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Bullseye On OTC Reproductive Drug Approvals In US After Federal Judge Questions FDA Expertise?

 
• By Malcolm Spicer

Attorneys comment to HBW about likelihoods of litigation to challenge FDA’s approval of OTC emergency contraceptive and of influence growing to affect agency’s consideration of NDA for OTC daily oral contraceptive.

• Source: Shutterstock

A federal court ruling to stay the US Food and Drug Administration’s approval of abortion drug mifepristone likely will spur challenges to product approvals in categories across the agency’s oversight, with OTC emergency contraceptives potentially first on the list.

“I think if permitted to stand, the district court’s ruling could be destabilizing for drug development broadly,” said food and...

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More from Rx-to-OTC Switch

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

Over The Counter: Driving Innovation In France’s Self-Care Market, With NèreS’ Luc Besançon

 
• By David Ridley

HBW Insight speaks to NèreS' executive director Luc Besançon about the key issues facing France's self-care industry, especially Rx-to-OTC switch and the revised Urban Wastewater Treatment Directive.

Allergy Ingredient Itch Warning, ACNU Final Rule Scratch Extent Of FDA Authority For Label Changes

 
• By Malcolm Spicer

Effective date for ACNU OTC switch final rule and finding of severe itching from long-term use of common allergy ingredients are bookends for limits of FDA’s authority for product label changes.

More from Health

Senators’ Questions Stray Far From OMUFA During HELP Committee Hearing On Reauthorization

 
• By Malcolm Spicer

HELP members state frustration with layoffs at FDA and pose questions about topics from generic drug approvals to OTC switches, and from manufacturing location labeling to whether the federal agencies intrude on US consumers. Still, acting CDER director Jacqueline Corrigan-Curay makes clear the resu

People On The Move: Appointments At Klosterfrau, Haleon, Opella

 
• By Tom Gallen

A round-up of the latest consumer health industry appointments: Kloserfrau makes changes to management in Germany; Haleon hires Pakistan head; Opella names Americas leader.

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