American Society of Hematology

White House Issues Executive Order Directing the FDA to Reduce Drug Shortages; Supports Legislation to Require Drug Companies to Report Shortages

Published on: October 31, 2011

President Barack Obama has issued an Executive Order directing the Food and Drug Administration (FDA) to reduce drug shortages, an escalating problem that currently affects dozens of life-saving drugs, including ones used in hematology/oncology, anesthesiology, emergency medicine, and infectious disease.

The order, the first since 1985 by a president to influence the functions of the Food and Drug Administration, is part of a series of recent executive orders involving such disparate issues as mortgage relief and jobs for veterans intended to show that the president is not willing to wait for congressional action to address urgent problems.

ASH has been leading national advocacy efforts for the past year calling on both congress and the administration to prevent and mitigate drug shortages. The Society was the first organization to demand congressional hearings on the causes of the problem; endorsed legislation to increase FDA authority; served as an expert panelist at a September meeting of the FDA identifying potential solutions; and recently met with senior officials at the Department of Health and Human Services to urge immediate action to respond the drug shortage crisis.

The Society is pleased the administration has recognized drug shortages are a critical problem and that it needs to do more to help solve it. The president's order, however, is only a first step that, while helpful, will not be able to resolve the problem completely or soon. ASH will continue to urge for legislation granting the FDA more authority and resources to adjust the nation's drug market and additional strategies to prevent disruptions to patient care. This includes: increasing FDA authority under The Preserving Access to Life-Saving Medications Act (S. 296/H.R. 2245); improving FDA communication with stakeholders; examining the impact of current FDA requirements on shortages; developing a national drug registry; and expanding "orphan drug" status to incentivize continuous production of generics.

The president's order instructs the FDA to do three things: broaden reporting of potential shortages of certain prescription drugs; speed reviews of applications to begin or alter production of these drugs; and provide more information to the Justice Department about possible instances of collusion or price gouging – a response to the emerging "grey market" ASH reported concerning ARA-C in which some wholesalers sold the drug at huge mark-ups.

In addition, President Obama promised to strengthen the staff of the FDA Office of Drug Shortages (something ASH specifically called for) and announced his support for the pending legislation that would require drug manufacturers to notify the FDA six months ahead of a potential shortage. Currently, drug makers are only required to notify the FDA if medically necessary drugs are being discontinued. The FDA does not have authority to force drug manufacturers to keep producing drugs, and notification of shortages is voluntary.

ASH will continue to work with the administration and congress to identify potential solutions to this critical issue and provide information and updates online about hematology drug shortages.

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