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BIO Comments on FDA Guidance for Risk Management Plans to Mitigate the Potential for Drug Shortages

August 31, 2022

Today, BIO submitted comments in response to the FDA’s recent draft guidance on the development, maintenance, and implementation of Risk Management Plans (RMPs). While the comment letter expressed broad support for the systematic approach for establishing risk management plans (RMPs) laid out in the draft guideline, BIO also conveyed serious concerns related to the scope and timing of the guideline. For example, one critical concern is the guidance’s introduction of the terms and definitions of “primary stakeholder”, “secondary stakeholder” and “other stakeholder” to describe “manufacturer” in FD&C section 506C(a). These stakeholder definitions are very broad and could be interpreted that manufacturers of any step in the active pharmaceutical ingredient (API) or drug product manufacturing process need to prepare RMPs for the designated products. Additionally, BIO pointed out that the language used throughout the guidance to define covered products (i.e., life-supporting, life-sustaining, etc.) are subject to interpretation from individual manufacturers. Likewise, BIO noted the use of the term API (active pharmaceutical ingredient) in the guidance, which usually applies only to small molecule drugs, rather than the more inclusive term “drug substance.” Next, BIO stated concerns that neither the draft guideline nor the Federal Register notice provides a timeline for implementation of the final guideline. In response, BIO requested a period of at least two years from publication of a final guideline before FDA reviews RMPs during inspections or as part of a 704(a)(4) records request. Finally, BIO expressed concerns for the overly prescriptive recommendations contained within Section III-C along with the language on information sharing contained within Section IV-A. 

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BIO Comments on FDA Guidance - RMPs to Mitigate Drug Shortages
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