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Regulatory requirements of the Food and Drug Administration would preclude product claims based on observational research.
Health Aff (Millwood). 2012 Oct; 31(10):2188-92.HA

Abstract

As norms of comparative effectiveness research are sought within the biomedical and health care communities, and the science of conducting and interpreting this research develops, the Food and Drug Administration (FDA) must balance diverse interests. The agency's overarching interest is the development of high-quality comparative effectiveness information that contributes to improved patient care. To further this interest, the FDA can provide expertise in trial design and postmarketing surveillance. The FDA can also ensure that manufacturers of medical products use comparative effectiveness information in product promotion in a manner consistent with regulatory requirements. In this article we observe that these requirements would preclude the manufacturer's use in a promotional context of comparative effectiveness findings derived from an observational study. The FDA recognizes, however, that there are ongoing efforts to address the methodological problems inherent in observational approaches and to foster consensus on enhanced methods. The FDA must work to navigate challenges that relate to both the science of comparative effectiveness research and the agency's statutory responsibilities to the public health.

Authors+Show Affiliations

Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. Joseph.Griffin@fda.hhs.govNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23048095

Citation

Griffin, Joseph P., et al. "Regulatory Requirements of the Food and Drug Administration Would Preclude Product Claims Based On Observational Research." Health Affairs (Project Hope), vol. 31, no. 10, 2012, pp. 2188-92.
Griffin JP, Godfrey BM, Sherman RE. Regulatory requirements of the Food and Drug Administration would preclude product claims based on observational research. Health Aff (Millwood). 2012;31(10):2188-92.
Griffin, J. P., Godfrey, B. M., & Sherman, R. E. (2012). Regulatory requirements of the Food and Drug Administration would preclude product claims based on observational research. Health Affairs (Project Hope), 31(10), 2188-92. https://doi.org/10.1377/hlthaff.2012.0958
Griffin JP, Godfrey BM, Sherman RE. Regulatory Requirements of the Food and Drug Administration Would Preclude Product Claims Based On Observational Research. Health Aff (Millwood). 2012;31(10):2188-92. PubMed PMID: 23048095.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Regulatory requirements of the Food and Drug Administration would preclude product claims based on observational research. AU - Griffin,Joseph P, AU - Godfrey,Bryant M, AU - Sherman,Rachel E, PY - 2012/10/11/entrez PY - 2012/10/11/pubmed PY - 2013/3/15/medline SP - 2188 EP - 92 JF - Health affairs (Project Hope) JO - Health Aff (Millwood) VL - 31 IS - 10 N2 - As norms of comparative effectiveness research are sought within the biomedical and health care communities, and the science of conducting and interpreting this research develops, the Food and Drug Administration (FDA) must balance diverse interests. The agency's overarching interest is the development of high-quality comparative effectiveness information that contributes to improved patient care. To further this interest, the FDA can provide expertise in trial design and postmarketing surveillance. The FDA can also ensure that manufacturers of medical products use comparative effectiveness information in product promotion in a manner consistent with regulatory requirements. In this article we observe that these requirements would preclude the manufacturer's use in a promotional context of comparative effectiveness findings derived from an observational study. The FDA recognizes, however, that there are ongoing efforts to address the methodological problems inherent in observational approaches and to foster consensus on enhanced methods. The FDA must work to navigate challenges that relate to both the science of comparative effectiveness research and the agency's statutory responsibilities to the public health. SN - 1544-5208 UR - https://www.unboundmedicine.com/medline/citation/23048095/Regulatory_requirements_of_the_Food_and_Drug_Administration_would_preclude_product_claims_based_on_observational_research_ L2 - https://www.healthaffairs.org/doi/10.1377/hlthaff.2012.0958?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -