On October 31, President Barack Obama issued an executive order instructing the FDA to broaden reporting of potential drug shortages, expedite reviews of applications to begin or modify production of these drugs, and provide more information to the Justice Department about possible cases of collusion or price gouging. The President also announced his support for House and Senate legislation that would require drug companies to notify the FDA 6 months ahead of a potential shortage.
In a statement released by ASCO, also on October 31, ASCO President Michael Link, MD, commented on the White House Executive Order on Drug Shortages, saying:
The problem of cancer drug shortages continues to compromise the best possible patient care and is setting back the significant advancements being made in clinical cancer trials. ASCO has worked hard over the past year to raise awareness of these shortages and to find both immediate and permanent solutions. The White House executive order is a good first step to addressing the problem. ASCO stands ready to work with Congress and all oncology stakeholders on a comprehensive solution that puts patient health and research progress first.
To report information on how oncology drug shortages are affecting your practice, contact:
- ASCO at publicpolicy@asco.org or 571-483-1368
- FDA at drugshortages@fda.hhs.gov
- ASHP at http://www.ashp.org/DrugShortages/Report/ ■