US House passes PDUFA reauthorization by 387-5; bill now heads for reconciliation with Senate version

With the same near-unanimity that the Senate demonstrated the week before, the House passed HR 5651, the Food and Drug Administration Reform Act, on May 30. The reconciled bills are expected to be before the President Obama before the end of June for signature. The main import of the bills is to reauthorize the Prescription Drug User Fee Act (PDUFA), which funds a major part of FDA drug reviews; with this reauthorization, PDUFA expands to medical devices, generic drugs and the biosimilars expected to start showing up soon. Other elements pertain to addressing drug shortage problems; FDA inspections of overseas manufacturing facilities, and expedited reviews for certain life-saving drugs.

Missing from the House version, however (and, after some last-minute parliamentary shuffling, included in the Senate version) is the RxTec Act—language proposed by a consortium of manufacturers, distributors and retailers to allow for serialization of drugs at the unit level, and tracking of them at the lot level when a suspected diversion or counterfeit intrusion has occurred. The final language of the Senate bill specifies that the serialization requirement will go into effect “not later than 4-1/2 years” after passage of the bill—which would seem to be January 2017. Other dates specified include 2018 for repackagers; 2019 for distributors, and 2020 for dispensers. On its face, this schedule would push the timeline for complying with California’s e-pedigree rules by two years—and while California included a clause in its legislation (when passed in 2008) saying that any federal rulemaking would pre-empt state rules, the Senate version includes its own clause specifying that its rulemaking “shall not trigger” the California pre-emption.

Moreover, the RxTec provisions are less strict than those of California, whose overall goal is to be able to track the movement of a drug unit from the point of manufacturer to the shelf of a pharmacy stockroom, on demand. If the Senate language remains in the final law, the picture for industry compliance will remain muddled until all this is sorted out.