2011-02-10

In response to the record-breaking shortage of generic drugs for cancer and other serious ailments, Senators Amy Klobuchar (D-MN) and Bob Casey (D-PA) introduced legislation that would provide the Food and Drug Administration (FDA) with tools to help address and prevent future medication shortages. The Preserving Access to Life-Saving Medications Act (S 296) will require prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug shortage.

The Food and Drug Administration (FDA) reported 178 drug shortages in 2010, up from 157 in 2009 and 55 five years ago. According to some industry analysts, generic-drug manufacturers have consolidated in recent years, limiting production of many drugs to only one or two companies and tightening supplies. At the same time, some brand-name drugs' patents have expired and are no longer being made, and federal regulators have ramped up enforcement of quality standards, which restrict rapid, mass production.

Oncology and anesthesiology have been among the hardest hit by drug shortages, USA Today reports. In the past year, ASH has heard from an increasing number of members who have experienced a shortage of hematologic drugs for patients with a variety of conditions. The Society has most recently received feedback regarding the supply of BiCNU (Carmustine) and Cytarabine (ARA-C). Additional information about these drugs is included below.

The new legislation would give the FDA the ability to require early notification from pharmaceutical companies when a factor arises that may result in a shortage. These factors may include changes made to raw material supplies, adjustments to manufacturer production capabilities and certain business decisions such as mergers, withdrawals or changes in output. The bill would also direct the FDA to provide up-to-date public notification of any shortage situation and the actions the agency would take to address them.

ASH is working with Senators Klobuchar and Casey to ensure that the legislation addresses issues relevant to the supply and distribution of hematology drugs and is as strong as possible. Key issues include: improving communication among stakeholders in the pharmaceutical supply chain and hematologists; removing barriers faced by hematology drug manufacturers and the FDA to minimize the impact of drug shortages; and clarifying the definition of "medically necessary," which prompts certain notifications to the FDA related to drug shortages.

Please contact ASH Government Relations Manager Stephanie Kaplan (skaplan@hematology.org or 202-776-0544) if you are encountering any type of access and/or supply issues. As ASH continues to work with the Senate on this issue, it will be helpful to relay specific examples of problems experienced by members.

For more information on the following drug shortages and other hematology drug shortages, visit the FDA drug shortage webpage.

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