FDA Holds Track & Trace Workshop

Confusion, anxiety reign as Agency talks tagging

By Stephen Barlas

Drug company executives displayed both confusion and anxiety over emerging federal drug tagging efforts discussed at a workshop hosted by the Food and Drug Administration in Washington on February 15. The meeting — Determination of System Attributes for the Tracking and Tracing of Prescription Drugs — was held to give the FDA input on standards it is required to develop on drug package authentication, interoperability, verification and data management. The requirement was contained in the Food and Drug Administration Amendment Acts of 2007.

That law includes no deadline for publication of final FDA standards, but the FDA is being pressured by a 2015 California deadline that manufacturers provide an item level e-pedigree for half their drugs going into the state. Ginny Herold, the executive officer of the California Board of Pharmacy, appeared at the FDA workshop via video. She said California law would be pre-empted if Congress passes a federal trace and trace requirement. “We need a federal solution,” she said. “But I am not sure when that will happen.”

There have been bills introduced in Congress that would give the FDA authority to not just establish standards, but force pharmaceutical companies to track and trace their products. But those bills have not moved in past sessions, and there is no indication that they will move in 2011 or 2012.

There was confusion based on Ms. Herold’s comments that the California “e-Pedigree” and “track and trace” are equivalent terms. Connie Jung, senior policy advisory in the FDA office of pharmacy affairs, later noted, “They are not the same thing.”

A McKesson executive complained that while the FDA was focusing on track and trace standards, California only required tracing. He asked, “Why are you ratcheting up the requirement?”

Ilisa Bernstein, acting deputy director of the office of compliance at the Center for Drug Evaluation and Research (CDER), answered that the agency is only publishing standards, not requiring tracing or tracking, at least not yet. She added that when the agency started working on track and trace in 2003, it expected — based on input from industry — to have a national system up and running by 2007. She added, ruefully, “It has been painfully slow and we hope to kick it up a gear or two.”

Asked whether the FDA could mandate track and trace — as opposed to publishing standards — in the absence of a congressional grant of authority, she declined to respond.

Stephen Barlas is a contributing writer for Contract Pharma. He can be reached at sbarlas@verizon.net.