After much anticipation, FDA finally announced the release of its long-awaited public database of authorized wholesale distributors last week. Well, there really wasn’t any FDA announcement. I did get an email though, and FDA posted a link to the database on its Drugs page under News and Announcements (see October 6, 2015). FDA did, however, issue a news release the same day announcing the launching a national public education campaign to prevent and reduce tobacco use among multicultural youth. While this is a noble public health goal for FDA, I’m left wondering why the agency was apparently unwilling to publicly announce a key milestone under the Drug Supply Chain Security Act that has the potential to dramatically increase the health and safety of all vulnerable patients. Protecting our Nation’s pharmaceutical distribution supply chain from insidious prescription drug diversion and counterfeiting crimes is a noteworthy event, not one that should be relegated to email blasts and links buried within FDA’s web site, two-clicks away from its home page.
But my real concern is not with the lack of an FDA announcement, it has more to do with the content of this database. My strong belief is that many of our Nation’s most susceptible wholesale distributors, those secondary wholesales most often associated with prescription drug diversion schemes, have not yet reported. The question then becomes what is FDA going to do about it? This database loses its luster if it’s viewed as unreliable, incomplete, and something of an FDA afterthought.
To address this issue, FDA should promptly advise each State board of pharmacy or other appropriate regulatory authority to review their lists of currently licensed wholesale distributors to identify those which have not yet reported to FDA as of March 31, 2015, pursuant to FDA’s draft guidance on this requirement. FDA should then initiate appropriate enforcement actions ranging from warning letters to criminal prosecutions for each wholesale distributor which has not complied with this reporting requirement. Under the FD&C Act, any person who fails to comply with the wholesale distributor reporting requirement under section 503 (e)(2)(A) and is found to have violated section 301 (t), becomes subject to potential misdemeanor and felony penalties under section 303 (a).
It is crucially important for FDA to put corrupt secondary wholesale distributors on notice that the agency is committed to enforcing this new DSCSA reporting requirement and, more importantly, that strengthening our Nation’s pharmaceutical distribution supply chain is a top agency priority. Anything less will be interpreted as a signal amongst this group of wholesalers that FDA is continuing to do business as usual. This status quo approach must be avoided at all costs and is increasingly becoming a very dangerous proposition for patients everywhere.