Another counterfeit drug, this time the ADHD drug Adderall, has surfaced in the U.S. even as details of how the FDA and the industry should track drugs to protect against fakes is about to be hashed out by Congress.
The FDA this week warned that fake versions of the drug have shown up on Internet sites as shortages have made it difficult to get. Made by Teva Pharmaceutical Industries ($TEVA) and other generics companies, the short-acting form of Adderall has been in short supply since last year because of "active pharmaceutical ingredient supply issues," The Wall Street Journal reports.
There are concerns about counterfeits sold over the Internet making their way into the legitimate supply chain, and the industry and the FDA are looking at ways to better police the problem. The urgency was raised earlier this year when counterfeit versions of Roche's ($RHHBY) cancer drug Avastin were sold to more than four dozen physician practices throughout the U.S.
The House and Senate versions of the FDA reauthorization bill include language that would set up more stringent tracking of drugs to help prevent counterfeiting, but the details have yet to be set, Reuters reports. The FDA wants a nationwide program that includes and tracks identifiers on individual containers. 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. They have argued that to expect individual tracking from truck to warehouse to distributor to pharmacies is unworkable, at least for now.
FDA Commissioner Margaret Hamburg has made her case to consumers on the FDA blog, writing, "To learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable. We ... need authority to require a robust system to track and trace all drugs throughout the supply chain."
The U.S. is not the only country thinking this way. Europe starts requiring unique identifiers on all drug packages beginning in 2016. The Senate and House reconciliation process will sort out whether the FDA or the industry has the most clout on this issue, but the appearance of more fakes as the debate goes on may makes it harder for Congress to limit the agency's authority to do what it thinks is best.