The Food and Drug Administration announced on Feb. 21 that the preservative-free methotrexate shortage would be adverted “Through the collaborative work of FDA, industry, and other stakeholders,” according to FDA Commissioner Margaret A. Hamburg, M.D. in a press release. The FDA has been working with U.S. pharmaceutical companies to find a remedy to the dire situation, and two U.S. pharmaceutical companies stepped up to the plate to work with the FDA, ensuring that families of pediatric cancer patients will have access to methotrexate.
On Feb. 17 the FDA expedited APP Pharmaceutical’s drug application to start manufacturing methotrexate. APP has been trying to get approval to produce the preservative-free drug since 2010. APP is based out of Illinois.
The other company, Hospira, also from Illinois, increased production in late 2011 and has been working to find a solution to the methotrexate shortage, according to a press release from Hospira issued on Feb. 14. According to another press release on Feb. 21, Hospira reported that an increased supply has already been shipped to hospitals throughout the U.S. Hospira also hopes that hospitals will be able to have extra stock on hand by mid-March.
The methotrexate shortage created a public outcry when articles by ABC News and the New York Times were published on Feb. 10, with many more news sources joining quickly after. Since then, families and charities dealing with childhood cancer have been calling for the public to contact congressmen and certain drug companies, the ones who can manufacture this specific drug, to encourage action for increased production. Methotrexate has been used since the 1960s to increase the survival rate of ALL to around 90 percent. Before that, a diagnosis of ALL was considered a death sentence. No one was sure what would happen to the pediatric cancer patients if they couldn’t get the appropriate amounts of methotrexate for their protocol, but they all agreed the result would not be good.
Around 3,000 kids each year in the US are diagnosed with ALL, and it is the most common form of childhood cancer. With the methotrexate shortage coming to an end, parents of ALL patients can focus on comforting their child through treatment instead of worrying whether or not the drug would be available to them.