Monday, November 4, 2013
ASH Applauds FDA’s Role in Preventing Drug Shortages, but Will Continue Monitoring the Situation
For two years the American Society of Hematology has been outspoken about the issue of drug shortages, especially when certain medically important biologics had been excluded from the list of lifesaving drugs.
Last year Armand Keating, MD, who was ASH President at the time, said that the bipartisan legislative effort to help mitigate the drug shortage was a great start but didn’t go far enough because of the exemption of biologics and plasma product drugs.
But that omission seems to have been addressed by the Food and Drug Administration, which last week announced two critical steps toward preventing and resolving the drug shortage -- a strategic plan and proposed rule requiring manufacturers to notify the agency about possible drug shortages six months in advance.
I spoke with current ASH President Janis L. Abkowitz, MD, today about the announcement and she said that ASH applauds FDA for its actions, but that the society will continue to monitor the drug shortage situation through its membership.
“We think that broadly defined, the drugs included by FDA are perfect in scope,” she said, noting that she has not yet seen an actual inclusion list.
“ASH will continue to monitor all hematological drug shortages and continue to work with the FDA, other appropriate federal agencies, and relevant policymakers to protect Americans’ access to lifesaving drugs,” she said, adding that many aspects of the drug shortage are beyond the purview of the FDA, and that there is no single solution to the complex factors leading to drug shortages.