WASHINGTON, D.C. – Following a call from U.S. Sen. Sherrod Brown (D-OH) to address drug shortages, the Food and Drug Administration (FDA) announced that it has prevented 114 shortages since the implementation of an Oct. 31 Executive Order. The FDA also announced today that it has approved production of a new drug to fight childhood leukemia. Earlier this month, Brown wrote to FDA Commissioner Dr. Margaret Hamburg calling on her to work with drug manufacturers to ramp up production of Methotrexate, a drug used to fight acute lymphoblastic leukemia (A.L.L.), childhood leukemia.

“This is great news for the parents and patients who should be focused on fighting cancer and not worried about drug shortages,” Brown said. “While we’re working to address supply chain and manufacturing issues that cause these shortages, more needs to be done. That’s why I’m calling on my colleagues to pass the Preserving Access to Life-Saving Medications Act to trigger an alert to the FDA before a possible drug shortage.”

After receiving a number of letters from Ohio constituents over shortages of a drug known as methotrexate, Brown wrote to the FDA urging it to work with the drug’s manufacturers—including Ben Venue, Hospira, Inc. Sandoz US Inc., Mylan, and APP Pharmaceuticals—to address the supply chain and manufacturing issues behind the drug’s shortages. Methotrexate is used to treat acute lymphoblastic leukemia (ALL), an aggressive form of childhood cancer. Ben Venue Laboratories, Inc., one of the country’s largest suppliers of methotrexate, voluntarily suspended production at its Bedford, Ohio facility in November 2011. Since then, the supply of methotrexate has shrunk significantly, with many oncologists believing that only a two week supply remains. Brown also wrote to the four other domestic manufacturers of methotrexate requesting that they do whatever possible to increase the supply of the critical life-saving drug to help stave off a potential shortage.

Earlier this month, Brown stood with cancer patients at the University of Toledo Medical Center to highlight this critical problem. According to the Associated Press, at least 15 deaths in the past 18 months can be blamed on drug shortages. These deaths were caused either due to the preferred drug being unavailable, problems with the preparation or administration of the alternative medication, or because of dosing errors with the alternative medication. In 2009, 166 drug shortages were reported to the University of Utah’s Drug Information Service—the clearing house for drug shortage reports.  In 2010, a record 211 shortages were reported, and that record was broken again in 2011 with 267 reported shortages.

Last month, Brown convened a roundtable discussion in Columbus with hospital CEOs, Directors of Pharmacy, and other hospital staffers who confront this problem from around Ohio to discuss possible solutions to improve patient outcomes. There are a variety of reasons for drug shortages, including:

  • The manufacturer experiences quality control issues or production problems
  • Issues in the supply chain for raw materials
  • Delays in manufacturing or shipping
  • Mergers in the pharmaceutical industry – both branded and generic companies
  • The pharmaceutical company decides to stop producing the drug (often due to low profit margins)

In 2009, Brown joined cancer survivors, experts, businesses, and insurance companies at a forum on expanding access to cancer clinical trials at the Ohio State University Comprehensive Cancer Center. Following the forum, Brown introduced the Access to Cancer Clinical Trials Act¬, which was included in the health reform law signed in March 2010.