ASHP's Drug Shortages Advocacy
The American Society of Health-System Pharmacists' (ASHP’s) multi-year effort to educate policymakers about the public health crisis caused by drug shortages came to fruition when President Obama signed the “The Food and Drug Administration Safety and Innovation Act.” The new law includes several ASHP-supported provisions to minimize the impact of drug shortages on patients. Please view this timeline to follow how ASHP and our partners worked with legislators to develop the drug shortages provisions in the legislation, which also reauthorizes funding for the Prescription Drug User Fee Act.
1999
First Meeting with FDA
ASHP staff met with Food and Drug Administration (FDA) officials to discuss the growing problem of drug shortages.
View on timeline2000
Creation of Drug Shortages Resource Center
The initial launch of the online resource center only featured critical shortages.
View on timeline2001
Partnership with University of Utah Drug Information Services Begins
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.
View on timeline2001
Drug Shortages Guideline Published
The ASHP Guideline on Managing Drug Product Shortages was first published in 2001 to help practitioners navigate the challenges posed by shortages.
View on timeline2002
ASHP-AMA Convene Stakeholders Meeting
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.
View on timeline2003
Meeting with HHS Officials
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.
View on timeline2003
ASHP-Johns Hopkins-University of Wisconsin Survey
ASHP partners with Johns Hopkins Hospital and University of Wisconsin on national survey of the impact of drug shortages in acute care hospitals.
View on timeline2003
HDMA Drug Shortages Task Force
ASHP participates in a Drug Shortages Task Force convened by the Healthcare Distribution Management Association (HDMA)
View on timeline2009
Drug Shortages Guidelines Updated
Guidelines on Managing Drug Product Shortages updated to include new strategies for managing drug shortages.
View on timeline2010
Multidisciplinary Stakeholder Summit
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
View on timeline2010
ASHP Meets with FDA Office of Drug Shortages
ASHP and staff from FDA Office of Drug Shortages meet to discuss potential areas of collaboration.
View on timeline2010
Open Forum at Midyear Clinical Meeting
Open Forum during ASHP Midyear Clinical Meeting to educate members on the Society’s efforts to address drug shortages.
View on timeline2010
Meeting with Senator Klobuchar
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.
View on timeline2011
Klobuchar Introduces Drug Shortages Bill
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).
View on timeline2011
Work Group Looks at Legislative, Regulatory Fixes
Work groups formed as part of the 2010 Drug Shortages Summit begin work on recommendations for legislative and regulatory action.
View on timeline2011
House Version of Drug Shortages Bill Introduced
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.”
View on timeline2011
ASHP and AHA Report Key Findings
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.
View on timeline2011
White Paper Published in FDLI Journal
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.
View on timeline2011
Roundtable with HHS Officials
ASHP participates in roundtable with Kathleen Sebelius, Secretary of the Department of Health and Human Services and FDA Commissioner Margaret Hamburg
View on timeline2011
FDA Public Workshop
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.
View on timeline2011
Members Lobby Congress on Drug 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
View on timeline2011
ASHP Members Testify during Congressional Hearing
ASHP members Kevin Colgan and Richard Paoletti testified before the Health subcommittee of House Energy and Commerce Committee
View on timeline2011
President Issues Executive Order
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.
View on timeline2011
ASHP Urges Congress to take Deeper Look at Causes of Drug Shortages
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.
View on timeline2011
ASHP Shares Patient Safety Concerns During Senate Hearing
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.
View on timeline2012
Greene Gives Congress Caregivers' Perspective
ASHP member William Greene described the challenges drug shortages cause for caregivers during a hearing held by the House Energy and Commerce Committee.
View on timeline2012
Coalition Urges Congress to Improve Drug Shortages Bill
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.
View on timeline2012
Drug Shortages Bills Included in FDA Funding Bill
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).
View on timeline2012
Ad Campaign Urges Congress to Include Strong Drug Shortages Provisions
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.
View on timeline2012
Senate Passes S.3187
The Senate passed “The FDA Innovation and Safety Act "(S. 3187), which included strong drug shortages provisions by a nearly unanimous vote.
View on timeline2012
House Passes FDA Reform Act
The House of Representatives passed the Food and Drug Administration Reform Act (H.R. 5651) 387-5.
View on timeline2012
Senate Passes Drug Shortages Legislation
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.
View on timeline2012
Drug Shortages Bill Becomes Law
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.
View on timeline
