Drugmakers and industry groups are calling on the FDA to hold off on finalizing a draft guidance until the International Council on Harmonisation (ICH) finalizes its own guidance on the topic of reproductive toxicity testing for oncology drugs.
Comments were released last week on the FDA draft guidance from late September.
Industry group PhRMA and Merck both called on the FDA to ensure consistency between the draft guidance and relevant ICH guidelines, and urged FDA to wait until ICH S5(R3) is endorsed at Step 4 of the ICH process.
“PhRMA believes that the guidance including the proposed changes that is consistent with the relevant ICH guidelines would better inform drug development, improve access to new therapies for patients, and advance public health, while protecting patient safety,” the industry group’s comment said, also calling for alignment with ICH S9 and S9 Q&A, S6(R1) and ICH M3(R2) and M3 Q&A.
Merck added: “With regard to conducting an embryo-fetal development (EFD) study, including for drug-drug combinations, and with regard to generating placental transfer data (after obtaining in vitro data), we also find these to be critical topics that need Agency clarification of the circumstances for when such EFD studies and placental transfer data must be provided. Additionally, for stand-alone fertility studies, it will be important for industry to know what FDA considers to be the ‘totality of data’ on which to determine whether such a fertility study is needed.”
Celgene, meanwhile, sought clarification on whether the two genotoxicity assays needed to conclude a product is genotoxic “should assess the same endpoint or different endpoints (e.g., mutagenicity and clastogenicity). We would also like to confirm if an in vivo assessment is required as one of the two assays.”
And Novartis noted that many of the FDA-approved pregnancy and lactation labeling (PLLR) compliant United States Product Inserts (USPIs) do not follow the labeling recommendation set out in the draft guidance.
Novartis also sought clarification “regarding when two EFD studies are available (one from each compound) and neither has demonstrated teratogenicity/embryo-fetal lethality, a combination EFD study should not be needed (based on knowledge/evidence of no synergy between the two compounds).”
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email firstname.lastname@example.org for more information.
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