With the mercury set to fall in the US capital of Washington, DC, after a relatively uneventful few months, the stage is slowly being set for a number of legislative issues pertinent to the regulation of healthcare products to return to the congressional spotlight.
But while much attention is likely to be paid to pharmaceutical compounding, at least one senator is trying to make sure the safety of the pharmaceutical supply chain doesn't get placed on the backburner for a second consecutive year.
Pharmaceutical "track and trace" is a collection of tools employed to make sure regulators and companies can determine the authenticity, identity and whereabouts of a particular drug product. It is so named because, under an ideal system, regulators would be able to track where a product is going in the supply chain and trace where it has been.
While track and trace has experienced broad support among legislators, its particular details have been a source of frequent serious debate.
During the 2012 debate over the Food and Drug Administration Safety and Innovation Act (FDASIA), legislators seriously considered but ultimately dropped a track and trace provision from the bill at the last minute over at least three major concerns: Who might pay for a system if it were to be implemented, the level of granularity required to be tracked (lot level or unit level), and what the system might look like (a real-time system or serialization with barcodes and databases).
Rather than risk the broad-based support that FDASIA enjoyed, proponents of track and trace decided to sideline the measure, leaving it to either be treated as a stand-alone bill or bundled up into another piece of healthcare legislation.
At the time of the provision being dropped from FDASIA, some in industry speculated that track and trace could find its way into the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), another huge piece of legislation passed in 2013 that provided new funding and authority for FDA to carry on its biodefense regulatory activities. Track and trace was not, however, among the bill's many provisions.
More recently, two prominent pharmaceutical industry associations, the Pharmaceutical Research and Manufacturers of American (PhRMA) and the Generic Pharmaceutical Association (GPhA), issued a call for the revival of track and trace, saying recurring examples of counterfeit products entering the US supply chain illustrated the sort of vulnerabilities that track and trace would be able to shore up.
"Now is the time to pick up where the previous FDASIA effort left off," they wrote in an opinion-editorial in Politico.
Congressional Progress Thus Far
Since industry has weighed in, Congress has seen major activity with respect to the measure in both the House and Senate.
Just before Congress went on recess in August, the House of Representatives passed a track and trace bill, which was then passed on to the Senate. The Senate, meanwhile, has already lent its general support to the measure, as has the US Food and Drug Administration's (FDA) top drug regulator, Janet Woodcock.
Despite an eye toward passage of the measure in July, the legislation remains in limbo, with the Senate yet to act on the House track and trace bill. And that has at least one prominent senator worried.
Senator Burr: Get This Thing Passed
In a statement released on 11 September 2013, Sen. Richard Burr said the issue was one that would have a strong impact on the day-to-day lives of Americans in quiet but profound ways. But despite the issue of drug supply chain safety not getting much attention in the popular media, Burr said Congress would be unwise not to heed "early warning signs" that speak to a potential crisis.
"Last year's meningitis outbreak is such an example," continued Burr. "As the tragic events over the past year surrounding the outbreak have reminded us, patients deserve the peace of mind that the medicine they take will meet their needs. Patients expect the prescription drugs that they take to be safe and effective, and they and their doctors do not think to question the security or safety of the supply chain through which the drug traveled."
But despite FDA's repeated warnings, Congress has repeatedly failed to enact reforms to introduce track and trace measures to the system, Burr explained.
"The absence of a uniform, federal approach invites criminals to take advantage of the states with the lowest supply chain security requirements. The need to establish a strong, uniform prescription drug-tracing standard that reflects today's realities is clear."
Burr urged his colleagues to take up his Pharmaceutical Quality, Security and Accountability Act (PQSA) this fall.
Potential Stumbling Blocks
However, one stumbling block may yet emerge. The Senate PQSA contains measures to address both track and trace and pharmaceutical compounding. The House of Representatives, meanwhile, is considering the issues on a separate basis due to significant controversy regarding whether FDA really needs additional compounding authority.
This raises three distinct options:
- The Senate passes the track and trace legislation, which is then adopted in the House.
- The House version of track and trace is adopted in the Senate, which then considers pharmaceutical compounding reforms on a separate basis.
- The bill fails to pass.
Whatever the result, congressional time and attention are slipping away quickly. The House has just 35 working days left in the calendar year, and other political issues such as events in Syria, a budget resolution and the opening of healthcare exchanges under the Affordable Care Act all promise to demand political attention.