Update: US Senate clears track-and-trace bill

The US Senate passed H.R. 3204 by unanimous voice vote today, bringing a national track-and-trace system for medicines and new laws governing compounding pharmacies to the brink of fruition.

With the House having given its blessing to H.R. 3204- also known as the Drug Quality and Security Act (DQSA) - at the end of September, all that remains now is for the bill to be passed to President Obama for signature.

The legislation introduces a federal track-and-trace system for medicines with serial numbers added to individual packs and (non-mixed) cases within four years of the legislation being adopted, and electronic tracing of production through the supply chain mandated within 10 years.

It also strengthens licensure requirements for wholesale distributors and third-party logistics providers, and asks the FDA to maintain a database of wholesalers that will be available to the public through its website

Crucially, the bill supersedes the electronic pedigree (ePedigree) measures proposed by the state of California, rendering them obsolete and resetting the timelines for serialisation compliance.

"It will take several years to implement, but eventually the four billion prescriptions written each year will be traceable from manufacturer to pharmacy," said Health, Education, Labor, and Pensions (HELP) Committee  ranking member Senator Lamar Alexander (R-TN) in an address to the floor this afternoon.

H.R. 3204 also boosts oversight of compounding pharmacies that make drugs to order, with the FDA getting greater powers to oversee large-volume or 'outsourcing' compounders without individual prescriptions. The aim is to avoid a repeat of the meningitis outbreak in 2012 - linked to the now closed New England Compounding Center (NECC) company - which resulted in more than 60 deaths.

Commenting on the passage HELP Committee Chairman Tom Harkin (D-IA) said: "This bipartisan bill represents a monumental step forward for drug safety and is a testament to what Congress can achieve when Democrats and Republicans work together."

"Americans must have the confidence that their drugs - whether obtained at a hospital, at a doctor’s office, or at the pharmacy counter - are safe, and that is exactly what this bill does," he added.

The expectation now is that Pres. Obama will sign H.R. 3204 into law within the next few days, although there is still a theoretical (but unlikely) chance that he could choose to veto it.

Reactions:

"The legislation will provide protection to consumers in the short-term while permitting expansion and enhancement as new technologies are developed," commented Vince Ventimiglia of the Pharmaceutical Distribution Security Alliance (PDSA), a coalition of more than 25 stakeholders spanning the pharmaceutical supply chain. "The US will have a single, uniform and national solution, one that will strengthen and enhance current safeguards to ensure all American healthcare consumers are better protected from the grave threat of counterfeit, fake and adulterated pharmaceutical products," he added.

Healthcare Distribution Management Association (HDMA) chief executive John Gray described the federal pre-emption of state laws as "one of the most significant legislative accomplishments for our industry." adding it is "especially important for the healthcare providers and pharmacies - and their patients - who count on the safe and efficient distribution of prescription medicines."

Pharmaceutical Research and Manufacturers of America (PhRMA) president and chief executive John Castellani said: "The counterfeiting of prescription drugs is on the rise within the US but oftentimes goes unnoticed or unreported, leaving many Americans unaware of this problem. We look forward to working with the FDA to appropriately implement this Act, which will foster the strong level of protection for pharmaceuticals that our citizens have come to expect."

Scott Davis, chairman and CEO of third-party logistics company UPS said the passage of the DQSA is "a giant step forward for the safety of America's drug distribution network and our supply chains," adding that the "creation of uniform federal standards will reduce regulatory complexity, while the addition of track-and-trace measures will add transparency and accountability."