What will postponing the DSCSA November 2017 enforcement deadline entail? The Adents Expert View
The US Food and Drug Administration (FDA) published on June 30th a new Guidance document on Product Identifier Requirements Under the Drug Supply Chain Security Act (DSCSA). Albeit in draft mode, the document clearly states that the “FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before November 26, 2018. This represents a one year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers.”
New FDA draft Guidance document postpones serialization deadline
In short, pharmaceutical companies and CMOs producing prescription medicines will not be penalized if they do not meet the upcoming serialization deadline of November 2017. But, and this is very important, the original deadline remains unchanged. You still are legally required to serialize prescription medicines intended for distribution to the American market before the end of the year. Furthermore, at this point in time, all other timelines and requirements are intended to stay in place as far as re-packagers in 2018 and return requirements of 2019 go and, of course, the full enforcement of all DSCSA requirements from 2023.
Drug Supply Chain Security Act (DSCSA) remains valid
Postponing its enforcement rather than delaying the official compliance deadline is a deliberate and very clear signal from the FDA that the law remains in place and is not going to go away or suffer multiple further delays. After all, the law is intended to make the drug supply chain safer and, ultimately, save patients’ lives by protecting them from counterfeit medicines. It is more than likely that this suspension of enforcement for 12 months will entail a complete zero-tolerance approach in 2018 as anyone not in compliance would technically have been in violation of the law for a full year.
Serialization remains a challenge
As many if not most drug manufacturers catering to the American market still have no viable, scalable and future-proof serialization solution in place , the industry will welcome this respite. Serialization impacts a great many areas of a business and changes operations from the packaging line, supply chain, and the entire lifecycle of the business. Indeed, many companies underestimated the breadth of impact that serialization can have on an organization. In other cases, solutions were selected that required customization or extensive services work to implement. Those proprietary solutions result in extensive delays on the vendors’ side. Some solution providers utilize deployment approaches that simply do not scale to spikes in demand and the time and effort to recruit, hire, and train internal teams can overwhelm many smaller companies with no experience in scaling for a market spike. This is very much like the Y2K era and the initial dot-com rush. Only solution providers with an extensive network of highly skilled solution partners will be able to meet the industry’s demand when deadlines become imminent (again).
DSCSA delay as an opportunity
For pharmaceuticals manufacturers with no solution installed yet, this is a tremendous opportunity as many that have made selections or decisions they have come to regret, but felt trapped by the deadlines and unable to make a change. Now they can carefully rethink their decisions, learn from what has been happening in the industry all around them, and hopefully find a better way forward.
Those who are currently equipped will have the advantage of working though the learnings and impacts while not under a penalty threat to accommodate and adjust as needed and will be in the best position to run their businesses in the most effective way once the enforcement period commences.
Impact on serialization solution vendors
For some serialization providers, this will be an opportunity to re-engage with customers who had made a selection they regretted and finish projects they are very far behind schedule on. In some cases, it will not fare well as customers now have more options together with an, at least technically, extended deadline and will look to find providers who can honor their commitments and provide the support they were not able to get from their original vendor.
Postponed is not repealed – take action now!
However, even if you seem to have more time now, don’t be fooled into thinking this will make things easier. It will certainly alleviate some of the pain points but serialization implementation is not just a matter of time. A successful serialization implementation program depends on a number of factors: choosing the proper solution for your business environment, the vendor who can actually meet the commitments he makes and the willingness of everyone concerned in your company to move forward. While large companies have some challenges in getting all their affected lines equipped, there are a disproportionate number of smaller players who still have not even started on their solution and that approach will continue to leave a segment of the market unprepared for 2018.
You can read the full text of the original guidance document published by the FDA on the FDA’s official website.