FDA Makes Pharma’s Day with Delay

In this case, an FDA delay is a good thing, as it offers temporary relief to pharma manufacturers by not enforcing the deadline of DSCSA for an entire year

By Katie Weiler, Managing Editor

Who doesn’t love a deadline extension — especially when it comes to paying taxes or meeting new FDA regulations? Some people and companies always adhere to deadlines, making the necessary preparations so they can move on to the next order of business. Others, like me, wait until the last minute, stress the entire time about the looming deadline, and then scramble to meet it — or not — and pay the price.

When the FDA announced it would not be enforcing the Drug Supply Chain Security Act (DSCSA) deadline of Nov. 27, 2017, until one full year later, you could almost hear the collective sigh of relief from pharma manufacturers across the globe.

Of course, the DSCSA compliance deadline should not have come as a surprise to anyone as it was announced back in 2013. In case you’re not familiar with the mandate, DSCSA will require all prescription drugs in the United States to have unique serial numbers to enable track and trace and prevent counterfeit drugs and product diversion. This could be the first time some manufacturers and their supply chain partners ever had to implement serialization and manage serialized product inventory. In fact, it was many of those smaller companies and contract manufacturing organizations who expressed concern to the FDA that they could not have the hardware and software in place to implement serialization packaging by this November. In addition, they cited the long lead times and lack of trained technicians for the serialization equipment.

Even though the FDA granted this extension before penalties would be assessed, the law still requires that manufacturers begin serialization by the original November deadline. On June 30, the FDA released the draft guidance announcing the delayed enforcement period and detailed what the product identifier requirements were under the DSCSA:

• A unique identity for prescription drug packages and cases, which will allow trading partners to easily trace drug packages as they move through the supply chain.
• Includes the product’s lot number, expiration date, national drug code and a serial number. FDA says this unique identifier — human and machine readable — enables product tracing throughout the supply chain and enables all partners to better detect illegitimate products.

So how does the extension affect pharma manufacturers besides giving them more time to meet the regulations?

“With the postponement, companies who have not yet completed the serialization process stand to gain the most,” said Christophe Devins, CEO of Adents. “As awareness grows of the complexity and interconnectivity of the serialization process, pharma manufacturers are realizing the importance of modularity and flexibility in the solutions they choose. The delay also provides valuable time for manufacturers to look beyond short-term compliance needs and consider long-term solution viability.”

According to Brian Daleiden, vice president, TraceLink, this regulation means new systems and processes need to be understood by every department — from Packaging to Quality Control to Engineering. “Serialization and the management of serialized inventory fundamentally changes how your company conducts business,” he says.

Most will agree that the primary goal of DSCSA is patient safety, but it comes at a high cost to manufacturers to implement the necessary changes in their production facilities. In the long run, though, financial benefits could likely surpass the setup costs. Serialization will definitely reduce counterfeit drug costs, although no one will ever know by how much. Take the World Health Organization statistic that estimates pharma loses nearly $40 billion each year globally due to counterfeiting, and that can be used as an overall gauge. Other benefits include using serialization data to help fraud-prone process areas as well as using serialization infrastructure as an additional source of real-time inventory data.

While serialization won’t prevent all instances of counterfeiting, experts agree it will make that crime more difficult as well as enable faster detection of counterfeit products. So don’t delay!

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