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Court Ruling Compels Emergency Contraceptives Over The Counter

 
• By Dan Schiff

Under a federal judge’s order, FDA must reverse its denial of the Center for Reproductive Rights’ 12-year-old citizen petition and allow universal OTC access to Plan B One-Step and equivalent levonorgestrel-based emergency contraceptives within 30 days.

Plan B One-Step and equivalent emergency contraception products must be approved for universal OTC access by May 4, under a federal judge’s ruling against FDA and the Department of Health and Human Services.

Twelve years after being filed and more than a year after being denied, the Center for Reproductive Rights’ citizen petition...

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More from Legal & IP

Mifepristone: Judge Orders US FDA To Rethink Need For REMS Restrictions

 
• By Sue Sutter

A federal judge in Hawaii ruled the FDA failed to consider statutory factors relevant to the REMS and provide a “reasoned explanation” for its restrictive treatment of the drug, but remand could result in an agency determination that more extensive restrictions are needed.

EU Biotech Act: Careful Drafting Needed To Protect SMEs From ‘Over-Regulation’

 
• By Eliza Slawther

In this second of a two-part series, Clifford Chance partner and life sciences legal expert Gunnar Sachs explains how the upcoming EU Biotech Act could place extra strain on SMEs due to overlap with other regulations and how to mitigate this through careful planning.

How The EU Biotech Act Could ‘Level The Playing Field’ For SMEs

 
• By Eliza Slawther

While industry awaits specific details on the EU Biotech Act, Clifford Chance partner and life sciences legal expert Gunnar Sachs explains the key aims of the new legislation and discusses the potential benefits for biotech firms.

‘Sufficiently Large To Act As An Incentive’: Teva’s EU Provigil Antitrust Fine Upheld Again

 
• By Dean Rudge

The EU’s top court has rejected Teva and Cephalon’s final appeal, ruling that their 2005 settlement to delay a generic version of modafinil was inherently anticompetitive and upheld a €60.5m fine.

More from Pink Sheet

NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job

 
• By Sue Sutter

The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.