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‘Storm Of Change’ Could Propel Industry On Making Daily Oral Contraceptive Available OTC In US

 
• By Malcolm Spicer

“It’s going to be industry people like me that have to make a decision that we're going to spend the time, we're going to spend the money to work with FDA for the many years it takes generally speaking to get these things approved,” says Femasys CEO Kathy Lee-Sepsick.

• Source: Shutterstock

The chief executive of a woman’s reproductive health technology developer suggests pharma and medtech firms ask why an oral daily contraceptive isn’t already available OTC in the US, and answer by taking responsibility to make it happen.

“We all could probably agree that women understand how to use their birth control pills, they've had access to them...

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Green Regulation Is ‘A Baseline Not A Burden’ – Behind Opella’s B Corp Journey

 
• By David Ridley

“For us, regulation is the floor, not the ceiling,” Opella's chief sustainability officer Marissa Saretsky tells HBW Insight as the firm gains B Corp Certification. Other topics covered in this exclusive interview include Opella's position on the revised Urban Wastewater Treatment Directive.

US FDA: No Replacement Yet For Animal Methods In Testing Systemic Effects Of Sunscreens

 
• By Lauren Nardella

While FDA fully supports the recent roadmap to reduce and eliminate animal testing, animal tests are still necessary for assessing systemic effects, says Jacqueline Corrigan-Curay, acting director for CDER, during a House Energy and Commerce Health Subcommittee hearing.

Pharma Deutschland Seeks To Enter Urban Wastewater Legal Dispute

 
• By David Ridley

The Urban Wastewater Treatment Directive “in its current form, is at an end,” insists Pharma Deutschland CEO Jörg Wieczorek. To put the directive to bed once and for all, the association has applied for leave to intervene in the ongoing EU legal battle in its own right.

Cloudy Tariff Conditions Expected To Linger In US

 
• By Malcolm Spicer

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

More from Policy & Regulation

US FDA: No Replacement Yet For Animal Methods In Testing Systemic Effects Of Sunscreens

 
• By Lauren Nardella

While FDA fully supports the recent roadmap to reduce and eliminate animal testing, animal tests are still necessary for assessing systemic effects, says Jacqueline Corrigan-Curay, acting director for CDER, during a House Energy and Commerce Health Subcommittee hearing.

House Health Subcommittee Members Agree OMUFA Crucial, Split On FDA Staff Cuts’ Impact

 
• By Malcolm Spicer

Subcommittee members aren’t on same page about whether FDA staff cuts ordered by the Trump administration will prevent the agency from fulfilling its responsibilities for the OTC drug sector.

House OMUFA Reauthorization Bill Takes On Clarifying Standards For Tests To Meet GRASE

 
• By Malcolm Spicer

Health Subcommittee will discuss reauthorizing OMUFA during a hearing on how to “maintain and improve” the public health workforce and rural health as well as access to OTC medicines.