Track-and-Trace Initiative Coming to the Pharmaceutical Industry

By Mike Rozembajgier

Like it or not, track-and-trace may soon be a reality for the pharmaceutical industry. Earlier this month, the Obama administration recommended implementation of a track-and-trace initiative as part of a package of proposals designed to fight counterfeit drugs and protect consumers. While several industry organizations have expressed concerns about the cost involved, if there is anything recent regulatory events can tell us, it is that companies are better off running to the light and embracing new consumer protection mechanisms than pushing back against regulators.

The National Association of Chain Drug Stores (NACDS), while supporting parts of the Administration’s proposal, has made clear its opposition to the track-and-trace idea. NACDS’s objections are based primarily on the fact that such systems are still under development and may not be effective in their current state, and that they would be too expensive for pharmacies and supply chain operators to implement.

At the same time, however, PhRMA, the national association representing drug manufacturers, is supporting, in general terms, the government’s focus on collaboration and information sharing “as it relates to counterfeit pharmaceuticals.”

Needless to say, there is widespread public support for protecting consumers and fighting counterfeit drugs, but the industry’s concerns are legitimate. Nevertheless, particularly as recall enforcement events, legislation, and regulatory oversight continue to expand, companies have little to gain from fighting new consumer safety recommendations.

Instead, as we have often recommended, the most successful approach is to beat regulators to the punch. If a company or industry does not approve of the precise mechanism the government wants to implement, try developing, launching, and publicizing your own version before the government. Doing so not only demonstrates a commitment to consumer safety – before regulators mandate it – but also enables companies to play a role in determining just how the details take shape.

When it comes to track-and-trace requirements – as well as other regulatory advances – companies should not simply sit back and wait for the government to issue mandates. By taking the lead and getting out in front of both regulators and public opinion, companies can protect consumers and their reputations.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.