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With Limits Of OTC Drug Fact Label ‘Simple Boxes,' Complicated Conditions Remain Rx-Only In US

 
• By Malcolm Spicer

Merck & Co.'s three lovastatin switch attempts showed "it would be essentially impossible to present what they needed just within the confines of those simple boxes,” says Pegasus Research CEO Clark Richardson. Two decades after DFL launched, FDA, labeling experts and other industry stakeholders recognize its limits and have more consumer comprehension study data to guide decisions on what to include as well how to format an OTC label.

Merck & Co.'s modifications to the DFL for its proposed OTC switch of Mevacor in 2007 didn't convince FDA to approve what would have been the first nonprescription drug indicated for a chronic condition. • Source: Pegasus Research/FDA webinar

The futility of using OTC Drug Facts labels for products indicated to treat conditions more complicated than a cold or heartburn, headaches or allergies was apparent less than 10 years after the format was launched.

That was when Merck & Co., Inc. in 2007 made its third and final unsuccessful attempt to switch a...

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More from Regulation

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
• By David Ridley

If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos

AESGP Annual Meeting: Wastewater Directive Impact Assessment ‘Fundamentally Flawed’

 
• By David Ridley

AESGP president Jonathan Workman opens the 61st Annual Meeting with calls for industry unity in the face of the problematic revised EU Urban Wastewater Treatment Directive.

More from Policy & Regulation

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

House Appropriators’ $3.2Bn For FDA In FY 2026 Includes More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”