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
Click here to read the comments or make a comment on this post.
Tweet it!