ASHP staff met with Food and Drug Administration (FDA) officials to discuss the growing problem of drug shortages.
The initial launch of the online resource center only featured critical shortages.
Soon after the launch of the Drug Shortages Resource Center, ASHP entered a partnership with the University of Utah Drug Information Service (UUDIS). A later agreement with Novation opened the door to expanded development of shortage bulletins.
The ASHP Guideline on Managing Drug Product Shortages was first published in 2001 to help practitioners navigate the challenges posed by shortages.
ASHP and the American Medical Association held a stakeholders meeting to discuss the impact of drug shortages on patient care. Following the Summit, the co-conveners reached out to stakeholders, the media, and others to draw attention to the issue and share recommendations from the meeting.
ASHP staff meet with Dr. Eve Slater (Assistant Secretary of the Department of Health and Human Services) and Dr. Lester Crawford (Deputy Administrator, FDA) to seek greater government involvement in investigating and solving the problem of drug shortages.
ASHP partners with Johns Hopkins Hospital and University of Wisconsin on national survey of the impact of drug shortages in acute care hospitals.
ASHP participates in a Drug Shortages Task Force convened by the Healthcare Distribution Management Association (HDMA)
Guidelines on Managing Drug Product Shortages updated to include new strategies for managing drug shortages.
ASHP, American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), and Institute for Safe Medication Practices convene stakeholder summit; begin outreach to stakeholders, the media, and Senate legislative staff
ASHP and staff from FDA Office of Drug Shortages meet to discuss potential areas of collaboration.
Open Forum during ASHP Midyear Clinical Meeting to educate members on the Society’s efforts to address drug shortages.
ASHP is invited to meet with Senator Amy Klobuchar (D-MN) and her staff to discuss provisions that should be included in a draft of drug shortages legislation.
ASHP had a great deal of influence on the provisions included in the first drug shortages bill, “The Preserving Access to Life-Saving Medications Act” (S. 296). The bill was introduced by Sens. Klobuchar and Casey (D-PA).
Work groups formed as part of the 2010 Drug Shortages Summit begin work on recommendations for legislative and regulatory action.
ASHP also worked with Reps. Diana DeGette (D-Colo.) and Thomas Rooney (R-Fla.) on the provisions in H.R. 2245, “The Preserving Access to Life-Saving Medications Act.”
ASHP & the American Hospital Association (AHA) present key research findings on the impact of drug shortages on hospitals with Sen. Klobuchar and Reps. DeGette and Rooney.
An ASHP white paper examing causes and solutions for the drug shortages crisis is published in the Food and Drug Law Institute’s journal, Food and Drug Policy Forum.
ASHP participates in roundtable with Kathleen Sebelius, Secretary of the Department of Health and Human Services and FDA Commissioner Margaret Hamburg
ASHP members key participants during a FDA public workshop where stakeholders discussed the causes and impact of drug shortages as well as potential solutions for preventing or mitigating shortages.
ASHP Legislative Day participants visited the offices of their congressional representatives to talk about the impact of drug shortages on patient care and to push for support for S. 296 and H.R. 2245
ASHP members Kevin Colgan and Richard Paoletti testified before the Health subcommittee of House Energy and Commerce Committee
President Obama issued an Executive Order directing the FDA to broaden reporting of potential shortages, expedite regulatory reviews, and increase staffing resources for the FDA’s Drug Shortages Program.
While some causes of drug shortages are known, others are not quite as clear and should be the subject of additional study, Kasey Thompson, vice president of ASHP’s office of Policy, Planning and Communications, told legislators during a Capitol Hill hearing looking into the drug shortages crisis.
Drug shortages compromise patient safety, ASHP told membesr of the Senate Finance Committee. “Every minute spent dealing with a drug shortage is time taken away from patient care,” he said.
ASHP member William Greene described the challenges drug shortages cause for caregivers during a hearing held by the House Energy and Commerce Committee.
ASHP and 22 health care groups, including the Susan G. Komen for the Cure Advocacy Alliance, the Society of Critical Care Medicine, and several pharmacy organizations, sent a letter to Congress asking for improvements to draft drug shortages legislation.
Drug shortages bills (S. 296 and H.R. 2245) were incorporated into both the House and Senate versions of legislation to reauthorize the Prescription Drug User Fee Act (PDUFA).
ASHP, and its partners ISMP, AHA, and ASCO place a series of ads in Politico, a newspaper read by Congress, congressional staff, and other policy makers.
The Senate passed “The FDA Innovation and Safety Act "(S. 3187), which included strong drug shortages provisions by a nearly unanimous vote.
The House of Representatives passed the Food and Drug Administration Reform Act (H.R. 5651) 387-5.
The Senate unanimously passed the "Food and Drug Administration Safety and Innovation Act of 2012," legislation that included several ASHP-supported provisions. The House of Representatives passed the bill by a margin of 92-4 a week earlier.
President Obama signed the Food and Drug Administration Safety and Innovation Act of 2012 (Public Law112-144). Title X of of the new law covers drug shortages.
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