FDA Grants Experimental Medicine Called Remdesivir To Treat COVID-19

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The Food and Drug Administration gave an experimental medicine called remdesivir to treat COVID-19 what’s called orphan drug status on Monday.

To qualify for an orphan designation, drug companies must show that their product will treat a population of fewer than 200,000 patients or that it would be unprofitable.

The agency’s decision would provide lucrative incentives to the drug’s maker, Gilead Sciences, and could keep lower-priced generic versions of the medicine off the market for several years if remdesivir is approved for use, public health advocates say.

The designation allows the pharmaceutical company to profit exclusively for seven years from the product, which is one of dozens being tested as a possible treatment for Covid-19, the disease caused by the new coronavirus.

Experts warn that the designation, reserved for treating “rare diseases,” could block supplies of the antiviral medication from generic drug manufacturers and provide a lucrative windfall for Gilead Sciences, which maintains close ties with President Donald Trump’s task force for controlling the coronavirus crisis. Joe Grogan, who serves on the White House coronavirus task force, lobbied for Gilead from 2011 to 2017 on issues including the pricing of pharmaceuticals.

Remdesivir is an intravenous, antiviral medicine that is being studied in clinical trials around the world as a possible treatment for COVID-19.

Clinical trials for remdesivir as a COVID-19 treatment got started in China in early February. Tests of the drug are now enrolling patients elsewhere, including the United States.

The FDA’s granting of orphan status for remdesivir as a treatment for COVID-19 came with financial incentives for Gilead that include tax breaks, waiver of FDA fees and market exclusivity for seven years if the drug is approved. New drug molecules typically only get five years of this exclusivity.

The agency decision drew criticism from consumer advocates.

“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,” said James Love, director of Knowledge Ecology International, a watchdog on pharmaceutical patent abuse.

The 1983 Orphan Drug Act gives special inducements to pharmaceutical companies to make products that treat rare diseases. In addition to the seven-year period of market exclusivity, “orphan” status can give companies grants and tax credits of 25 percent of the clinical drug testing cost. The law is reserved for drugs that treat illnesses that affect fewer than 200,000 people in the U.S. But a loophole allows drugs that treat more common illnesses to be classified as orphans if the designation is given before the disease reaches that threshold. As of press time, there were more than 40,000 confirmed cases of Covid-19 in the U.S, and some 366,000 worldwide.

The distinction could severely limit supply of remdesivir by granting Gilead Sciences exclusive protection over the drug and complete control of its price. Other pharmaceutical firms, including India-based pharmaceutical firm Cipla, are reportedly working toward a generic form of remdesivir, but patients in the U.S. could be prevented from buying generics with lower prices now that Gilead Sciences’s drug has been designated an orphan.

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