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
Please contact ASH Government Relations Manager
Stephanie Kaplan (firstname.lastname@example.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.
Reason for Shortage
BiCNU (Carmustine) Injection,
(100 mg, NDC 00015-3012-60)
Manufacturing delays at contract
BMS working to have product
released as soon as possible - planned date of release will be posted once
Cytarabine injection (powder for
Bedford Customer Service
Raw material issues
Bedford has all cytarabine
presentations on back order. The 1 gram vials have an estimated release date
of early-February, 2011.
APP has cytarabine 2 gram vials on backorder and the company estimates a
release date of late-March, 2011.
Hospira plans on releases of the 20mg/ml 5 ml and 100mg/ml 20ml and 20mg/ml
50 ml vials in February and ongoing releases of all strengths.
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