FDA plan RFIDs in drugs

I learn from Alan Cox, through FIPR that Scott Gottlieb, MD,Deputy Commissioner for Medical and Scientific Affairs at the US Food and Drug Administration (FDA) agency, in a speech last week on "Ensuring the Safety of America's Drug Supply" spoke about the agency's plans to force the drugs industry to embed electronic tags in pill bottles or even individual pills. Extract from the speech:

"With these more sophisticated drug counterfeit operations, FDA and all law enforcement activities that are partnering with us need to be even more effective in meeting these new challenges.

One of our proposed remedies at FDA is to strengthen our system for tracking drugs from the assembly line and right to the patient's bedside, by replacing the paperwork that now certifies the integrity of a pill with an electronic track and trace system that cannot be easily forged or forgotten.

This can be technology as miniscule microchips or "taggants" that go inside pill bottles, or even inside the individual pills. There's been considerable progress made in developing and deploying these sorts of technological tools.

Right now, we have given manufacturers more time to deploy this kind of technology. We have also put a stay on a rule that would effectively require these kinds of measures, a paper pedigree rule, to give people more time to move from paper pedigrees which would not provide the same kinds of protections to electronic pedigrees, which would. New technology would allow for less costly compliance, and better controls. The rule is written broadly enough so that electronic track and trace could be used in place of paper pedigree. We plan to make a decision soon on this stay, which is in place until December 2006, and we could reach a decision before that."

Thanks also to Ian Brown for reminding me that the Enterprise Privacy Group has developed a Privacy Code of Conduct on RFID tags.