Despite delays California is still leading the US into ePedigree and the law will begin to take effect in 2015. Industry fears this could lead to different standards in each state but the US Food and Drug Administration (FDA), the group that could enforce a nationwide law, doubts it can intervene yet.
At yesterday’s PDUFA (Prescription Drug User Fee Act) hearing Deborah Autor, deputy commissioner for global regulatory operations and policy at the FDA, was asked by Congress if the Agency needs more authority to adopt track-and-trace. She answered “yes”.
The FDA could implement track-and-trace, Autor said, but it is unclear if the policy would be binding for industry or pre-empt state laws. If the FDA is unable to pre-empt state standards a “patchwork” of laws could emerge and complying with each would add to the regulatory burden on industry.
Companies voiced these worries after a FDA workshop last year. “In the absence of clarity regarding federal pre-emption, many companies…must begin funding their plans to develop line designs, system architecture and new business processes to meet requirements for California”, said AstraZeneca.
Adoption of a nationwide track-and-trace system could tighten security in the US but much of the focus at the hearing was on global supply chains and how to ensure the quality of products coming from overseas.
Margaret Hamburg, commissioner of the FDA, said the Agency will transition over the next decade from being a domestic organisation working in a globalised world to a truly transnational body.
Globalisation is one of the most important challenges facing the FDA, Hamburg said, and the Agency will need more resources and new models of working to tackle the problem. Cooperating with other regulators and GDUFA (Generic Drug User Fee Act) are early indicators of the FDA’s new approach.
PDUFA could also help the FDA. Some members of Congress want aspects of a proposed drug safety act to be incorporated into the new version of PDUFA to give the FDA more powers to oversee global biopharmaceutical manufacturing.