ASH advocacy on drug shortages is making a difference as the Senate considers drug shortage legislation as part of their review of a larger bill known as the Prescription Drug User Fee Act (PDUFA). On April 25, the Senate Committee on Health, Education, Labor, and Pensions (HELP) marked-up and approved its version of the PDUFA legislation, which includes prescription drug shortages provisions. The drug shortage portion of the legislation would create a mandatory "early warning system" that requires manufacturers to provide early notification to Food and Drug Administration (FDA) of a discontinuance or "meaningful disruption" of drugs which are life-supporting, life-sustaining or used in the prevention of a debilitating disease or condition. Additionally, the legislation would establish a federal taskforce to mitigate and prevent drug shortages; develop record-keeping criteria to study the impact of drug shortages and related trends; provide the FDA with greater authority to expedite reviews of drugs and inspections of facilities; and direct the HHS Secretary and a working group to perform a study on drug shortages to review stockpiling, price gouging and gray market activities.
ASH has been working closely with the HELP Committee leaders throughout the development of the drug shortage legislation. The Society met with Senate staff and submitted comments to further strengthen the legislation. Several of ASH's recommendations were incorporated into the bill, including:
- Including sterile injectable products within the definition;
- Requiring that the Secretary to disseminate information about drug shortages to patient and provider organizations;
- Requiring enhanced inter and intra agency coordination and requiring increased and effective communication with outside stakeholders; and
- Requiring that the Strategic Plan consider the impact of drug shortages on research and clinical trials.
ASH continues to advocate for the following enhancements to the legislation:
- Including radio pharmaceutical drug products, a human tissue replaced by a recombinant product, and products derived from human plasma protein in the reporting requirement.
- Including all biologics and biosimilar products within the defined parameters for reporting.
- Providing civil monetary penalties for failure to submit a required notification.
- Requiring a study on the feasibility of developing a national contingency plan for drug shortages.
- Creating a set-a-side in FDA funding to provide adequate funding levels to carry out the activities authorized by this legislation.
The Senate is expected to consider drug shortage legislation in May. Lawmakers in the House of Representatives have also introduced similar drug shortage legislation and are expected to consider it in May.
It is critical that Members of Congress hear from their physician constituents about the need to support drug shortage legislation. All ASH members are encouraged to participate in the Society's advocacy efforts to combat drug shortages by visiting the ASH Advocacy Center today.
Read more information about the status of hematologic drug shortages, ASH advocacy efforts, and resources for physicians dealing with shortages. If you have any additional questions and/or concerns about any hematologic drug shortages, please contact ASH Government Relations Manager, Stephanie Kaplan at 202-776-0544 or firstname.lastname@example.org.
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