According to a story from The Intercept, Gilead Sciences’ antiviral drug remdesivir, which is being tested as a treatment for coronavirus/COVID-19, was just given Orphan Drug designation by the US Food and Drug Administration (FDA). While normally this designation is a sign of progress for the development of a treatment on our site, in this instance, the use of the designation for this drug feels somewhat questionable.
About Orphan Drug Designation
Orphan Drug designation is typically reserved for drugs that are considered rare, which is defined as any illness that affects less than 200,000 people in the US. To qualify for this status, the drug must either fulfill a currently unmet medical need or display potential safety and efficacy advantages over currently available treatments. This designation confers significant benefits to the recipient company, such as the waiving of certain fees, tax breaks, and a seven year period of market exclusivity if the drug is approved.
Remdesivir, COVID-19, and Gilead Sciences
Remdesivir began clinical testing in February in China and was provisionally approved as a treatment for serious cases of COVID-19 in the Czech Republic. on March 20th, President Trump announced that the drug would be available from Gilead under compassionate use for COVID-19 patients, but this status was promptly revoked on the 23rd when the company announced that the demand for the drug was overwhelming their ability to produce it.
As of the time of writing (March 24th), there are currently 46,455 cases of COVID-19 in the US. By that number, it still falls under the qualifications for a “rare” disease. However, the total lack of sufficient testing means that the number of cases in reality may have in fact exceeded the 200,000 patient benchmark for the designation. Regardless, it is highly likely that the number of cases in the US could rise to a far greater number in the near future.
Gilead maintains close ties to the current administration’s coronavirus task force, particularly through Joe Grogan, a member of the task force that served as a lobbyist for the company from 2011 to 2017.
Profiting From Disaster?
There is much concern that granting the designation could limit patient access to the drug if it is approved; demand for it could be far higher than it is now and the company is already claiming it’s overwhelmed. The policy of market exclusivity could prevent much needed generics from being imported into the country to meet the need for victims of the pandemic. Gilead would therefore have total control over pricing and production in the US. Such a situation seems like a recipe for disaster, opening up the possibility for insufficient supply and delays in treatment that could easily cost thousands of people their lives. The company claims to be making efforts to ramp up its production capacity, but it’s unclear how long such changes will take.
Some infectious disease experts project that as much as half of the US population or more could be infected by coronavirus/COVID-19 before this is all said and done. Unfortunately, this isn’t the first time that a drug company has taken advantage of Orphan Drug Act loopholes with the goal of making a quick buck. Clearly, Gilead is trying to be the first company with a treatment on the market before a vaccine or better treatment comes into play.