Congress Weighs Drug Anticounterfeiting Bill

The next step is for the House Committee on Energy and Commerce and perhaps other House committees to consider the bill, which has bipartisan support. If the committee passes it, H.R. 4829 would go to the floor of the House. The prospects for passage are unclear, and it's not yet known whether any senators plan to introduce the bill in the Senate.

It's also unclear whether the pharmaceutical industry will try to fight the bill. If enacted, H.R. 4829 could raise costs for the industry by requiring the tagging of all prescription drugs. On the other hand, if the FDA were to set a national standard for creating pedigrees, that would be better for drug companies than having to comply with 50 different laws.

Gutknecht believes the introduction of the bill might put pressure on the FDA to require RFID-tagging of goods to facilitate the creation of electronic pedigrees—secure documents detailing the chain of custody as drugs move through the supply chain.

The FDA published a report in February 2004 encouraging the use of RFID to reduce counterfeiting (see FDA Endorses RFID Technology), and also held recent hearings on the pharmaceutical industry's progress toward adoption. At the meeting, acting FDA Commissioner Andrew C. von Eschenbach asked the agency's Counterfeit Drug Task Force to file a new report to the FDA by May 2006, containing recommendations on how the FDA should move forward to make the pharmaceutical supply chain more secure (see FDA to Update Its RFID Vision).

"Congressman Burton and I have said from the very beginning that we want to make sure that the drugs Americans take are safe, effective and affordable," says Gutknecht. "[Enacting this bill] would be a giant step in the right direction. The technology is available today, and it is affordable. The FDA needs to step up and take the lead. That's the bottom line."