The FDA’s latest draft guidanceon theDrug Supply Chain Security Act’s (DSCSA)product identifier requirements gives pharmaceutical manufacturers a little breathing room, as enforcement of the original November 2017 deadline gets pushed back a year.
But this news should not inject indolence into the industry because, the reality is, nothing has changed except that companies won’t be facing enforcement of the requirements—until November of 2018.
To be clear: the law remains intact and this should not be seen as a sign that the FDA is easing off the industry—at all. In fact, I asked a few industry experts what this change means, and it seems to be a “friendly gesture” by the FDA to give the companies that are way behind in compliance some more time. But there are no free rides here. In fact, it just means stricter enforcements in the future.
“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,” said Dave Harty, vice president of professional services atAdents, a maker of unit identification serialization and traceability software.
“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,” Harty explained. “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.”
Peter Sturtevant, senior director of industry engagement forGS1 US,agrees. “Even though it may seem like manufacturers have the luxury of an additional year, the FDA’s enforcement delay has no direct impact on the Act itself. It would require an act of Congress to change DSCSA,” he said. “The question for manufacturers now becomes, when November 27th approaches, ‘do we want to be compliant with the law or not?’ The FDA announcement means it will not enforce any penalties on manufacturers for non-compliance of the serialization requirement, but it still makes good business sense for manufacturers to continue to prepare their production lines for serialization.”
Indeed, the law is not expected to change, even though there’s been industry speculation that the Trump administration is angling to eliminate regulations that burden businesses unnecessarily. But this law is not about creating problems for pharma companies. Rather, it is meant to protect the consumer by keeping counterfeit products out of the supply chain.
The next obvious observation, however, is how this will impact the downstream deadlines for repackagers (November 2018), distributors (November 2019) and dispensers (November 2020), which must comply with the same serialization mandates.
“There is a strong possibility downstream trading partners will experience cascading discretionary delays as a result of this announcement, as we saw this happen the last time there were discretionary enforcement delays on two different occasions for phase one of DSCSA for the lot-based requirement,” Sturtevant said.
Similarly, Dirk Rodgers, a regulatory strategist with Systech International and the founder of RxTrace,noted in an article that,“by not enforcing the manufacturer’s requirement to apply the new DSCSA product identifier on all drug packages by this November, the FDA is forced to soften some of the deadlines for other segments of the supply chain.” But, he added, the new draft guidance makes it clear that the repackager, distributor and dispenser deadlines will still be enforced for products that the manufacturer introduced into commerce with the new DSCSA product identifier before November 27, 2017.
In addition, Rodgers noted that other than product identifier enforcement delays, manufacturers should be aware that there are a number of requirements that will still go into effect on November 27, 2017. In his article, Rodgers stated: “Manufacturers must begin to provide the transaction information, transaction history and transaction statement in electronic format only, except when selling directly to a licensed healthcare practitioner who is authorized to prescribe medication under State law, or to other licensed individuals who are under the supervision or direction of such a practitioner who dispenses product in the usual course of professional practice.”
这里的底线是,什么都没有改变,because, as noted, Congress set the deadlines and only Congress can change the deadlines. Rodgers pointed out that since the FDA is the agency that enforces the law, “they can choose to enforce it selectively—particularly to minimize possible disruptions in the distribution of prescription drugs in the United States.”
For now, the FDA—and hopefully the industry—isstill on track to meet the 2023 deadlinefor full serialization interoperability with track and trace for all supply chain trading partners.
So, pharma manufacturers, take a breath...but keeping moving forward on this—quickly.
