Why? A long-standing lack of agreement among the many players - primarily, drugmakers, wholesalers and pharmacies - about a suitable approach. The pharmaceutical industry, for instance, may appear to be a monolithic beast to outsiders, but there is a division among the largest drugmakers over the best course of action, sources tell us. A similar divide exists among large and small wholesalers.
"The conversation has been going on for eight years about what a national system would look like," says Allan Coukell, a pharmacist and director of the medical programs at the Pew Health Group, who will testify at the House Energy and Commerce Subcommittee on Health hearing (see this). "Short of legislation, I'm afraid, it's clear we aren’t going to get a single national system."
A key sticking point, not surprisingly, is cost. To implement a uniform system that would allow each player to follow every shipment in the supply chain - a method called track-and-trace - means that an investment must be made to purchase equipment. For instance, scanners for warehouses, trucks and pharmacies would be needed for reading bar codes placed on every bottle in each lot that is shipped.
Adopting such an approach would, presumably, help to plug the gaps that are exploited by counterfeiters. More than 30l states have passed laws requiring so-called pedigrees, a reference to steps taken to prove proper possession of medicines along the supply chain. Only California, though, has passed a law that requires a universal standard for track-and trace technology at the unit level (read here, here and here).
The California legislature actually passed a bill in 2004, but a deadline for implementation was moved back several times. Why? Behind-the-scenes disagreements among drugmakers, wholesalers and pharmacies. In August 2008, nearly three dozen of these players, along with their trade groups, sent a letter to the California Secretary of State to express their support for the bill.
But not every company was on board. Among the names that did not appear: GlaxoSmithKline, AstraZeneca, Roche, Eli Lilly, Sanofi, CVS and AmerisourceBergen. "There are huge divisions," one source, who is familiar with the long-running negotiations over uniform standards, tells us. "The argument is always that the technology isn't ready or fully vetted or is cost-prohibitive."
There is some irony in this, of course. The pharmaceutical industry has railed against buying medicines over the Internet or over the border in Canada or Mexico, arguing that the real source of these drugs cannot be verified. Yet these same drugmakers are unable to agree on a system to stop a problem for which, as a group, they may take the blame if counterfeiting one day causes a true catastrophe.
Meanwhile, the California law now goes into effect in 2015. This may seem far away, but this also raises the prospect that other states may be motivated to follow suit in the interim. And the last thing that drugmakers, wholesalers and pharmacies want is a nationwide patchwork of state laws that may require different investments and practices.
"We are concerned about the possibility of a patchwork of potentially conflicting state laws addressing pedigree systems," Kendra Martello, assistant general counsel at PhRMA told a House Energy & Commerce Subcommittee last week (read here). "...While electronic systems or technologies may serve a deterrent effect, there is no one single technology or electronic system that would be a 'silver bullet' to prevent diversion from the regulated supply chain."
Not surprisingly, there are competing proposals. A bi-partisan bill introduced in the House last fall by Brian Bilbray, a California Republican, and Jim Matheson, a Democrat from Utah, largely mirrors the California law (look here). Separately, a coalition of 27 drugmakers, wholesalers and pharmacies called the Pharmaceutical Distribution Security Alliance is floating a similar proposal, although it lacks a mandate for companies to track drugs at the unit level (read this).
"We have concerns with the PDSA proposal," says Coukell. "It doesn’t require anyone to authenticate products. A problem wouldn’t automatically be detected. There's no routine flag for stolen or counterfeit product. It requires tracing at the lot level, but not after that... Lots get split up and sent to multiple wholesalers and pass through different sets of hands... But this doesn’t give us a lot of granularity."
We contacted the PDSA to discuss its proposal, but did not receive a response. We asked PhRMA about which approach the trade group was willing to support -the Bilbray-Matheson bill, which is also known as Safeguarding America's Pharmaceutical Act, or the PDSA proposal. PhRMA senior vp Matt Bennett sent us a middle-of-the-road reply saying "...while we are still reviewing the bill, we are actively working through PDSA on a stakeholder solution that all stakeholders can agree to.”
[UPDATE: A PhRMA spokeswoman adds that the trade group, which supports the PDSA proposal, also advocates a closed US drug supply system; increasing jail sentencing for criminals caught selling counterfeits – to at least 20 years; increasing licensiing requirements for distributors and bolstering oversight on repackagers.]
An agreement, however, appears likely to take still more time. Meanwhile, the counterfeiting problem remains.
pic thx to safemedicines.org