Opioid analgesics Classes

FDA Approves Class-Wide Opioid REMS After More Than Three Years

September 6, 2013 – 11:04

Big Sky Fire Department

By Alexander J. Varond –

After more than three years, FDA approved a class-wide Risk Evaluation and Mitigation Strategy (“REMS”) for extended-release and long-acting (“ER/LA”) opioid analgesics on July 9, 2012. The ER/LA opioid REMS applies to more than 20 companies and 30 products, and while it includes a shared implementation program, each opioid product REMS is to be written and approved as an individual document.

In this post, we first briefly discuss the history of the program’s development and then explain the implications of the new class-wide REMS.

A long road for a rather dull REMS. On February 6, 2009, FDA sent letters of ER/LA opioid analgesics detailing the need for a new REMS. During a media briefing on February 9, 2009, FDA officials expressed the agency’s ambitious plan to develop a class-wide opioids REMS and further expressed that the program was “going to be the largest risk management effort [FDA had ever] undertaken.” Rightly so, FDA announced it was taking on an effort aimed at addressing the nation’s growing prescription drug abuse epidemic. During the media briefing, FDA also intimated that it was actively exploring requiring mandatory training for prescribers and developing a more restrictive distribution system.

In February 2009, FDA felt it had a “pretty good outline” of what the REMS should include but took steps to consult with stakeholders, health professionals, and patient advocacy groups about the new REMS. After collecting information from these groups, FDA planned to write letters to manufacturers and explain the requirements for the new REMS. Within six months of the letters’ issuance, FDA expected companies to implement the REMS.

More than two years later, in April 2011, FDA finally sent letters to manufacturers of ER/LA opioids detailing its requirements for a new REMS program. We discussed those requirements here.

Now, more than three years after beginning the opioid REM process, the final REMS is completed and amounts to essentially a mere education and monitoring program. Additionally, despite FDA’s statement in 2009 that “voluntary programs have not been successful in getting us where we need to go with maintaining access to legitimate patients and dramatically decreasing the serious adverse event reports, ” the healthcare professional education provided by the REMS is in fact voluntary.

It is clear that, in 2009, the agency underestimated both (1) the complexity of creating a program that did not adversely affect patients in need of pain management and (2) the difficulty associated in creating a class-wide REMS program with many manufacturers. FDA also miscalculated its authority to create a mandatory training program (FDA later considered its ability to create a mandatory training system but decided that it would need a grant of legislative power to create such a system).

Source: www.fdalawblog.net


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