ASH submitted comments to the Senate Committee on Health, Education, Labor, and Pensions (HELP) on draft legislation concerning prescription drug shortages. The draft bill is similar to other Congressional legislation ASH has endorsed and would create a mandatory "early warning system" that requires manufacturers to provide early notification to 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.
ASH offered the following recommendations to strengthen the legislation:
- Radio pharmaceutical drug products, a human tissue replaced by a recombinant product, and products derived from human plasma protein should be included in the reporting requirement.
- All biologics and biosimilar products should be included within the defined parameters for reporting.
- A strong enforcement mechanism that instructs the Secretary to establish civil monetary penalties for failure to submit a required notification should be established.
- The legislation should include a provision for the Committee to work with stakeholders to ensure the defined reporting parameters cannot be misinterpreted to inadvertently exclude critical hematology drugs.
- The proposed Task Force on Drug Shortages should include hematologist and patient advocates and the Task Force should be required to consider the impact of drug shortages on federally-sponsored clinical trials.
- The legislation require the Secretary of Health & Human Services develop a plan on how the FDA will improve its communication and distribution of information about drug shortages to physician and patient organizations.
- A study on the feasibility of developing a national contingency plan for drug shortages should be considered.
- Separate Congressional authorization for the FDA's Drug Shortage Program should be created to provide adequate funding levels to carry out the activities authorized by this legislation.
In addition to submitting the Society's comments, ASH also joined with other health care provider and cancer-related coalitions to submit additional comment letters.
It is expected that drug shortage legislation will be incorporated into a larger bill known as the Prescription Drug User Fee Act (PDUFA) rather than being passed individually. Lawmakers in the House of Representatives have also introduced similar drug shortage legislation as part of a draft user fee bill. The PDUFA legislation is expected to be considered over the next few months in the House and Senate.
As Congress considers the PDUFA legislation, 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 email@example.com.
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