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Back in the U.S.A.

Drug reimportation legislation seems likely to pass in Congress. It may jumpstart track-and-trace packaging technology.

Pw 8529 Re Import Graphic

The U.S. Food and Drug Administration looks like it will get some help from Congress to encourage drug manufacturers to adopt track-and-trace and anti-counterfeiting technologies on drug packaging. Legislation likely to reach President Bush’s desk would open the door to commercial importation of brand-name prescription drugs from numerous developed countries—importation that is now illegal—as long as the packaging of those drugs meets certain track-and-trace and anti-counterfeiting technology standards.

A different version of the Pharmaceutical Market Access and Drug Safety Act (S. 242/H.R. 360) actually passed the Senate by a veto-proof margin of 68-32 in the summer of 2006 when it was attached to a Department of Homeland Security appropriations bill. That bill would have allowed imports only from Canada.

But Republican leadership in the House refused to accept the amendment, and it was jettisoned from the appropriations bill. This year the House version is being sponsored by Rep. Rahm Emanuel (D-IL), the number two Democrat in the House. Sens. Byron Dorgan (D-ND) and Olympia Snowe (R-ME) are carrying the ball in the Senate as they have for the past half-decade; that bill has support up and down the political spectrum, including from Sen. Trent Lott (R-MS), the number two Republican in the Senate.

Package-inspired qualifications

The Dorgan bill would require U.S. wholesalers and importers who want to either reimport prescription pharmaceuticals that were originally manufactured in the U.S. and exported to Canada and Europe, or drugs that were initially manufactured there, to insure that each package is armed with track-and-trace and anti-counterfeit technology.

The Dorgan bill gives the FDA—which would have responsibility for inspecting the imported packages—considerable latitude here. The FDA would have to insure that the wholesaler could prove the chain of custody back to the manufacturer. But exactly how that would be done has yet to be worked out.

The bill says that the methodology for insuring chain of custody "may" include standardized anti-counterfeiting "or" track-and-trace technologies that would "identify the discrete package of the drug." But the bill notes that those technologies must be economically and technically feasible.

The bill then goes on to mention additional packaging requirements. The first additional requirement is that each package would have to contain a standardized numerical identifier unique to each package, which appears to parallel the California 2009 requirement for drug package ePedigrees.

Anti-counterfeiting, too

Next, the package would also have to have overt, optically variable counterfeit-resistant technologies which meet certain standards: one being visible to the naked eye, but also incorporating additional layers of non-visible covert security features "up to and including forensic capability."

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