The Road from PDMA to DSCSA in Pharmaceutical Packaging
The year was 1987. It seems quite a while ago. This was when then-President Ronald Reagan signed the Prescription Drug Marketing Act (PDMA). This was the first passed legislation including the concept of pedigree for pharmaceuticals. It was also the precursor to the 2013 Drug Supply Chain Security Act (DSCSA) signed by President Obama.
Look at the progress in our world since 1987: airbags, anti-lock brakes, cell phones, the internet, e-mail, texting, GPS, lane-departure warning in your car, auto-braking. Onstar for remote help at any time, whether you’ve had an accident, are lost or even locked your keys in your car.
The idea of the PDMA was to gain visibility into the movement of pharmaceuticals in a rapidly expanding supply chain. The supply chain was tiny by today’s standard, only approximately $40 billion versus $338 billion.1 This basic safety action was the equivalent of putting headlights on the early cars. Let’s see where the drugs have been.
The industry balked, especially the small distributors. The act had its teeth pulled. Then in the early 2000s, it became apparent that something was wrong. Katherine Eban’s book Dangerous Doses framed the situation well. Now, people are dying and we can see how. Some great detective work began to uncover a network of secondary distributors, black market profiteers and counterfeiters that were running amuck in a largely unregulated space between pharma manufacturers and the pharmacy. Pharmaceutical distribution was the open barn door.
Suddenly some states (not surprisingly, some discussed in Dangerous Doses) began to take the problem onto themselves. Not only did they want seatbelts for the pharmaceutical packages but maybe a primitive GPS wouldn’t be a bad idea. Florida and California revived the concept of pedigree first laid out in PDMA. Florida, taking the quickest path, selected paper pedigree before understanding the logistical nightmare that it would cause. California opted for electronics but also wanted to include serialization to allow electronic tracking. Ahh, seatbelts and limited GPS to go with the headlights. A nice touch.
This was a concern for the pharma industry. Florida represented 15 million plus people and California more than 39 million—each state creating their own definition of seatbelts, going in different directions with states jumping on board with their own variations. All of these people want seatbelts with some form of GPS, and we were heading for 50 different versions.
So the pharma industry began to push for national legislation to thwart all of these individual efforts and get to a common path, one seatbelt designand, hopefully, not too expensive. The other very real part of this is that the industry has a much better chance of influencing the outcome in D.C. vs. 50 individual states.
The result was DSCSA, rolled out in 2013 with the industry hoping that the FDA would blink and put some delays in place, as California had before federal legislation pushed their law aside. FDA hasn’t blinked.
Jump to today and the opioid discussion. Now, FDA, and soon Congress, will say seatbelts are not enough. They will require the appropriate package—a blister—at least for initial scripts. Hopefully those involved will see the benefit of taking it further to all opioid scripts, whether initial or chronic care. Blister packaging and, hopefully, serialized blisters could do wonders for improving supply chain safety. Not only will we get seatbelts from this change but we will attain several other safety features: product tracking, improved product safety (stability), improved patient handling (adherence) and improved caretaker oversight via recognition of doses taken.
Only 31 years after PDMA, and we are at last moving to secure our pharmaceutical supply chain and improved safety for our patients. Not quite Onstar for your drugs but a step in the right direction. Ladies and gentlemen, fasten your seatbelts.