As healthcare providers across the U.S. desperately attempt to treat a rapidly growing number of patients with the coronavirus, a pharmaceutical company with ties to the Trump administration has been granted exclusive status for a drug it is developing to treat the illness—a potential windfall for the company that could put the medication out of reach for many Americans.
As The Intercept reported Monday, the Food and Drug Administration granted Gilead Sciences “orphan” drug status for remdesivir, one of several drugs being tested as potential treatments for the coronavirus, officially known as COVID-19. The designation is generally reserved for drugs that treat rare illnesses affecting fewer than 200,000 Americans—but companies can be eligible if the designation, as in this case of a rapidly spreading virus, is made before a disease spreads beyond that limit.
“It is insane and unacceptable that the Trump administration has given the Gilead pharmaceutical corporation a seven-year monopoly on a potential coronavirus treatment. We will not tolerate profiteering. Any treatment or vaccine must be made free for all.”
—Sen. Bernie Sanders (I-Vt.)
About 40,000 Americans had contracted COVID-19 when the orphan status was granted to remdesivir Monday, and the disease is spreading faster in the U.S. than in other countries. By Tuesday afternoon, more than 51,000 Americans had confirmed cases.
Having secured orphan drug status, Gilead Sciences can now profit exclusively off the drug for seven years and could block manufacturers from developing generic versions of the drug which might be more accessible to many patients. The company can set price controls on the drug as well as benefiting from grants and tax credits.
As The Intercept reported, the designation was given to a company where Joe Grogan, a member of President Donald Trump’s “coronavirus task force,” worked as a lobbyist from 2011 to 2017, often working on issues regarding drug pricing.
“This is a massive scandal,” tweeted Ryan Grim, Washington, D.C. bureau chief for The Intercept.
This is a massive scandal— Ryan Grim (@ryangrim) March 24, 2020
Trump's FDA just granted a drug that is being used to treat coronavirus patients, developed previously by Gilead Sciences, "orphan" status, giving the company seven years of exclusivity. https://t.co/mFaXfMWzCx by @fastlerner, @lhfang
Sen. Bernie Sanders (I-Vt.) called the reports of profiteering by Gilead Sciences, with the support of the Trump administration, “insane and unacceptable” and demanded that treatment for the coronavirus be made free for all Americans.
It is insane and unacceptable that the Trump Administration has given the Gilead pharmaceutical corporation a seven-year monopoly on a potential coronavirus treatment.— Bernie Sanders (@SenSanders) March 24, 2020
We will not tolerate profiteering. Any treatment or vaccine must be made free for all. https://t.co/VCdgBSZJw6
The Orphan Drug Act of 1983 was passed to ensure medications for rare diseases can be developed, and was meant to benefit companies which may not recoup their research costs after their drugs are put on the market.
But as Sharon Lerner and Lee Fang reported at The Intercept, the “orphan” status is expected to create a massive windfall for Gilead.
“The special orphan designation,” they wrote, “was given to remdesivir despite hefty support by the government for the development of the drug. Gilead Sciences’ remdesivir was developed with at least $79 million in U.S. government funding.”
“The Trump Administration just gave the Gilead pharma corporation a seven-year monopoly, so they can charge patients outrageous prices for the medication we’ve already paid for,” Social Security Works tweeted.
Our taxpayer dollars paid to develop remdesivir, a potential #Covid19 treatment.— SocialSecurityWorks (@SSWorks) March 24, 2020
But the Trump Adminin just gave the Gilead pharma corporation a 7 year monopoly, so they can charge patients outrageous prices for the medication we've already paid for: https://t.co/AQpTWmajmE
Gilead’s rush to profit off a potentially life-saving drug in the midst of a public health and economic crisis could prove “deeply harmful” to the American people, many more of whom are expected to contract the coronavirus, said government watchdog Public Citizen.
“Remdesivir is one of relatively few medicines that may prove effective in treating COVID-19 this year,” said Peter Maybarduk, director of the group’s Access to Medicines program. “The government should be urgently concerned with its affordability for citizens. Instead, the FDA has handed Gilead, one of the most profitable pharmaceutical corporations on earth, a long and entirely undeserved seven-year monopoly and, with it, the ability to charge outrageous prices to consumers.”
“Gilead has gamed the system by rushing through its ‘rare disease’ orphan drug application,” Maybarduk added. “Its action is disingenuous and outrageous.”
The grassroots group ACT UP, which has fought for decades for equitable access to HIV-AIDS drugs and to healthcare, also expressed outrage on social media.
Trump’s FDA just handed over a 7-year monopoly for Gilead Sciences drug, remdesivir—a promising treatment for #COVID19 while $79 million of the funding came from U.S. taxpayer dollars. This is how pharma greed kills. https://t.co/VSGzdlW0sj— ACT UP NY (@actupny) March 24, 2020
“This is how pharma greed kills,” the group said.
This article was written by Julia Conley and republished here with permission.
It is obvious you are pro socialism. The medical community has looked into trying hydroxychloroquine with azithromycin. Yes, there is a rush on it, although it may be far less expensive than remdesivir.
Dont listen to Sanders—do you want to live under socialism, just like Sanders is promoting? btw, that wont happen in the US!
Kristen Michaelis CNC says
I don’t know what gave you that idea. I have posts written on my site from Joel Salatin, advocating his Libertarian leanings as well as posts asking readers to contact their congressmen to protest Democrat and/or Republican written legislation that would hurt small family farms.
When I talk about politics, I mostly write about the intersection of food, public health, and unfair legislation or enforcement (without advocating for any particular political party).
You can check my “Food, Politics and Philosophy” posts out here:
Also, for future reference, I am neither pro-unfettered capitalism or pro-socialism. The economic system I advocate for is Distributism. Pretty sure I’ve mentioned it before over the years, but if it’s new to you, read this:
Rachel Ramey says
There’s a clear political bias from the author here, sure, but that doesn’t change the actual FACTS of the article. Whether a Republican or a Democratic administration is doing it, this kind of conflict of interest and abuse of power is not good.
And this is a surprise!!??!!! Dang!!! I would have been more surprised if they hadn’t!!!! As a mom of autistic children….nuttin they do surmises me….if they act logically or humanely….then color me SOOOOO surprised!!!!!!!
Kristen, this is an FDA Issue, and everyone knows they are bought and paid for and have been around long before President Trump or his “Administration” has been making any decisions. Maybe Pres. Trump has not fully handled the FDA’s corruption, but to keep “blaming” him and his administration for the way the Big Pharma has been getting away with corruption forever with the FDA’s approval is not targeting the correct culprit. If is pretty apparent by your article that you are not a good journalist or you would have done your proper research and investigation before forwarding this “information”. The fact that Pres. Trump encouraged citizens to NOT run into get “tested” for the COVID 19 tells me that he is NOT wanting more citizens to be vaccinated or drugged by the medical industry. Play fair or go home. Don’t spread the MSM propaganda … we have enough of that already.
Kristen Michaelis CNC says
I wrote plenty of articles critical of the Obama administration too. My only concern is in advocating for a just local food system, empowering individuals to take ownership of their own health and wellness, and improving the systems of public health so that mismanagement and poor decision making by our leaders can be highlighted (and hopefully corrected!)
Which is precisely what happened in this case. Public outcry against Gilead Pharmaceutical caused them to withdraw their request for orphan drug status by the FDA! People like us getting this story in front of the public made positive change happen.
EXCELLENT Comment – Well thought out and not political. It’s time to stop blaming Presidents for every ill in this Country. Finally, I agree this post by the Author seemed completely biased.
As a Christian, you too, know that Satan[that rat] is the current ruler of the medical, political, and commercial world. Since he has a short period of time left his determination to destroy God’s creation is unrelenting and getting worse. [Revelation Chapter 12] But that’s not to say it isn’t painful to watch. Fortunately we know God will intervene or the Bible says “No flesh will be saved…” God’s Kingdom will be such a relief that our happiness will be immeasurable. ☺ Daniel 2:44
Richard VanDyke says
Well now, you would have us believe that as taxpayers who have already financed this endeavor that we should also pay to make the vaccine free to all? Got news for you- we’re going to foot the bill 100% if Goverment is involved. It’s our money people. So Bernie, nice try at socialism yet again.
Big pharma has been in place long before Trump. Additionally, The Drug Price Competition and Patent Term Restoration Act passed in 1984 was originally put in place to give drug companies exclusivity in return for shouldering the risk and expense of developing a drug. While it’s true that the pharmaceutical companies and the FDA are finding ways around the 1984 act in order to gouge consumers, your connection to Trump was unfair, biased, inaccurate and inappropriate. It is for this reason I unsubscribed from your newsletter.
I’d like to point out that Trump pushed for the use and approval of this drug, putting pressure where necessary, when FDA approval can usually take years. Before you malign Trump from an uneducated standpoint, do some research and don’t just wallow into that “It’s Trump’s fault for EVERYTHING” mindset so many liberals tend to espouse, frequently past all point of logic and common sense. Like Sayer Ji, I wish you’d report on health and food and the body and leave the politics out of it.
It would be impressive if you at least modified your article, if not removed it fully, rather than posting defensive replies.
Actually Sayer Ji does get pretty political a way – but he is much more adept at keeping it objective and from an informed or experiential and knowledgeable basis.
AGREED – Please report and bring us the great stories without the politics. Honestly, as soon as I see a political bent to anything these days….I stop reading. Too much spin, to many agendas and not enough truth and common sense in the political world.
“TRUMP’S FDA”, you had to put your political 2cents in… You obviously think your smarter then the rest of us.
Nicholas Jordan says
I have great depth of studies on this ~ originally bio-warfare developed even if not intended to eradicate every one simple OTC Retail approaches are effective;
There is no need to advance exotic fixes if it had not occured;
Did not study Gilead as any field has a top 100 with many of them doing work that humans would suffer without so balance has to be taken
Tocopherol for example A statistical error in the estimation of the recommended dietary allowance (RDA) for vitamin D was recently discovered; in a correct analysis of the data used by the Institute of Medicine, it was found that 8895 IU/d was needed for 97.5% of individuals to achieve values ≥50 nmol/L.
See especially Thailand Medical News
For a blog mostly about healthy living I’m surprised you even buy into the hysteria and that this exists…
Profiteering from vaccines is the least of your worries when you look at how many people have died taking it, and have procured neurological or otherwise unrelated illnesses afterwards. The very fact that they are already drawing up unique rights for people who are willing to vaccinate themselves as many times as the government wants them to, vs the people who don’t want to vaccinate because of how experimental and dangerous it is is shocking to say the least.
They’re starting to camp outside grocery stores with their stupid vaccine tents, creepily clamering for pregnant women to do this, and allowing schools to jab children with this without anyones consent, it’s madness. All because people eat up the narrative of playing the hero.
What people will throw away for their own ego just astounds me