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# PMI ‘Major Change’ in Drug Labeling: Attorneys
- URL: https://www.fdaweb.com/pmi-major-change-in-drug-labeling-attorneys/
- Published: 2023-06-07T12:00:00.000Z
- Updated: 2026-09-14T18:37:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154639

Five Hogan Lovells attorneys say that if the FDA proposed Patient Medication Information (PMI) is finalized, it would represent “a major change in Rx drug labeling.” Writing in an online [post](https://www.jdsupra.com/legalnews/fda-proposes-mandatory-patient-labeling-5274718/?ref=fdaweb.com), the attorneys say that manufacturers have struggled to translate approved instructions for healthcare providers into patient-friendly language for patient brochures, direct-to-consumer ads, and direct-to-patient communications. “If finalized,” they say, “a [PMI](https://www.fdaweb.com/fda-proposes-1-page-patient-medication-information/) could facilitate those efforts and speed the use of industry-to-patient advertising and promotion.”

The analysis notes that FDA efforts to promote patient labeling have failed in the past due to opposition from retail pharmacies and larger forces opposed to regulation generally.

“It remains to be seen whether this effort will overcome these hurdles or lead to more confusion around patients’ use and understanding of drug labeling,” the attorneys write. “Other hurdles, such as the evidence required to support information in the PMI or how closely follow-on generics or biosimilars must match a reference product’s PMI will also need to be closely monitored.”

The post says the proposed rule also raises questions about its potential impact on the existing product liability landscape for manufacturers of FDA-approved drugs and biologics. One key question, it says, is the interplay of the proposed rule with the learned intermediary doctrine.

The agency will receive comments on the proposal until 11/27.