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.
The fact is that there are quite a few rare diseases out there that have long lacked any sort of effective medicines to treat them. The FDA considers a disease to be “rare” or an orphan if there are less than 200,000 cases in the United States. For diseases such as those, it’s simply not profitable for the giant pharmaceutical companies to invest the tens of millions of dollars and years of laboratory development and testing required to get a new drug to market because they would never sell enough doses to make back the money.
This program allows the federal government to subsidize such development and offers the manufacturer a longer window as the exclusive provider of the medication. This has resulted in the development of new drugs for some very rare diseases that previously would have doomed the relatively small number of patients who contract the illness.
The problem here is that COVID-19 can hardly be considered a “rare” disease in any way shape or form. If it was, we wouldn’t be talking about a pandemic 24/7. They got their request in under the wire because we still haven’t’ officially registered that many cases in the United States. But that’s only because it’s taking so long to test everyone. Nearly every medical expert agrees that the total number of people who either have the coronavirus or previously had it and recovered is probably far higher than the cap under the orphan disease designation. And if it’s not, it will be very soon.
So does that mean the FDA shouldn’t have granted the request or should pull the designation once we reach 200,000? I suppose we could be concerned over whether or not Gilead will engage in any sort of price gouging once the drug goes to market. (Assuming it’s truly effective in saving COVID-19 patients.) But like so many other things going on during this period of emergency conditions, I won’t be surprised if the FDA – along with many of us – turn a blind eye to those concerns in the interest of getting an effective treatment out of trials and widely available as soon as possible. If we catch them price gouging later, after the worst of the epidemic is behind us, a social pressure campaign could be mounted to try to change that.
