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Federal Officials Press FDA to Address Drug Shortages

June 22, 2018

Members in both the U.S. House and U.S. Senate continue to express concern about the intensity of current drug shortages and the impact on the ability of health care providers to deliver high quality care. They are urging the U.S. Food and Drug Administration (FDA) to exercise its authority to the fullest extent possible to address the shortages.

Last week, a bipartisan group of 31 Senators—including Pennsylvania Senator Bob Casey (D-PA)—cosigned a letter urging FDA Commissioner Scott Gottlieb, M.D. to convene the Drug Shortage Task Force. The lawmakers want the task force to work with stakeholders and federal agencies to:

  • Determine the root causes of drug shortages
  • Develop recommendations to ensure appropriate supplies of essential medications are always available

The Senate letter expressed appreciation for work that has been done to mitigate the impact of ongoing drug shortages that were significantly exacerbated by damage to drug manufacturing facilities resulting from Hurricane Maria. However, Senators cautioned that “drug shortages continue to present consistent, frequent and significant risks for patients and threaten the stability of our health care system.” The letter called for exploration of the causes of drug shortages and cited that work is needed to improve redundancy and preparedness in the supply chain.

Similarly, a letter spearheaded by Congressman Mike Doyle (D, PA-14) and Brett Guthrie (R, KY-02) called for the FDA and other relevant federal agencies to take appropriate action to ensure essential medications are always available. They cited concern that persistent shortages can last for months or longer, and affect all classes of medications.

The House letter was co-signed by Pennsylvania representatives Matt Cartwright (D, PA-17), Brian Fitzpatrick (R, PA-08), Mike Kelly (R, PA-03), and Lloyd Smucker (R, PA-16).

In an announcement this week, and detailed in the FDA’s 2017 annual report to Congress on drug shortages, the FDA outlined its efforts to help prevent and mitigate drug shortages of medically necessary products. The agency pointed to improvements in the production of critically needed intravenous saline and other fluids. The FDA indicated it has used expedited reviews and supplements to add capacity and additional supply, and temporarily allowed for the importation of saline.

The FDA also highlighted efforts to work with companies to increase the supply of injectable opioid analgesics (pain medications), including hydromorphone, morphine, and fentanyl, in order to address shortfalls in the market.

The FDA continues to post information about drug shortages on their drug shortages website. Shortage notifications and updates may be reported to FDA at the drug shortage website or via its collaborative portal.  

HAP’s emergency preparedness team has been working with member organizations and the Pennsylvania Department of Health to assess regional shortages, and will continue to do so. Hospitals are closely monitoring the shortage and implementing appropriate protocols and practices.

For more information contact Mark Ross, HAP’s vice president, emergency preparedness. For questions about federal efforts to address drug shortages, contact Laura Stevens Kent, HAP’s vice president, federal advocacy.

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