Sending Office: Honorable Eliot L. Engel
Sent By:
S.Chaudhary@mail.house.gov

Endorsing Organizations: American Hospital Association, American Society of Health-System Pharmacists, American Society of Clinical Oncology and American Society of Anesthesiologists

25 Current Signers: Mike Doyle, Gus Bilirakis, John Katko, Brian Higgins, Bill Posey, Suzan DelBene, Elise Stefanik, Nydia Velazquez, Anthony Brindisi, Adriano Espaillat, Bobby Rush, Tom Suozzi, Raul Grijalva, Eleanor Holmes Norton, Donald
Payne, Jr., Sean Casten, Lisa Blunt Rochester, Sean Patrick Maloney, Terri Sewell, Tim Ryan, Kurt Schrader, Sheila Jackson Lee and Brian Fitzpatrick

Dear Colleague:

Please join a bipartisan letter to the Food and Drug Administration (FDA) about drug shortages, which can hinder the delivery of high-quality patient care.

A variety of factors ranging from environmental disasters to issues with manufacturing standards can disrupt the supply of medical drugs important to patient care. These shortages have real-life consequences, which can threaten the health and safety of patients,
including:

  • Substitution of recommended treatments with alternative therapies
  • Compromising or delaying critical medical procedures
  • Rationing drug doses

In one recent example, U.S. hospitals struggled to administer cancer drugs due to a nationwide shortage of saline solution.

The frequency of drug shortages has spiked in recent years. In 2018, there were 186 new drug shortages, a 27% increase from 2017 and the most in the last five-years. On June 12, 2018 the American Medical Association declared drug shortages a public health
crisis. The Food and Drug Administration (FDA), which manages these shortages, has also taken steps to mitigate their impact.

In July 2018, then-FDA Commissioner Scott Gottlieb established the Agency Drug Shortages Task Force to identify the root causes of drug shortages and advance potential long-term solutions in a report to Congress.

This multi-agency panel has met several times and convened a number of stakeholder listening sessions, including in September and October of 2018. In addition, the Agency Drug Shortages Task Force kept a docket open for public comment through January 2019.
Despite all this stakeholder engagement over the past year, the task force has not yet notified Congress of its plan to submit a report.

Given Dr. Gottlieb’s recent departure from the agency, this bipartisan letter to Acting FDA Commissioner Ned Sharpless intends to remind the agency that addressing drug shortages is a priority for Congress, and asks for the release date of the task force’s
report.

If you would like to add your boss to this letter, please contact Sahil Chaudhary (S.Chaudhary@mail.house.gov) with Congressman Engel or Sophie Trainor (Sophie.Trainor@mail.house.gov)
with Congressman Guthrie.

Sincerely,

 

Eliot L. Engel                                                                                                   Brett Guthrie

Member of Congress                                                                                      Member of Congress