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# Congress Should Do More on Drug Shortages: Analysis
- URL: https://www.fdaweb.com/congress-should-do-more-on-drug-shortages-analysis/
- Published: 2023-11-14T12:00:00.000Z
- Updated: 2026-09-14T14:16:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155791

Manhattan Institute senior fellow **Randall Lutter**, a former FDA senior scientific and regulatory advisor, says there are many steps Congress should be taking to have a fuller understanding of drug shortages and to hold FDA accountable for its actions. In an [*Issue Brief*](https://manhattan.institute/article/widespread-chronic-drugs-shortages-demand-congressional-action?ref=fdaweb.com), Lutter says congressional Democrats and Republicans have widely differing views on legislation needed to address drug shortages but none of the proposals would require better accounting by FDA of its efforts to identify and alleviate shortages, although the agency “now provides little data regarding such efforts.”

He also says none of the legislative proposals would authorize or facilitate imports of finished drugs from abroad to alleviate shortages in the U.S., even though FDA now encourages such imports as part of its response to shortages. “Congress should remedy these oversights,” Lutter declares.

He says that drug shortages are worse than they appear and are caused by multiple factors. “FDA does not identify shortages in a coherent way,” Lutter writes, “hindering public understanding of shortages and efforts by FDA and others to prevent and alleviate them.”

He says Congress should require an independent evaluation of FDA’s program of identifying and responding to shortages, including:

- an assessment of the timeliness of FDA’s listing and delisting of drugs and biologics in shortage;
- an assessment of the effectiveness of FDA’s response to short-term shortages;
- an assessment of the effectiveness of FDA’s response to especially severe shortages;
- an analysis of the effectiveness of select shortage mitigation measures; and
- an analysis of trends in the numbers of drugs and biologics in shortage.

To facilitate the importation of generic drugs from select foreign countries, Lutter says, Congress should:

- identify select countries with adequate drug volume and trusted regulators of drug safety and efficacy;
- identify the set of generic drugs at high risk of shortage in the U.S.;
- require FDA and its counterparts in select countries to share electronic access to the results of inspections of manufacturers to address shortages;
- reduce or rebate user fees paid under GDUFA for foreign-approved drugs imported to address shortages; and
- share data on the reference product approved by FDA and the reference products to which foreign generic products were shown to be bioequivalent.