PDUFA bill will not contain a "track-and-trace" measure

For years, the FDA, Congress, drug companies, and retail distributors have struggled to agree on a nationwide system to ensure that counterfeit drugs (like fake Avastin) don't enter the U.S. drug supply chain. In a nutshell, industry stakeholders and regulators want to guarantee the safe, uninterrupted delivery of drugs from manufacturers all the way down to local retailers. Such a system, generally called "track and trace," would substantially reduce the chances of consumers encountering dangerous or substandard fake drugs.

When Congress took up debate over the Prescription Drug User Fee Act (PDUFA) this year, legislators seemed to broadly agree that the U.S. needed a track and trace system, but the House and Senate differed on exactly how that system should operate. Unfortunately, Pharmalot reports today that conference committee negotiators reconciling the House and Senate user-fee agreements have failed to reach an agreement on track and trace language:

The failure reflects a long-standing lack of agreement among the many players - drugmakers, wholesalers and pharmacies - about a suitable approach. A key sticking point is cost. To implement a uniform system that would allow each player to follow each shipment in the supply chain requires an investment to purchase equipment. This would include scanners for warehouses, trucks, and pharmacies to read bar codes placed on every bottle in each lot that is shipped.

Despite Congress's failure to procure an agreement on establishing a national system to protect the integrity of the drug delivery supply chain during PDUFA negotiations, it should keep trying. Without a commonsense national system to ensure the safe delivery of drugs, stakeholders will have to cope with complex and inconsistent regulatory schemes established by many different states. If the rules regulating drug delivery vary from state to state, manufacturers and distributors will incur needless compliance costs, costs that will be passed on to consumers through increased drug prices.

While the issue seems to be stalled for the moment, Congress could still pass a standalone bill establishing track and trace later. For an in depth look at the issues involved, and where things might go from here, see the RxTrace blog.

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