There’s more potentially good news coming out this week about some help in the battle against the global pandemic. Pharmaceutical giant Gilead Science has developed a new drug to treat people with COVID-19 called remdesivir. It’s still going through clinical trials, but the early results are described as being very promising. But this story has a slight hitch to it. Gilead applied for a special designation for their drug under what’s known as the “orphan drug” program and the FDA has approved the request. This could mean a lot more money heading into the company’s coffers for a longer period of time and, at least potentially, higher prices for the desperately needed medicine at the pharmacy counter. (Associated Press)
The pharmaceutical giant that makes a promising coronavirus drug has registered it as a rare disease treatment with U.S. regulators, a status that can potentially be worth millions in tax breaks and competition-free sales.
What that specialty status will actually mean for the marketing or profitability of the Gilead Science’s experimental drug remdesivir isn’t clear. The drugmaker did not immediately respond Tuesday to requests for comment.
Experts who have studied the so-called “orphan drug” program say the company’s request — and the Food and Drug Administration’s decision to grant it — seem inappropriate given the rapidly expanding threat of the viral outbreak.
The orphan drug designation is part of a program administered by the FDA Office of Orphan Products Development (OOPD). I’ve written about this particular program in the past and I’ve never really had a problem with it. Yes, it represents yet another case of the federal government tinkering with the free market, but it’s rarely used and the benefits to the public do, in my view, outweigh those concerns.