FDA’s Gottlieb Blasts Importation and Calls for New Technology

Scott Gottlieb, FDA’s deputy commissioner for medical and scientific affairs, took aim at drug importation schemes in a speech this week, calling them utterly inconsistent with many of FDA’s fundamental practices. He called for better use of technology to secure the supply chain, saying RFID (radio frequency identification) was the leading contender, but not the only one.

“Paper money has more than 20 embedded technologies, both overt and covert and some that are only known to the Treasury Department that handles the money. We need multiple layers like that to build more safety and security in prescription drugs as well, and we're going to be working to bring forward proven technologies, and to develop the proof for these other technologies,” said Gottlieb, speaking Tuesday in Washington, DC, at an event on counterfeit drugs, sponsored by the Pacific Research Institute.

The flow of counterfeit drugs around the world and into the United States has steadily grown. Perhaps half or more of the prescription drugs taken are not legitimate products, said Gottlieb.

Studies by the World Health Organization have suggested that developed markets –particularly Europe – where parallel trade has created porous borders and permeable controls that leave many opportunities for counterfeit drugs to enter supply chain. Drugs taken to treat chronic conditions, such as high blood pressure or high cholesterol, seem to be among the preferred targets of the counterfeiters.

FDA opened six counterfeit drug cases in 2000, then 30 in 2003, and 58 in 2004. Late last August, the agency broke up a Lipitor counterfeiting and smuggling operation that was trafficking almost $50 million worth of the drug.

“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,” said Gottlieb.

“This can be technology such 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, by putting a stay on a rule that would do just that,” said Gottlieb.

Gottlieb said FDA planned to make a decision on this stay soon, perhaps before its scheduled end in December 2006.

RFID and a new bar code labeling application look promising. New color-based technologies packaging that embed multiple different layers of protection are also being evaluated. 

“Many people believe that FDA interprets our counterfeit drug report that we issued to address this growing threat as saying that we want RFID implemented by 2007. We said that an electronic pedigree should be implemented by 2007, and right now, RFID is the most promising technology to deliver on that need.,” said Gottlieb.

He lambasted importation schemes, saying no amount of “well-intentioned legislation, to apply a safe way to check the drugs coming in through these different importation schemes” is going to fully guarantee their safety.



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