The drug interferes with viral reproduction and has shown some promise in lab and animal studies against other coronaviruses that cause similar diseases, MERS and SARS.
The drug has been given to hundreds of Covid-19 patients, but rigorous studies are needed to determine if it works before it is approved.
Congress created the orphan drug program more than 35 years ago to encourage companies to develop drugs for niche diseases and conditions, because if a drug company cannot profit from a cure, it has no economic incentive to work on it. Since then, filing for the program has become a standard industry tactic.
Under FDA rules, manufacturers of orphan drugs receive seven years of exclusive U.S. marketing rights and tax credits on their costs of research and development.