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Political Winds, Like Previous Storms Over US FDA Decisions, Stir Around OTC Contraceptive Proposal

 
• By Malcolm Spicer

Experts spoke with HBW Insight about potential impact on US contraceptive market from Supreme Court’s decision in Dobbs v. Jackson overturning its 1973 ruling in Roe v. Wade, which was upheld in 1992 ruling in Planned Parenthood v. Casey, stating a woman has a constitutional right to reproductive health services.

• Source: Shutterstock

More than 60 years after daily oral contraceptives were made available Rx in the US, extending sales for the first time to OTC is proposed against a backdrop of political and judicial pressures potentially imposing restrictions on access to all birth control drugs.

“I think that in the wake of Dobbs, there's certainly a sense of panic across truly many different sectors in...

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FDA Takes World Tour In Recent OTC Warnings

 
• By Malcolm Spicer

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

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

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