End game for US medicines traceability bill?

The US Senate looks poised to give its blessing to a House of Representatives bill that would introduce a track-and-trace system for medicines as well as new laws on compounding pharmacies.

The Drug Quality and Security Act (H.R. 3204) was passed by the House at the end of September and has just cleared a second reading in the Senate, which means it has officially been placed on the legislative calendar, the agenda for bills that have come through the committee process.

The House passed this bill in late September, by a voice vote, but progress in the Senate appears to be hampered by continued horse-trading over President Obama's healthcare reforms, which led to the recent US government shutdown.

Bloomberg reports that Republican Senator David Vitter of Louisiana is trying to tack an amendment onto H.R. 3204 that would abolish employer contributions for healthcare received by lawmakers and congressional aides under Obamacare.

It seems Vitter has been offered a vote on his amendment if he refrains from adding it to other bills, but has turned down the offer.

H.R. 3204 would introduce a federal, serialization-based track-and-trace system for medicines involving the use of standard numerical identifiers (SNIs) to individual packs and (non-mixed) cases within four years of the legislation being adopted, with electronic tracing of production through the supply chain mandated within 10 years.

It also aims to eliminate duplicative government regulations on drug manufacturers, wholesale distributors, pharmacies, re-packagers, and third-party logistic providers, and creates floor and ceiling licensure standards for wholesale distributors.

In addition to the track-and-trace elements the DQSA also shakes up the regulations on compounding pharmacies and aims to prevent reoccurrence public health crises like the meningitis outbreak tied to the New England Compounding Center (NECC), which killed 64 people last year.

Senate Majority Leader Harry Reid is said to be pushing to expedite H.R. 3204 and other outstanding bills before the Thanksgiving recess, to try to avoid the last-minute law-making rush that tends to occur in the build-up to Christmas.

Govtrack.us is currently putting the chances of the bill being enacted at 42 per cent. The Congressional Budget Office (CBO) estimates that H.R. 3204 will authorise the collection of $27m in user fees for fiscal years 2014-2018.