1. Pink Sheet

PhRMA Sues To Block HHS Drug Importation Rule Citing Security, Safety, First Amendment Concerns

 
• By Brenda Sandburg

Complaint lists host of problems with implementation of the rule that allows states to sponsor programs to import certain prescription drugs from Canada; at least six states have enacted legislation to sponsor these programs.

Pill with Canadian flag wrapped around it and red ball inside
PhRMA seeks to halt rule allowing importation of Rx drugs from Canada • Source: Shutterstock

The Pharmaceutical Research and Manufacturers of America has asked a court to declare invalid the US Department of Health and Human Services’ final rule permitting importation of certain lower-priced prescription drugs from Canada, arguing that it will weaken the drug distribution system, undermine regulatory protections that keep consumers safe, and violate the Constitution.

The complaint, filed 23 November in the US District Court for the District of Columbia, was brought by PhRMA, Partnership for Safe Medicines, and The Council for Affordable Health Coverage against HHS, the US Food and Drug Administration, HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn

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Managed Access Agreement Fails To Help BioMarin’s Brineura Secure Routine Reimbursement In England

 
• By Francesca Bruce

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Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

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