The End of the Methotrexate Shortage, Thanks to Pfizer?
Pfizer addresses U.S. methotrexate shortage that hurts RA patients
Earlier this year the FDA approved an abbreviated new drug application, securing Pfizer’s right to sell injectable methotrexate in the U.S. Recently, Pfizer says they began shipping to customers. This move by Pfizer addresses an urgent shortage of methotrexate in the U.S. that has affected many Rheumatoid patients. The FDA had previously estimated that the shortage could last from 2010 through 2014.
The methotrexate Pfizer sells is manufactured in Bangalore, India at Strides Arcolab. According to Pfizer media representative Lauren Starr, “Pfizer Injectables manages commercial activities and distribution, but Strides manages the manufacturing process.”
According to the Pfizer’s recent methotrexate press release:
Pfizer Injectables, part of Pfizer Inc.’s (NYSE: PFE) Established Products Business Unit, announced today the addition of methotrexate injection, USP to Pfizer Injectables’ growing portfolio of generic oncology products. Methotrexate is indicated for certain types of neoplastic diseases, a severe recalcitrant disabling type of psoriasis that is not adequately responsive to other forms of therapy and certain types of active rheumatoid arthritis (RA) in adults and children.
“U.S. drug shortages remain an ongoing issue and serious threat to public health. We have been placing our priority on making available quality products from reliable supply sources, because every day counts for patients who are waiting,” said James Hageman, vice president of Pfizer Injectables. “With the introduction of methotrexate injection, USP, we are helping to address drug shortages for patients and their caregivers.”
Reason Pfizer decides to sell methotrexate now?
It’s a relief to see someone acknowledge that the methotrexate shortage is a serious public health issue. I asked Ms. Starr whether protecting the availability of this old generic drug might be considered an act of goodwill to U.S. patients, but she would not go that far. “Methotrexate is an important product in the generic injectables space and was launched as there is a market need and historical market shortage. Pfizer Injectables is committed to methotrexate as part of our growth initiatives to expand the breadth and depth of our portfolio,” she said. It appears that in this case, business expansion overlaps with the needs of rheumatology patients.
Pfizer declined to comment on whether the price of methotrexate might stabilize to pre-shortage levels.
Significant lessons from the methotrexate shortage
The current methotrexate crisis may be nearing its end, but the past year has crucial lessons for Rheumatoid patients, lessons I have heeded carefully, as President of the Rheumatoid Patient Foundation (RPF).
As more patients were unable to fill their prescriptions for injectable methotrexate, more oral (pill) prescriptions were filled. And, not surprisingly, some pharmacies experienced resulting shortages in pills as well. I read whatever I could dig up, and some things did not make sense.
- Congressional hearings took place. House Committee on Oversight and Government Reform Chairman Darrell Issa demanded answers from the FDA.
- Public broadcasting did specials on TV and radio about the horror of a shortage in the United States of a drug used for rare childhood leukemia (methotrexate).
- Reports and orders were issued and legislation was passed to help alleviate shortages and ensure that FDA is more aware of future possible drug shortages.
Yet, nowhere in any of that were the words “Rheumatoid Arthritis.”
The crisis that Rheumatoid patients were experiencing was not recognized because officials were unaware that an injectable oncology drug is even used by hundreds of thousands of people with Rheumatoid Disease. Last spring, I spoke with public relations representatives of the FDA who were unaware that the methotrexate shortage affected people with RA or what a crucial part of rheumatology care methotrexate often is. And congressional offices I met with last month were well aware of events surrounding the shortage, but stunned to learn people with Rheumatoid Disease use methotrexate.
This issue and others easily persuaded them of the need for continued interaction with the RPF as the representative of Rheumatoid Disease patients. And it has obviously convinced this patient that we cannot wait to become involved with government where the needs of patients are concerned. Please join the RPF today, and stay tuned for future opportunities to help the RPF improve the health of everyone with Rheumatoid Disease.
Related reading
- Confusion & Blame Surround Methotrexate Shortages & Recalls
- List of all RA Warrior articles on methotrexate
- RA News: Pfizer Pill Beats Methotrexate, Alcohol Reduces RA Risk, Periodontal Disease High
I so hope we see relief in this shortage soon. I recently had to go without my dosing for two weeks and noticed a huge increase in joint pain…I will find out soon, as it is almost time to refill. Kim
I take Methotrexate weekly, with Remicade infusion monthly. Currently, I am taking the pill form. I have been on my body max. tolerance for about a year. My Rheum. is at the end of choices/methods to deal with the side effects that impact my life. His suggestion is to go to the inject able, but I am afraid of getting switched then not being able to find it any where. So, currently, I am still dealing with the pill form. I am just coming off a very bad week with the Methotrexate side effects so I’m very torn.
I’m also wondering if this shortage was a means to open the door to a higher priced injectable generic drug by creating a higher demand?? (I don’t Know) It seem most all non generic specialty drugs that I need to combat my
RA have been a fight with the ins. co.s Sometimes experiencing lapses in my meds. in order to receive the meds.
Sorry for the frustration, it just seems like the hill that has to be climbed while patients with RA are fighting to get out of bed every morning and physically move their bodies every day, is such a sad challenge in a country where medical advances are said to be the best. I just don’t get it!
Since I tolerate the pills with only mild fatigue, I never paid attention to the injection form. I had to switch pharmacies to get my methotrexate because the supplier was not reliable and they had run out. It is affecting the pill form slowly but surely. What a mess! I’m glad I’m not a pharmacist! 🙂
The acr wrote a letter to the FDA….. I wonder why they didn’t read it and/or didn’t get the word out appropriately. We r a huge population of disabled folks!
I would think that the prescription load for this drug would tell the story. Surely there are many more RA and PSA patients using injectable MTX than onocolgy patients. I could be wrong. This is afterall a tried and true chemotherapy drug and may be used not just for childhood leukemia but as part of the mix of many chemo treatments. I guess I am stunned though that the FDA ignored it’s use by so many patients in an end-use situation since they actually would have approved this use. Many cancer patients would be unaware that this is what they are taking while RA patients are very well aware since they inject it themselves!
Yes, obviously someone somewhere at the FDA had to know – when it was approved for that use. I guess the size of agencies would be the explanation for not every person working for FDA necessarily knowing all the approved indications of each drug. The problem here was one of public relations – the PR people I talked to did not know. And whose job was it to get the message right in the media and to congress? I don’t know – maybe the same part of the agency.
Kelly, thanks so much for fighting the fight for all those RA and JRA patients in need! I, too, am confused as to whose duty/job/responsibility it is to inform the powers that be of the importance of methotrexate to patients other than oncology patients. The list of uses, side effects etc. is a mile long on the pill pkgs, and that info has to be gathered from some medical authorities. The uses for simple aspirin in a medical book is quite long, but medical people cannot gather an equal amount of info on something a bit stronger –like methotrexate– to estimate production needs for our population??? Grrrr………..Thanks, Kelly, for doing so many of these jobs that have been undone til you came along and put them on your strong (yes, strong!) shoulders!
i’m sad to say that these drugs open the door to more profit and all those needing this medication have been held hostage for a greater cause, money.
issa is a republican money machine and we should all be outraged!
was this a world wide shortage? i think not!
corporations buy votes and issa is a vote seller, he works like a mouse trap.
just look at his votes on women health issues?
really, pfiser, did a galant thing?
As you may recall from recent news, a lab in the US that packages steroid injection solutions distributed this Summer, large quantities of contaminated product to 23 states in the US, making sick over 123 patients, some 9 of whom have died to date. It turns out that the type of lab that packages these solutions has no oversight of product and none is currently required by any government agency or law in the US. I can not help but wonder as a rheumatoid patient that injects Methotrexate do we know who is overseeing this new packaging and production of Methotrexate in India?
I worked pediatric oncology in the 90’s for a short time. The oncology doses of methotrexate are much higher, that is the only reason the focus is with that particular use. I remember continuous infusions lasting three days of MTX for kids with leukemia, that would happen several times. I do not think that we are being ignored, I just think the oncology use is very high. Without the drug their LIVES are in danger. Once remission is made anything that compromises that, ie. lack of the MTX, makes treating a recurrence successfully more unlikely.
Good point, Kathi. I just found out today that the recall has been expanded to include all New England Compounding Company injectables as a precaution, and MTX is on the list. Please check your vials and call your doctor if yours was made by NECC. Hopefully no more people are affected by this. 🙁
Cindy raises concerns about the price of injectable MTX. The good news is, it’s cheap. I have a 10 ml bottle- larger than what was prescribed, larger than what my &%$#% insurance company would pay anything towards. It cost a little over $70. Although it seemed steep at the time, that was the beginning of June, I’m still using it, and there are still several doses left. If your point of reference is the price tag on a biologic, it’s not anywhere near that expensive.
True, 70$ is still cheaper than some other medicines, but a 10 ml bottle was 30$ just a short time ago. So I’m still hoping that it will come back down to where it always was after the shortage eases.
Pfizer spokeswoman said:
“Methotrexate is an important product in the generic injectables space and was launched as there is a market need and historical market shortage. Pfizer Injectables is committed to methotrexate as part of our growth initiatives to expand the breadth and depth of our portfolio…”
Patents have or soon will expire for several of Pfizer’s blockbuster money making drugs — Lipitor, Viagra, Protonix, Detrol — so it’s not an act of goodwill, but a business opportunity — to market a generic injectable drug for which there has been a continual shortage at a time when Pfizer is losing revenue from several brand name drugs going off patent and few blockbuster drugs in their pipeline to replace them.
http://www.nytimes.com/2012/10/18/business/drug-makers-stalled-in-a-cycle-of-quality-lapses-and-shortages.html?hpw&_r=0
The above article was in today’s New York Times. While the author doesn’t specifically mention methotrexate, the article does give an overview of some of the problems (including the infamous bucket of urine)in pharmaceutical manufacturing.
Thanks, Anne.
I read the NY Times article linked here yesterday – wow! Scary! We REALLY need to do something about the the quality and safety of our drug supplies! Is it the FDA that’s not doing it’s job or do they not have the funding to do it? But I think people need to be aware that this isn’t just a blip, it’s just the tip of an ice berg and we need to correct course but quick!
When you hear politicians yammering about “cutting runaway Washington spending” and “getting rid of job-killing regulations” the FDA is a prime example of what they are talking about. Personally, I think we should spend whatever it takes to get enough inspectors out there to eliminate ALL buckets of urine in pharmaceutical plants, just for starters. I don’t know how many more people have to die from contaminated food and drugs before we are willing to regulate and inspect the heck out of these industries to keep us all safe, and before we are willing to spend the necessary tax dollars to pay for the inspectors it takes.
This certainly does seem like a place where government oversight and regulation should be working for us and should be a good and wise use of our tax dollars. I do understand the recoil that exists against government regulation since it often seems to work against effincency and speed. In some cases, government regulation creates rules that work against our best interest – case in point, the rule that doesn’t allow medicare recepients to receive copay assistance for biologics. This, of course, is a result of a rule made by lawmakers who failed to understand the ultimate results of their rule.
But I think it’s clear that our pharmacy/drug maufacturing industry is in serious trouble and needs some serious work. Vulnerable patients are being put in danger as a result of this behavior. Action is desperatly needed.
Regarding Medicare beneficiaries ineligible for biologic drug companies’ financial assistance programs — this was most likely part of the Medicare Modernization Act of 2003 that created the Medicare drug benefit – a law that was written by pharmaceutical lobbyists. See CBS 60 Minutes “Under the Influence:”
http://www.cbsnews.com/8301-18560_162-2625305.html
Unlike Parts A and B, which are administered by Medicare, Part D, the drug benefit is “privatized.” Medicare contracts with private companies that are authorized to sell Part D insurance coverage.
http://www.medicareadvocacy.org/medicare-info/medicare-part-d/
In my opinion, making Medicare beneficiaries ineligible for copay assistance for biologics, allows drug companies and private insurance companies selling Medicare Part D to make more of a profit off expensive biologics.
What a shock to have my much needed 2.5 Methotrexate Tablets more than double in price. I feel it is yet another way the drug companies are looking to get more money by creating a shortage in supply. If there was another way I could find to stay walking and functional I would quit being held hostage and stop taking this drug. RA is definitely second to cancer according to the drug companies.
But realizing that once the price goes up, no matter the supply later, it will never come down. So again we are subject to greed.