Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Judge dismisses Plan B suit

This article was originally published in The Tan Sheet

Executive Summary

A judge in the U.S. District Court for the District of Columbia dismisses a case challenging FDA's OTC approval of Barr Pharmaceuticals' Plan B emergency contraceptive for consumers 18 years of age and older. Judge John Bates ruled March 4 the court "has no jurisdiction" in the case brought by several groups including the Association of American Physicians and Surgeons and Concerned Women for America, in part because they "failed to exhaust their administrative options" before bringing the case to court. The groups unsuccessfully argued that the OTC approval of Plan B put consumers at risk because they did not visit their health care providers, placed pharmacists at increased liability risk and unfairly increased physician competition, among other complaints...

You may also be interested in...



Ironwood Ends Phase III GERD Program, Will Cut 100 Jobs

The company has no development programs left in its R&D pipeline and will focus entirely on the commercialization of IBS drug Linzess while seeking late-stage assets from external sources.

FDA Finalizes Guidance On Blood Glucose Meters With Separate Documents For OTC, Rx Devices

The documents issued by the US agency on 29 September set slightly different accuracy standards, reflecting the increased fragility of hospital patients.

Hahn Praises CDRH Staff For Mitigating COVID-19 Deaths

The US FDA commissioner published a blog post commending and highlighting the work device center staff have done during the pandemic to speed tests and devices to market to save lives.

Topics

UsernamePublicRestriction

Register

LL1134044

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel