Clinicians

Hematologic Drug Shortage Information

Sep 21
  
2023

ASH continues to work with Congress, federal agencies, and other stakeholders to ensure continued access to safe and effective hematologic drugs.

New Updates on Hematologic Drug Shortages

Drug shortages are reaching an all-time high in the United States, especially in hematology care.  ASH continues to keep members apprised of shortages as well as actively engage with Congress, federal agencies, including recent discussions with U.S. Food and Drug Administration (FDA), and other stakeholders to ensure continued access to safe and effective hematologic drugs.  Please see below the recent hematologic shortages, the Society’s actions, and ways for members to get involved.

Recent Hematologic Drug Shortages

  • Carboplatin Injection, Cisplatin Injection, and Methotrexate Injection
    • There are five approved manufacturers for all three of these products.
    • One manufacturer, Accord, made the decision to place all inventory on hold pending further assessment following an inspection of their plant in India that uncovered quality-related issues.
    • The FDA is working with Accord to resume availability following their assessments – cisplatin has been released following assessment and carboplatin and methotrexate planned to follow soon.
    • The FDA is working with the alternate manufacturers to ramp up, as well as:
      • Exploring temporary importation*; and
      • Requesting data from the manufacturers to support additional dating for lots in distribution nearing or past expiry.
    • The FDA has worked with Qilu Pharmaceuticals and Apotex Corp. to temporarily import cisplatin to help meet patient needs during the shortage.*
    • (Updated 7/13/23) There is a new supply from FDA approved manufacturer Gland available starting the third week of July from their distributor Sagent.
  • Fludarabine Phosphate Injection
    • There are two manufacturers marketing in the US – Teva and Fresenius Kabi – both experienced delays last year.
    • Areva, an approved manufacturer was granted regulatory discretion for distribution of product with unapproved active pharmaceutical ingredient (API) while they worked to get the new supplier qualified under their application.
    • Accord was temporarily allowed to import unapproved product from Canada*.
    • The FDA is continuing to work on additional supply options to resolve this shortage.
  • Penicillin G Benzathine Injectable Suspension
    • Bicillin LA as well as Bicillin C-R are solely sourced from Pfizer and experiencing increased demand.
    • Oral Pen V K remains available, however firms report experiencing increased demand.

    • *To address critical drugs shortages, the FDA has worked with pharmaceutical companies to temporary import therapies to help meet patient needs during the shortage. In this situation, the FDA very carefully assesses the overseas product for quality, making sure that its safe for U.S. patients. Please see the entry in the FDA’s drug shortages database as well as the “Dear Health Care Provider” letter regarding this action. The FDA will continue all efforts with the approved manufacturers in addition to any potential importation actions to meet all patient needs for the oncology drugs impacted by shortages. 

Recent Comments to Congress and the FDA

ASH SUBMITS COMMENTS TO CONGRESSIONAL LEADERS ON DRUG SHORTAGES

On September 13, ASH sent a letter to Congressional leaders about the need for timely and comprehensive action on drug shortages, including those that impact hematology care.

ASH SUBMITS COMMENTS TO HOUSE ENERGY AND COMMERCE COMMITTEE ON THE STOP DRUG SHORTAGES ACT DISCUSSION DRAFT

In late August, ASH sent a letter to Representative Cathy McMorris Rodgers (R-WA-5), Chair of the House Energy & Commerce Committee, recommending changes to draft legislation entitled Stop Drug Shortages Act.

ASH Letter re: FDA Draft on Considerations for Externally Controlled Trials for Drug and Biological Products

On May 1, ASH submitted a comment letter to the U.S. Food and Drug Administration (FDA) Commissioner, Dr. Robert M. Califf in response to the agency's draft guidance on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (Docket Number: 2022-D-2983)

ASH Joins Coalition Letter Supporting Robust Discretionary Funding in FY 2024

On May 15, ASH joined more than 750 organizations in a letter urging congressional leaders to provide robust investments in nondefense discretionary (NDD) programs in fiscal year (FY) 2024. Examples of NDD programs include the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and other federally funded health and science programs.

ASH Senate Appropriations FY 2023 Written Statement

On May 18, ASH submitted a statement to the Senate Appropriations Subcommittee on Labor, Health and Human Services (HHS), Education, and Related Agencies (Labor-HHS) urging support for increased funding for the National Institutes of Health (NIH) and other federal public health programs, including the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA), in fiscal year (FY) 2024.

ASH Comments to FDA Draft on Considerations re: Accelerated Approval of Oncology Therapeutics

On May 25, ASH sent a comment letter to the U.S. Food and Drug Administration (FDA) in response to the Agency’s Draft Guidance on Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics.

ASH Letter on FDA Draft re: Capturing Post-Approval Efficacy Data on Cell and Gene Therapies

ASH submitted a follow-up letter to FDA in late May with additional details about the ASH RC Data Hub; recommendations from the ASH and RC and Innovative Genomics Institute initiative on “Accelerating Innovations for Sickle Cell Disease with Real-World Evidence;” and ASH’s work focused on Emerging Gene and Cell Therapies.

Take Action to Address Drug Shortages in Hematology and Oncology Care!

We need you to reach out to your elected officials and to urge Congress to examine how to help address drug shortages that are reaching an all-time peak. ASH understands that the causes of drug shortages are multiple and complex and that there is not a single solution. As different remedies are considered, it is important for Congress to hear about the impact these shortages are having on patient care and the need for Congress to work with the Food and Drug Administration (FDA) and stakeholders to help prevent or mitigate future drug and medical device shortages.

Act Now

Current Hematologic Drug Shortages

Discontinued Hematologic Drugs

Resolved Hematologic Drug Shortages

Additional Resources

ASH's Comments to Congress and the U.S. Food and Drug Administration

Media Coverage of Drug Shortages

For more information or to notify ASH of drug recalls or shortages, please contact Katherine Stark at [email protected]. 

Citations