The industry has been talking about, and slowly working toward, track-and-trace for many years. Now Pharma faces real deadlines that require action.
There are different players in the mix, and they face different deadlines for meeting requirements. The most pressing deadline for pretty much everyone, however, is the mandate that they begin tracking prescription drug lots starting in 2015. Two years later, the industry must begin assigning serial numbers to individual "saleable units" of every prescribed product sold in the U.S. Anticipating this, some players are wondering: "What do I do now?"
"I think an accurate snapshot is that most manufacturers have invested time, and in some cases substantial resources, in serialization," said Allan Coukell, a drug-policy expert at the Pew Charitable Trusts who has followed the progress of track-and-trace over the years. "The wholesalers are further behind, and the pharmacies have not started planning."
The FDA has to come up with some guidelines before the Jan. 1, 2015, start date, which means the time between getting those published and the deadline to meet the letter of the law may be razor-thin--probably not long enough for anyone to actually get what they need in place. Some experts, like consultant Dirk Rodgers, founder of RxTrace and an independent consultant, have a hunch the FDA may find a way to fudge the 2015 start date to accommodate the smaller players who are unprepared, but there is no guarantee. That has led to concern that some companies, panicked by the impending deadline, will rush out and buy some technology from the first vendor that calls and that they may be making a costly mistake.
The people with whom I have spoken agree that regardless of which category companies fall into and what deadlines they face, the best approach is to step back, take stock of what technology and processes they have and how they will adapt to the new law. Then they can start making informed decisions of what is needed to fill in the gaps.
The law calls for eventually having in place an electronic tracking system that can trace individual units for recalls or other problems, but electronic tracking is not required up front. Some small players may think they can meet the letter of the law by simply including a paper pedigree in their shipments. But those deeply enmeshed in the law suggest players need to think not only of what they must do to comply but what their partners up- and downstream of them will need.
Rodgers says wholesalers, especially the big players, are going to want everyone to get to an electronic system as quickly as possible. "The volumes we are talking about for the big wholesalers are so massive that the idea you can create a piece of paper and provide a copy to your customer, well, that will not work in large volumes," Rodgers said recently. "That is why wholesalers have 6 years before they have to pass along a true history."
Brian Daleiden, vice president of marketing for solution provider TraceLink, says paper documents are not going to be practical for very long anyway. He points to a provision of the law that says players will have to be able to retrieve and provide to a regulator documents on a suspect product, for example, within 24 to 48 hours. "If you try to do that via paper, how do you respond if, say, you are shipping product from 6 locations?"
Daleiden thinks the industry will spend the rest of the year taking stock of the new law but said the customers TraceLink has been talking with are not going to just wait for the FDA before moving forward. They have been working on this for some time, and they are going to figure out on their own what they need to do. He said there is a movement to get the FDA to coalesce around some electronic standards that ensure that systems at each point along the supply chain can capture and pass along the required information electronically. Opinions differ about what those standards should be, but different players representing different segments are confident they can come together and make this happen.
"It is not going to be easy," Daleiden said. "There will be some investment, whether in technology systems or processes, and there will be change. Yes, there will be some short-term pain. But on the flip side, there is a sense of relief over the certainty. Now there is a plan going forward with dates certain that companies can invest against."
Coukell is generally of the same opinion. He thinks the timelines for implementing the provisions of the new law need to be watched carefully but are realistic. He says the law is self-effectuating. He and others say that the industry has planned for something to be in place for years, prompted initially by the California pedigree law that was made moot by the federal legislation. Those players who have been at the forefront will figure out what needs to happen and lead those who are not sure how to proceed. -- Eric Palmer (email | Twitter)