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


FDA's Unlikely Defenders

This article was originally published in RPM Report

Executive Summary

The primacy of FDA-approved labeling has an unlikely advocate. The Washington Legal Foundation is joining the EPO coverage dispute to tell CMS not to step into FDA’s turf.

You may also be interested in...

Straight Talk About Cancer Drug Coverage

CMS’ coverage of cancer drugs isn’t as automatic as you think. Here’s how the Medicare agency sees it.

CMS Takes A Back Seat to No One When it Comes to Drug Safety

Amgen, J&J and a host of supporters urged CMS to wait until FDA completes its safety review of EPO before acting to limit coverage. CMS is having none of it.

Taking on CMS

Amgen and J&J have billions of dollars at stake in the battle to convince CMS to change its coverage proposal for EPO in cancer patients. Win or lose, their efforts will be a valuable case study for any other manufacturer that fi nds itself facing an adverse reimbursement policy.

Related Content


Related Companies




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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