FDA, industry differ on level of track and trace needed in U.S.
Drug manufacturers may have derailed the FDA's plan to force creation of a vial-specific tracking plan to combat counterfeit drugs.
The plan is facing resistance from companies like Pfizer ($PFE) and Merck ($MRK), as well as from pharmacies and distributors. It is estimated it would cost pharmacies $6 billion to put their piece in place.
The industry is backing a plan that tracks lots instead of individual containers. They say it could be refined later to track smaller quantities. The plan put up by an industry coalition would put unique serial numbers on individual drug packages, but require scanning drugs only in "lots" when they get to distributors.
"Often in crafting policy, there's the search for the perfect and we just walk by the good," Pfizer spokesman Peter O'Toole told Reuters. "We could be saying in 10 years, 'we have to work on something perfect.' And in the intervening years, we would have done nothing, and that would be a shame for patients."
"To learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable," FDA Commissioner Margaret Hamburg recently wrote on the agency's blog. "We ... need authority to require a robust system to track and trace all drugs throughout the supply chain."
The discussion of how to trace individual containers has been going on for a long time, but no one wants to foot the bills. The experience of California is an indication of how difficult it has been to get the industry's support. It passed a track and trace law in 2004, but opponents have repeatedly delayed implementation. It is now set to go online in 2015.
The FDA and the industry are both seeking to have the outlines of a plan included in FDA user fee legislation now before Congress, but which plan, if any, makes it in is still up in the air.
- here's the Reuters story