US bill sets 10-year deadline for pack-level tracing of medicines

Prospects for federal legislation on medicines traceability in the US have taken a big step forward with the passage of the Drug Quality and Security Act.

The DQSA (HR 3204) was approved by voice vote in the House of Representatives on Saturday and would introduce a federal, serialisation-based track-and-trace system for medicines, as well as new laws covering compounding pharmacies that make drugs to order.

The bill was negotiated between senior House and Senate figures last week and - if adopted - would supersede state-level traceability initiatives, including the electronic pedigree (ePedigree) measures proposed by the California Board of Pharmacy (CBOP).

The DQSA replaces the Safeguarding America's Pharmaceuticals Act of 2013 (HR. 1919) which was cleared by the House Energy and Commerce Committee earlier this year, and has reportedly also been agreed by Senate leaders as an alternative to the Pharmaceutical Quality, Security and Accountability Act  (S.959).

The bill is remarkable in that it is bicameral - supported across both Houses of Congress - as well as bipartisan with support from both Democrats and Republicans. It was also adopted at truly breakneck speed, having only been introduced on September 25 with a comment period of just a few hours.

The key features of the traceability section of the bill (Title II) is that manufacturers will have to add standard numerical identifiers (SNIs) to individual packs and (non-mixed) cases within four years of the legislation being adopted, with electronic tracing of production through the supply chain mandated within 10 years.

Manufacturers should however be able to handle ad hoc verification requests from a repackager, wholesale distributor, or dispenser within four years.

The 10-year timeframe for full pack-level traceability is a somewhat more aggressive timeline than HR. 1919 and has the same 10-year deadline for unit-level traceability as S.959. The earlier House bill was criticised for providing no strict timing for lot-level traceability to be upgraded to a full pack-level system.

Other elements of the bill are largely in line with earlier proposals. For example, the SNI should be in a 2D barcode at the pack level and a linear or 2D barcode on the case, with verification possible with human-readable or machine-readable methods.

It also strengthens licensure requirements for wholesale distributors and third-party logistics providers, with the latter recognised for the first time as a part of the drug supply chain, and asks the FDA to maintain a database of wholesalers that will be available to the public through its website.

However, from January 1 2015 drugmakers should only be working with authorised (registered or licensed) trading partners and have systems in place to provide transaction histories using paper or electronic records, effectively introducing a deadline of a little more than a year for at least a partial drug pedigree system.

The new measures "will allow for efficient tracing to respond to recalls and notices of theft and counterfeiting," Senate Health Education Labor and Pensions (HELP) committee chair Sen. Tom Harkin.

"With the passage of this drug safety bill by the House today, we have a clear example of what Congress can accomplish when both sides come together," he added.

Another proponent of the new bill, Rep. Henry Waxman, said it "maintains the strengths of the groundbreaking California system." The California Board of Pharmacy (CBP) had openly opposed HR. 1919 for not going far enough to protect patients as it set no firm timeline for unit-level tracking.

Traceability elements well-received…

The new proposal has also met with approval from industry, notably the Pharmaceutical Research and Manufacturers of America  (PhRMA), Biotechnology Industry Organization (BIO) and Pharmaceutical Distribution Security Alliance (PDSA), a multi-stakeholder lobbying group which urged "prompt passage of the legislation by the full House and Senate so it can be signed into law by President Obama as soon as possible."

Meanwhile, the Healthcare Distribution Management Association (HDMA) representing wholesalers also welcomed the bill, with chief executive John Gray saying that "only the Senate's imminent vote stands in the way of establishing a federal uniform traceability framework for prescription medicines."

…but could compounding be a sticking point?

While the traceability elements of the DQSA seem to have generally broad support, there are however dissenting voices on the compounding elements (Title I), which includes measures such as the creation of a new category of federally-overseen compounding pharmacies called 'outsourcing facilities'.

Compounding is a massively controversial area in the US as a result of the meningitis outbreak in 2012, linked to the now closed New England Compounding Center (NECC) company - which resulted in more than 60 deaths.

As FDA certification is voluntary - under the bill pharmacies can opt out and stick with state-level oversight - the proposals have met with opposition from the likes of pressure group Public Citizen, which claims this will allow organisations with laxer standards to sidestep stricter scrutiny.

Meanwhile, the International Academy of Compounding Pharmacists (IACP) said in a statement that it would fight the bill as it does not provide appropriate definitions, fails to take into account input submitted to Congress by compounders and "will not further the safety of compounded medication."

It is to be hoped that debate over the compounding elements do not derail the DQSA and interfere with the introduction of a federal track-and-trace system for medicines.