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# Concerns About Drug Shortage Draft Guidance
- URL: https://www.fdaweb.com/concerns-about-drug-shortage-draft-guidance/
- Published: 2022-08-10T12:00:00.000Z
- Updated: 2026-09-14T17:55:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152479

The Biosimilars Forum says it is concerned that an FDA draft guidance on risk management plans (RMP) to mitigate the potential for drug shortages “is not well tailored to achieving this purpose.” The forum’s 8/4 comment [letter](https://downloads.regulations.gov/FDA-2022-D-0277-0012/attachment%5F1.pdf?ref=fdaweb.com) says the draft guidance “is not consistent with the law and will impose a heavy burden on industry that will undermine the desired objective of mitigating shortages, and may actually exacerbate them.” The letter says the forum urges FDA to adopt an approach to supply RMPs consistent with the statute and International Conference on Harmonization Q9 principles that affords companies the flexibility to leverage their existing supply chain processes and develop an RMP that best suits individual companies’ business models and needs.

In its [comment](https://downloads.regulations.gov/FDA-2022-D-0277-0013/attachment%5F1.pdf?ref=fdaweb.com), Vizient says it appreciates the numerous steps FDA outlines in the draft that may help support quality and redundancy, and encourages the agency to consider opportunities to increase transparency and the production of additional supply.