FDA track-and-trace guidance document imminent?

Joshua Sharfstein, deputy commissioner of the US Food and Drug Administration, says the agency is planning to release its guidance on track-and-trace measures for medicines "very shortly."

Sharfstein told a House Energy and Commerce health subcommittee meeting yesterday that the guidance will establish "a standard for unique identification for prescription drug packages, which ultimately will help in identifying the whereabouts and authenticity of drug packages and distinguish them from counterfeits."

The subcommittee meeting - entitled Drug Safety: an update from the FDA - was convened as a first stage towards the drafting of a bipartisan bill on drug safety to safeguard the USA's medicine supply which is "increasingly sourced from abroad," according to committee chair Rep. Henry Waxman.

"We cannot forget the lessons of the 2007 heparin contamination catastrophe which resulted in numerous severe allergic reactions and the deaths of at least 80 Americans," he told the meeting.

In 1998, a US General Accounting Office (GAO) study found that roughly 80 per cent of all active pharmaceutical ingredients (APIs) used by US drug manufacturers came from overseas.

Sharfstein said the agency has made great strides in boosting its oversight of overseas trade - including the opening of offices in other countries and information-sharing agreements with foreign regulatory agencies.

But he said the FDA needs additional oversight tools to "access regulatory information quickly, hold all parties responsible for the quality of products in the supply chain, and have reasonable and reliable options for enforcement."