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# Sens. Hatch, Bennet Bill on Updating Drug Labels
- URL: https://www.fdaweb.com/sens-hatch-bennet-bill-on-updating-drug-labels/
- Published: 2018-09-28T12:00:00.000Z
- Updated: 2026-09-15T00:34:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142474

Senators **Orrin Hatch** (R-UT) and **Michael Bennet** (D-CO) have introduced *Making Objective Drug Evidence Revisions for New* (*MODERN*) *Labeling Act* (S 3519) that would authorize FDA to modify outdated drug labels to reflect new evidence relevant to a drug and its use. “When a drug receives marketing approval by the FDA, the drug’s label represents the most authoritative source of drug-related information available to prescribers,” according to a [release](https://www.hatch.senate.gov/public/index.cfm/2018/9/hatch-bennet-introduce-bill-to-update-outdated-prescription-drug-labels?ref=fdaweb.com) from Hatch and Bennet. “However, the label may fall ‘out-of-date’ as new information emerges from subsequent clinical trials or in the post-market setting. Drug sponsors are required to update a label when it becomes inaccurate, false, or misleading, but new scientific information regarding the ‘effectiveness’ portion of a label, including information related to dosage and new uses, often are not incorporated.”  
  
The lawmakers note that older drugs with expired patents are most likely to have outdated labels because the sponsors of these drugs, having lost market share to generic competitors, have few, if any, incentives to undertake the costly and time-consuming process of updating product labels. “In many cases, the sponsor of an off-patent product may withdraw its drug from the market, which causes generic versions of that drug to rely on a label that cannot be readily updated,” they say. “This is because under current law, a generic drug is required to have the same label as its reference. Therefore, when a reference product is pulled from the market the generic is unable to update its label.”