FACT Professional Relations Committee Collaborates on Input to Regulatory Agencies in the United States
Member organizations of the FACT Professional Relations Committee have robust advocacy programs that initiate and respond to legislative and regulatory affairs around the world. They report on their activities on a quarterly basis during committee meetings. Occasionally, there are proposals for which the committee feels concerted efforts are necessary, and the member organizations collaborate to submit comments or express support. The committee worked on two such proposals in the second half of 2023.
Support for the Life Saving Leave Act (H.R. 3024)
Be the Match led an effort to express support for the Life Saving Leave Act (H.R. 3024), which ensures bone marrow and blood stem cell donors nationwide have up to 40 non-consecutive, unpaid hours of leave without a risk to their jobs. Most patients in need of blood and marrow transplantation have only one match on the nation’s bone marrow registry, but job-related barriers to donation can prevent patients from receiving the transplant. One of the top-cited obstacles to saying “yes” to being a donor are job-related barriers.
Many member organizations of the Professional Relations Committee signed on to a statement of support for the Act. Via the statement, the widespread support of this bill was shared through the American Society for Transplantation and Cellular Therapy (ASTCT)’s Day on the Hill on Sept. 14.
Comments in Response to the FDA Proposed Rule on Laboratory Developed Tests
As reported in a previous article, the Professional Relations Committee has followed efforts to change Food and Drug Administration (FDA) oversight of laboratory-developed tests (LDTs). The FDA currently practices enforcement discretion for these tests, but seeks to phase out the discretion approach and begin requiring approval under medical device regulations.
The committee thanks everyone who participated in the request for extending the public comment period. The FDA declined this suggestion, and comments were due on December 4. Several member organizations shared their general impressions regarding the proposed rule, and then submitted individual organizational comments to the FDA.
FACT’s comments expressed appreciation to the FDA for its commitment to public health, stated that the proposed rule broadly combines a diverse number of LDTs into a single approach, and suggested that the current proposal should be revised to apply to large-volume, mass-produced, and direct-to-consumer tests that are IVDs offered as LDTs. This is where the greatest potential risks, and the greatest potential gains, to public health are present. FACT also specifically suggested that general enforcement discretion be continued for LDTs utilized by clinical laboratories at accredited hospitals and health care systems to support the provision of hematopoietic cell transplantation and cell and gene therapy, including post-therapy monitoring tests and off-label use of FDA-approved test kits and devices. These tests are often used in urgent, life-saving situations and utilize innovative techniques to facilitate the delivery of new therapies with new side effects. Narrowing the scope of the proposed rule would mitigate risks to patient access to therapies and continue prompt intervention of side effects. This approach would substantially benefit public health while avoiding a tumultuous phaseout approach for a wide variety of tests in scale and purpose.
FACT-accredited programs can rest assured that their interests are well represented; however, the specific input of individual experts cannot be understated. FACT announces situations in which it feels that diverse submissions are necessary to fully explain the impact of proposed legislation and regulations, and we encourage you to take advantage of those opportunities to influence future requirements.