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# Peters Wants Drug Shortage Answers
- URL: https://www.fdaweb.com/peters-wants-drug-shortage-answers/
- Published: 2019-08-21T12:00:00.000Z
- Updated: 2026-09-15T01:45:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144826

Sen. **Gary Peters** (D-MI), ranking member on the Senate Homeland Security and Governmental Affairs Committee, is asking FDA acting commissioner **Ned Sharpless** for information about ongoing drug shortages and current and planned agency actions to address the situation. In an 8/21 [letter](https://www.hsgac.senate.gov/imo/media/doc/2019-08-21%20GCP%20Letter%20on%20FDA%20Drug%20Shortage%20Report%20and%20Investgation.pdf?ref=fdaweb.com), Peters says the number of active shortages in the first half of 2019 alone (282) already exceeds the number of shortages at any point in 2018, according to the American Society of Health-System Pharmacists.

“Drug shortages are causing devastating health and economic consequences for patients, hospitals, and consumers,” Peters writes. He says he appreciates and recognizes the measurable steps FDA has taken to address drug shortages, including the prevention of 145 drug shortages in 2017, expanded and expedited review and approval processes for drugs that are in shortage, public disclosure of drugs that are off-patent and lack generic competition, and implementation of the Agency Drug Shortages Task Force.

“Though laudable,” he says, “these efforts are unfortunately not sufficient given the current state of rising drug shortages in our nation. In addition to the concerns identified above, I am increasingly concerned FDA may not have the data it needs to adequately assess and mitigate drug shortages.”

Peters asks Sharpless to: 

- provide the estimated publication date for the agency’s Report on Drug Shortages for Calendar Year 2018;
- discuss follow-up actions taken as a result of an 11/27/18 FDA public meeting to address root causes of drug shortages and enduring solutions;
- detail all Agency Drug Shortages Task Force actions since 7/2018 to mitigate drug shortages as well as plans and goals to address ongoing drug shortages;
- provide a description of planned and anticipated impacts, as well as safety considerations, under Pathways 1 and 2 of the agency’s Safe Importation Action Plan;
- describe the information manufacturers voluntarily provide to FDA as part of its efforts to address underlying causes of drug shortages, including whether manufacturers provide information about industry consolidation, decisions by manufacturers to limit production of inexpensive drugs with low profit margins, manufacturers’ location, duration of shortages, sources of raw materials, and shortage causes; and
- describe any limitations in Sharpless’ authority as acting commissioner and any non-delegable commissioner duties, including those relevant to addressing and mitigating drug shortages.