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Pediatrics: BIO Comments on FDA Draft Guidance Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products – Content and Format

September 28, 2020

September 27, 2020

Re: Docket No. FDA-2014-D-1551:  FDA Draft Guidance, Pregnancy, Lactation, and Reproductive Potential:  Labeling for Human Prescription Drug and Biological Products – Content and Format.

Dear Sir/Madam:

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the Draft Guidance, Pregnancy, Lactation, and Reproductive Potential:  Labeling for Human Prescription Drug and Biological Products – Content and Format.

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

BIO appreciates the Agency’s inclusion of the pregnancy registry and the risk summary in the label to ensure awareness and encourage Health Care Provider (HCP)-patient conversations.  BIO has two overarching comments on this guidance.  Firstly, it is not clear from the guidance whether sponsors can utilize the pregnancy and lactation data as supportive safety data generated from other drugs that are in the same drug class or possess the same drug molecular structure with representative justification.  It would be helpful if the Agency could provide clarification as to whether this data would be accepted to demonstrate safety for pregnant and lactating women.  Secondly, since pregnancy studies and lactation studies are rarely conducted pre-approval and given the Agency’s prioritization of initiatives focused on use of real world evidence, it would be helpful if the Agency could provide recommendations on utilizing post-marketing real world data to support labeling updates for pregnancy and lactation sections.  BIO has included in this letter several comments and recommendations for FDA’s consideration in finalizing this guidance.

Listing Non-Sponsor Registries

BIO believes that the registry’s listed should be limited to those registries which are endorsed/sponsored or accepted by the sponsor. In some therapeutic areas, there are registries that are not endorsed or sponsored by the drug developer, but that capture drug exposure information. These registries that are not endorsed or sponsored by the drug developer may be scientifically meaningful but uninformative in relation to the specific product concerns and therefore may be confusing to patients and providers if listed. 

Specifically, data captured in registries that are not endorsed or sponsored by the drug developer is often not collected in a way that:

  • Meaningfully or measurably informs understanding of benefit-risk profiles rendering the data uninformative to meet FDA needs/ requirements.
  • Ensures/ enables rigorous and consistent application of inclusion criteria for patients/ pregnancies in a prospective manner consistent with the sponsor's registry.
  • Enables data to be combined with patients from other registries with the same data elements and units of measures such that an analysis of data can occur with multiple sources.
  • Ensures that consent for registry participation by registry participants and curators include the sharing, analysis, and reporting of data by a designated partner and with the product sponsor.
  • Enables deduplication of patients in a multi-source analysis.

Listing non-sponsor registries in addition to the one for which the sponsor is accountable could mean the many patients unknowingly choose to enroll in a non-sponsored registry where data collected does not adequately inform the safety risk-benefit profile or is inaccessible for the necessary analysis.  Third party registries also may have financial support/resourcing models that are not tied to the oversight of a sponsor and can be terminated (or qualitatively diminished) for reasons outside of the sponsor's control, potentially jeopardizing the sponsors ability to fulfill requirements or inform patients/ HCPs about pregnancy related safety.

For these reasons, BIO advocates for the presentation of only sponsored or "authorized" registries that are supported in a way that ensures fulfillment of regulatory commitments in a drug label.  BIO encourages the Agency to keep inclusion of the sponsor's designated registry(ies)/study(ies) in the final guidance. 

BIO appreciates this opportunity to submit comments regarding FDA’s Draft Guidance, Pregnancy, Lactation, and Reproductive Potential:  Labeling for Human Prescription Drug and Biological Products – Content and Format.  We would be pleased to provide further input or clarification of our comments, as needed.

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BIO Comments on Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products
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