Global Drug Supply - Strategize Traceability Now!

I have to admit that I put on my California 'blinders' every now and then. This is one case where I got surprised to see what is going on in the global setting of drug traceability. I read this superb IndustryWeek article that frames, yet again, the pain induced when there is a general lack of harmonization, Global Drug Traceability Mandates: Why Act Now? - Should pharmaceutical companies sit back and wait for someone else to blaze the drug traceability trail? Author Brian Daleiden taps into my Californa (CA) blindspot by stating, "California decided to go one step further and include an item-level drug serialization requirement in their state mandates. Given the significant incremental investment this would require, it was no surprise when the start date for CA compliance was pushed back to 2015, giving the industry a sigh of relief. But should it? A closer look at the current domestic landscape should give pause to anyone feeling too comfortable." In a nutshell, the article's conclusion challenges us to think about whether companies are making the right decisions, "The myriad of business and regulatory issues confronting most companies along the global pharmaceutical supply chain can be daunting. Against such uncertainty, it is understandable that the temptation is to take the path of least resistance and isolate and tackle each issue as it comes. Unfortunately, it is becoming clearly apparent that the industry has reached a tipping point where this approach will no longer work. The operational costs and business risks are just too high." Global Drug Traceability Mandates: Why Act Now? - Should pharmaceutical companies sit back and wait for someone else to blaze the drug traceability trail? (displayed on one page) 

Related Posts: FDA Draft Guidance - Drug Supply Chain and SNIs FDA - Global Drug Supply Chain Needs Better Oversight CA Gov Delays e-Pedigree Mandate to 2015 CA E-Pedigree - Pedigree and Serialization FDA Draft Guidance On Good Importer Practices 

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FDA - Focus On Opioid Manufacturer REMS FDAAA

Updated September 15, 2016

The original post didn't age well (broken links).

You might also be interested in:
Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids (FDA.gov)

- -  original post follows below  - -

If you're involved in or follow opioid manufacturing, you'll want to follow the FDA's focus on manufacturers of certain opioid drug products. FDA indicates that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks. The affected opioid drugs include brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) when necessary to ensure that the benefits of a drug outweigh the risks. You can expect to hear more about this over the next several months from the FDA.

More FDA Information About This Topic:
Transcript for FDA's Media Briefing on the Safe Use of Opioids
February 9, 2009 [pdf 52 KF] Audio [5.09 MB MP3]
FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs

Previous Posts:
Opiates Can Kill Kids!

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