Federal Legislation requires Internet pharmacies to tag drugs
The legislation would amend Chapter V of the Federal Food, Drug, and Cosmetic Act. Among the requirements listed in the bill for those Internet pharmacies seeking a license to sell drugs to persons in the United States is this:
"The Internet pharmacy agrees to affix to each shipping container of drugs to be shipped in the United States such markings as the Secretary (of Health and Human Services) determines to be necessary to identify that the shipment is from a licensed Internet pharmacy, which may include anticounterfeiting or track-and-trace technologies."
Congress does plan to get involved in the question of whether and how RFID will be used in the pharmaceutical space. This is only the beginning of what I expect to be a busy legislative year on these questions. This legislation may get linked in the legislative process to the larger reauthorization of the Prescription Drug User Fee Act, which is considered "must-pass" legislation because it authorizes the collection of the fees that pay for the operations at the FDA.
This sounds like political pandering that will create a false sense of security. I truly do not understand
Additional comments on my blog:
http://drugchannels.blogspot.com/2007/02/importing-chinese-counterfeits.html
And as I point out in this month's Pharmaceutical Manufacturing magazine, importation probably won't save very much money anyway.
http://www.pharmamanufacturing.com/articles/2007/037.html
Adam
The FDA has little enforcement ability within the US (most is done by the states).
One of the leading arguments made against allowing importation of drugs from Canada or abroad, to take advantage of price controls imposed by foreign governments, has been the risk of American consumers receiving counterfeit or "dangerous" drugs that have not been tested and approved by the FDA. This provision is clearly designed to counter that argument.
Whether RFID tags on imported pharmaceuticals can actually solve that problem is almost irrelevant.
The point of the post was that Congress is weighing in with legislation impacting the use of RFID on pharmaceuticals -- legislation that has an opportunity to be enacted because of the politics around drug importation. Right or wrong, effective or not, those in the pharmaceutical industry and/or the RFID space need to pay attention and engage with Congress to make sure they are making sound decisions.
Hello,
I'm not seeing the correlation between RFID tracking and the anti-counterfeit legislation. Why and how would they use the RFID tags to help solve this situation?
The Senator is likely aware that the FDA is supporting RFID as a tool to provide electronic pedigrees identifying where drugs have been throughout the supplychain from manufacturer to patient. The FDA is hoping that epedigrees will reduce incidents of counterfeiting by assigning responsibility throughout the supplychain for the authenticity of the drugs. Since the FDA will not be able to enforce any laws or regulations on pharmacies outside the jurisdiction of the US, the Senator's bill is intended to ensure that any foreign pharmacy making sales in the US must, as a condition of licensing, comply with any electronic pedigree or RFID requirements under US law or regulation.
Again, the bigger issue is that -- as the legislation progresses -- there is an opportunity for a clarification in law that would direct the FDA how to put epedigrees in place. That is both an opportunity and a risk for companies in the RFID space, or the pharmaceutical supply chain business (manufacturers, distributors, retailers, wholesalers, etc) depending on what Congress ultimately decides to do.