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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 drug regulation attorney Eva Temkin, a partner at King &...

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More from Rx-to-OTC Switch

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.

Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By David Ridley

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
• By David Ridley

At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

Over The Counter: Everything You Wanted To Know About Real World Evidence, With IQVIA’s Volker Spitzer

 
• By David Ridley

HBW Insight finds out all about real world evidence and its potential for the OTC industry by chatting with IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer.

More from Health

‘We Must Have The Truth’ – Calls For UWWTD Review Intensify As Evidence Looks ‘Shaky’

 
• By David Ridley

The evidence underpinning the “polluter pays” principle of the revised Urban Wastewater Treatment Directive - which calls on Europe's pharmaceutical industry to cough up at least 80% of the cost of updating wastewater treatment facilities - is looking increasingly shaky, according to a new report.

People On The Move: Appointments at Hermes, Assosalute, Moberg

 
• By Tom Gallen

A round up of the latest European consumer health exec moves: Hermes hires management board chair; Assosalute elects directors; Moberg appoints ex-Orkla Health CEO.

Loper Bright ‘Might Not Be Cataclysmic’ With FDA’s ‘Good Reputation’ For Science – Attorney

 
• By Malcolm Spicer

Bridget Dooling, law school professor who reviewed draft regulations from FDA and other agencies as OMB attorney, says history of federal court decisions in litigation challenging FDA’s interpretation of statutes points to judges typically defer to agency decisions based in science.