The Association for Clinical Oncology (ASCO) submitted comments to the Food and Drug Administration (FDA) in response to its Proposed Rule – Annual Summary Reporting Requirements Under the Right to Try Act, which proposes a statutory requirement where sponsors and manufacturers must provide an annual summary of any investigational drugs supplied for use to an eligible patient.
ASCO offers recommendations on the annual summary content areas FDA is proposing for inclusion in the summary reports, including:
- Number of Doses Supplied – ASCO believes that the number of doses per patient is more useful to report than the aggregate number of doses supplied across all patients. Therefore, ASCO suggests that the agency require the reporting of the more detailed information suggested by the Association.
- Number of Patients Treated - ASCO encourages FDA to also require information on patient key demographics, such as age, disease, and comorbidities, in the annual summaries as demographic information is necessary in understanding the use of therapies outside the usual clinical trial population.
- Any Known Serious Adverse Events and Outcomes - ASCO applauds the agency for proposing to require any known serious adverse events, including outcomes of such events, experienced by patients treated under the Right to Try Act since reporting all adverse events will be informative for the Agency, clinicians, and other stakeholders. Additionally, ASCO supports the Agency’s proposal for manufacturers to use common medical terminology included in the Medical Dictionary for Regulatory Activities (medDRA).
ASCO believes the transparency of these proposed reports under the Right to Try Act is critical to understanding the use of investigational drugs and agrees that these reports may increase awareness of investigational drugs, the diseases or conditions for which patients are seeking access, and patient safety concerns that may result from such use.
Read the full comment letter.
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