U.S. Senate Bill Proposes Technology to Authenticate Drugs

Some experts, however, say the amendment may be confusing, and could be interpreted to read that pharmaceuticals sold on the Internet must—at a bare minimum—have counterfeit-resistant technologies that can be detected visually, without the use of interrogators, scanners or other devices.

Some might surmise that even though RFID can be used, they'd still need to support technology that is visible to the naked eye, says Doug Farry, managing director and chair of the RFID practice at McKenna Long & Aldridge, a nationwide law firm focused on public policy and technology. Farry also oversees McKenna Long's RFID Law Blog.

Also of concern to Farry is that the Senate passed the bill reauthorizing the PDUFA with little, if any, discussion regarding Enzi's amendment. Apparently, no input was solicited from leaders within the RFID industry who could have proposed that the technology be mentioned in the amendment. "No one in the industry," he says, "noticed or had any apparent strategy to push solutions that supported RFID."

The FDA has been advocating the use of RFID by pharmaceutical companies to track drugs within the supply chain in order to fight drug counterfeiting and create electronic pedigrees, or e-pedigrees (see FDA Issues New 'Counterfeit Drug Task Force' Report). E-pedigrees record where a drug is manufactured and how it is distributed.

Still, Farry says, the amendment's failure to mention RFID doesn't surprise him. The PDUFA is considered must-pass legislation, he says, "so everyone is trying to load up as much as they can in this legislation." In addition, lobbyists who support microdots, holograms and other identifiers difficult to forge have been promoting the use of those technologies for years. "This is not the first time," notes Farry, "that this kind of language [seen in the Enzi amendment] has floated around for different types of applications."

Surprising or not, if similar language appears in the U.S. House of Representative's version of the PDUFA and the Safe Internet Pharmacy Act of 2007, it's likely to have ramifications. For example, drug manufacturers, wholesalers and others that might have adopted RFID may opt to wait until the Secretary of Health and Human Services recommends authentication technologies.