There's even more political disagreement over legislation to better secure the nation's drug supply chain by establishing
a system to track pharmaceuticals from production to patient. Several senators sought to have a track-and-trace bill included
in the FDA Safety and Innovation Act (FDASIA) last year, but agreed to pull it to avoid delay on the broader FDA measure.
A comprehensive tracking policy in California that goes into effect in 2015, however, is spurring efforts to establish a national
drug-tracking system that would supersede diverse state requirements—a key goal for manufacturers that benefit from a uniform
national distribution process for medical products.
Bills crafted by House and Senate leaders generally agree on lot-level tracking, plus national standards and licensing for
wholesale distributors. Both bills pre-empt state pedigree laws, with the Senate measure giving states more leeway to enact
more stringent requirements.
The main point of dispute is the approach to product serialization and tracking. FDA seeks tracking to the drug unit level,
with an interoperable electronic data system able to support efficient recalls and quick identification of illegal and substandard
products. While most manufacturers now accept that approach, they side with distributors and pharmacists that want to start
with lot-level product serialization and tracking as a more affordable and practical first step. The Senate proposal sets
a 10-year schedule for establishing a unit-level tracing system, phasing in lot-level serialization over seven years, followed
by adoption of product verification at the unit level. The current House bill has no provision for a future shift to unit-level
tracking, a shortcoming that was roundly criticized by Democrats at an April E&C Committee hearing. At a minimum, FDA and
Democrats want to delay state pre-emption until some kind of national tracking system is fully operational.
Pharmaceutical manufacturers such as Johnson & Johnson are moving to comply with the California law by applying standardized,
serialized two-dimensional bar codes to packages and establishing processes to exchange serialized data with distributors
and pharmacies, explained J&J Vice-President Michael Rose at the House hearing. However, these efforts would be wasted, Rose
noted, if other states adopt different standards. "What we need is a clear end-game," said Rose, "where the goal posts are
E&C Chairman Fred Upton (R-Mich) initiated efforts to "mark up" the Republican-backed bill with an eye to approving legislation
by August 2013. Without some provision for unit-level serialization in the not-to-distant future, though, Congress probably
will reject drug-tracking legislation in 2013.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, firstname.lastname@example.org
. Read Jill's blogs at http://PharmTech.com/wechsler.