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What's a BTOD REMS?

For starters, it’s the acronym for Buprenorphine-containing Transmucosal Products for Opioid Dependence (BTOD) Risk Evaluation and Mitigation Strategy (REMS). The official Web site, btodrems.com, betrays its commercial origins, but exploring the site you will not find the name of a responsible corporation. A quick search, however, and I discovered the owner of the domain: Pharmaceutical Product Development, Inc. (PPDI), a company that appears to serve the pharmaceutical industry.

A couple months ago someone claiming to be from BTOD REMS left me a voicemail message to call back for more information but also directing me to the btodrems.com. When I asked the representatives at the other end of the line for whom they work I just got a run around. Eventually, but only when asked directly, one of them admitted that PPDI provides their paychecks.

According to an FDA representative the agency can require manufacturers to compile a document of strategies to mitigate risks associated with any prescription drug. Only when I inquired directly about PPDI did the representative acknowledge that company’s involvement in this particular REMS.

When I inquired at PPDI, that company’s representative seemed receptive to my suggestion to, in the interest of transparency, make PPDI’s role more apparent in related documents. She also acknowledged that this collaboration among several corporate entities might raise questions of anti-competitive activity and assured me that an antitrust consultant regularly scrutinizes these activities from that perspective.

Determining the source and implications of actual content of the REMS for BTOD may prove more problematic and may be the subject of future post.



 

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