Drug Quality and Security Act- New US Legislation for Pharma Tracking

Gerald Clarke

Don’t be distracted by news of a ‘shutdown’ in the American government, some of the biggest news from the pharmaceutical legislation perspective is not related to the inability to pass a budget.

Unlike the ‘Obamacare’ healthcare legislation which is dividing congress, the Drug Quality and Security Act enjoyed bipartisan support and was passed in the House with Senate passage all but a certainty. It also will supersede moves by the California Board of Pharmacy which had published suggested regulation of drop shipments under ePedigree law.

Efforts to secure supply chains have been underway for almost a decade, with several high profile cases of falsified medicines in the early 2000’s and gaining wider recognition with the publication Of Katherine Eban’s book Dangerous Doses in 2005. Several high-profile product recalls, product contamination scandals and a marked increase in counterfeit drug activity had resulted in a spate of activity in the US at all levels, including the FDA whose Counterfeit Drug Task Force published its final report in advocating mass serialisation – at the time on the basis of the EPC and RFID -  that would allow full traceability through the supply chain, “an electronic pedigree from the point of manufacture to the point of dispensing.”

 The Drug Quality and Security Act combines legislation for supply-chain traceability with legislation aimed at covering a previous regulatory blind-spot, compounding centres. It is likely that the addition of the compounding centre title to the bill aided its passage, as following the New England Compounding Centre (NECC) fungal meningitis outbreak, regulating these grey-area manufacturers enjoys wide support.

The NECC outbreak occurred when a large compounding centre failed to maintain sterile conditions in its compounding of products including steroids for injection. The resulting outbreak led to the deaths of 64 people across the US and 750 confirmed cases of illness including stroke, meningitis and spinal or paraspinal infection.

The first title of the bill dealing with compounding regulation makes provisions for compounding centres to voluntarily register as an ‘outsourcing facility’. Registration will cost $15,000 and a further $15,000 will be used to fund inspections of outsourcing facilities. Pharmaceuticals coming from a compounding centre will also have an additional requirement on packaging to state “’This is a compounded drug’  or a reasonable comparable alternative statement (as specified by the Secretary) that prominently identifies the drug as a compounded drug”.

 The second part of the bill concerns drug supply chain security. This sections sets out standards for prescription drug wholesale distributors as well as for third party logistics providers. Those involved in the supply chain will have to be registered and provide tracking and labelling of pharmaceutical, initially at batch-level, though stepping up the requirement to traceability at item level over a 10 year timeframe, including the participation in an electronic system for tracking at the unit level. The collection and storage of tracking information is also a requirement under the bill for dispensers.

 Pharma IQ today spoke with Christoph Krähenbühl, managing director of 3C Integritywho expressed the desire manufactures have to be presented with a clear, authoritative and unified approach to this problem to avoid uncertainty. If, for example, California fights to have its own regulations when it comes to traceability, the US risks disunity of regulations. The Californian market is so large and a company can’t in practice control where its drugs go, so they will have to ensure all shipments pass the higher Californian bar of traceability. Krähenbühl said “The problem with the uncertainty is that it creates the impression that the best course of action is to wait and see when, in fact, companies are advised to not delay embarking on their programs to establish the basics serialisation and traceability capabilities now.”

  The bill’s passage is worthy of commendation, especially since similar bills have struggled in the past, however some may point out the obvious concessions in the bill. The voluntary regulation of compounding centres, for example, is one which may attract some criticism, however the bill has yet to pass the Senate and so criticism based on the success of the bill is so far unfounded. The other concession is the decision to require tracking on the lot level rather than the unit or individual level. The 10 year delay before moves to unit level electronic tracking is a very long time even by Congress’ standards. When asked if it would take 10 years to lay the groundwork for a unit-level tracking system Krähenbühl replied “my personal view is no, not at all.” He pointed out that the tracking requirements had been and were being introduced in other countries, including across all 29 EU Member States as required by the EU-Falsified Medicines Directive and that preparing for item-level tracking is the inevitable first step companies need to master anyway. When asked if this was something companies would be willing to do he said “taking Turkey for example, when faced with the choice of comply or give up the Turkish market, they will find ways”.

 Once the bill passes the Senate (if negotiation over the government shutdown doesn’t delay it) we will likely see further moves and reaction to the bill. In the end it appears to be a step in the right direction and specific qualms about precisely how the bill is carried out are less important than the bill’s introduction in the first place. Krähenbühl summarised the situation pithily “if you’re going from London to Newcastle, the most important thing is to head north. What streets you drive down in Newcastle is something you can think about when you are getting there.”