Tags

Type your tag names separated by a space and hit enter

FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment.
Food Drug Law J. 2009; 64(3):577-98.FD

Abstract

This article provides a summary of the expansion of FDA's discretionary authority in the post-9/11 period, particularly with respect to FDA's authority to monitor and publicize potential health risks linked to food, dietary supplements, nonprescription drugs, and other consumer health products. In addition, this article evaluates the need for FDA to establish procedural safeguards to reduce the significant risks of unintended and undue harm to people and regulated companies that can result from adverse publicity in the more "transparent" post 9/11 FDA regulatory environment. Specifically, Part I summarizes the amendments to the FDCA enacted during the post-9/11 period that have expanded FDA's postmarket authority to monitor, evaluate, and publicize potential health risks linked to food, dietary supplements, nonprescription drugs and other consumer health products marketed in the United States, in conjunction with FDA's Sentinel Initiative, Reportable Food Registry, and other adverse event reporting requirements. Part II discusses the convergence of FDA's expanded postmarket authority to publicize product-related risks with President Obama's transparency initiative aimed at fostering "open government" through increased public access to government information. In addition, Part II considers the nature of the procedural safeguards needed in the post-9/11 FDA regulatory environment, in view of FDA's historical record and illustrative cases that help expose how adverse "transparency" surrounding FDA warning letters, recalls and safety alerts concerning products in the marketplace can have undue and unintended prejudicial and harmful effects for the people and companies that are legally responsible for such products. Finally, based on these analysis, this article concludes with some observations concerning the nature of the procedural safeguards needed to reduce the significant risks of "transparency" policy harms in the pos-9/11 regulatory environment.

Authors+Show Affiliations

Kelley Drye & Warren LLP, Washington, D.C., USA.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

19999646

Citation

Roller, Sarah Taylor, et al. "FDA's Expanding Postmarket Authority to Monitor and Publicize Food and Consumer Health Product Risks: the Need for Procedural Safeguards to Reduce "transparency" Policy Harms in the Post-9/11 Regulatory Environment." Food and Drug Law Journal, vol. 64, no. 3, 2009, pp. 577-98.
Roller ST, Pippins RR, Ngai JW. FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment. Food Drug Law J. 2009;64(3):577-98.
Roller, S. T., Pippins, R. R., & Ngai, J. W. (2009). FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment. Food and Drug Law Journal, 64(3), 577-98.
Roller ST, Pippins RR, Ngai JW. FDA's Expanding Postmarket Authority to Monitor and Publicize Food and Consumer Health Product Risks: the Need for Procedural Safeguards to Reduce "transparency" Policy Harms in the Post-9/11 Regulatory Environment. Food Drug Law J. 2009;64(3):577-98. PubMed PMID: 19999646.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment. AU - Roller,Sarah Taylor, AU - Pippins,Raqiyyah R, AU - Ngai,Jennifer W, PY - 2009/12/17/entrez PY - 2009/12/17/pubmed PY - 2009/12/23/medline SP - 577 EP - 98 JF - Food and drug law journal JO - Food Drug Law J VL - 64 IS - 3 N2 - This article provides a summary of the expansion of FDA's discretionary authority in the post-9/11 period, particularly with respect to FDA's authority to monitor and publicize potential health risks linked to food, dietary supplements, nonprescription drugs, and other consumer health products. In addition, this article evaluates the need for FDA to establish procedural safeguards to reduce the significant risks of unintended and undue harm to people and regulated companies that can result from adverse publicity in the more "transparent" post 9/11 FDA regulatory environment. Specifically, Part I summarizes the amendments to the FDCA enacted during the post-9/11 period that have expanded FDA's postmarket authority to monitor, evaluate, and publicize potential health risks linked to food, dietary supplements, nonprescription drugs and other consumer health products marketed in the United States, in conjunction with FDA's Sentinel Initiative, Reportable Food Registry, and other adverse event reporting requirements. Part II discusses the convergence of FDA's expanded postmarket authority to publicize product-related risks with President Obama's transparency initiative aimed at fostering "open government" through increased public access to government information. In addition, Part II considers the nature of the procedural safeguards needed in the post-9/11 FDA regulatory environment, in view of FDA's historical record and illustrative cases that help expose how adverse "transparency" surrounding FDA warning letters, recalls and safety alerts concerning products in the marketplace can have undue and unintended prejudicial and harmful effects for the people and companies that are legally responsible for such products. Finally, based on these analysis, this article concludes with some observations concerning the nature of the procedural safeguards needed to reduce the significant risks of "transparency" policy harms in the pos-9/11 regulatory environment. SN - 1064-590X UR - https://www.unboundmedicine.com/medline/citation/19999646/FDA's_expanding_postmarket_authority_to_monitor_and_publicize_food_and_consumer_health_product_risks:_the_need_for_procedural_safeguards_to_reduce_"transparency"_policy_harms_in_the_post_9/11_regulatory_environment_ L2 - https://medlineplus.gov/biodefenseandbioterrorism.html DB - PRIME DP - Unbound Medicine ER -