US legislators in the House of Representatives passed a major piece of legislation on Monday afternoon, passing by a voice vote a measure meant to secure the pharmaceutical supply chain from counterfeit products.
Track and Trace
The first bill is known as the Safeguarding America's Pharmaceuticals Act (SAPA), and institutes a system more commonly known as "track and trace," so-called because it allows authorities to track where a product is going and trace where it has been.
The current iteration of the law has been in the works since at least 2012, when its proponents attempted to get it passed through the FDA Safety and Innovation Act (FDASIA). When that effort failed, they regrouped later in the year, circulating a discussion draft in both the House and Senate that has been under consideration in both houses during the 113th Congress.
Among the most controversial measures contained in SAPA is the level of track/trace granularity. Some proponents had called for a real-time system that could track each drug unit produced, maintaining that such a system would be suitable to combat nearly any situation of fraud it could possibly encounter. In the end, however, that system has lost out to a simpler-and importantly for industry, cheaper-plan that would instead institute a non-real-time database of information that could be probed by regulators, but would only track at the lot level of production.
The legislation calls for a unit level of tracking to go into effect eventually, but the proposed timeframe is much further away than the one proposed by House Democrats. Under the Senate's bill, unit-level tracking would be required within 10 years, while the House would require the same in 14-that is, by 2027.
The law would also override a similar measure that was due to go into effect in California in 2015, opting instead for a national standard for track and trace. The provision was intended to avoid a patchwork of potentially conflicting state laws that could have made compliance much more expensive.
Among the law's other numerous provisions: New licensing standards for wholesale distributors, electronic labeling requirements for drug products, and enhanced penalties for non-compliance.
A similar bill is now working its way through the Senate, which, if passed, would require both houses of Congress to work out differences through a conference committee. An identical piece of legislation would then need to pass the House and Senate and obtain President Barack Obama's signature before being passed into law.