To marketing people in the pharmaceutical industry, thePrescription Drug Marketing Act (PDMA) lists numerous government regulationsrelated to prescription drug samples: How they’re tracked and monitored in alinear fashion all the way from the manufacturer, to the fulfillment house, tothe sales rep and finally to the physician’s office.
But the PDMA, as passed by Congress 20 years ago, is muchbroader in scope than just sampling. Roughly half of the legislation regulatesthe distribution of non-sample prescription drugs, which remains a far murkierissue. Resembling a giant web that is incredibly difficult to track andmonitor, the US drug distribution system is rife with gaps, allowing a drug’straceability to be lost, incomplete or outright fraudulent.
Breaches within the distribution system have led to problemsplaguing pharma companies, such as counterfeiting and diversion, which continueto harm the industry’s reputation and bottom line. To plug the holes,congressional action, FDA enforcement and industry cooperation are necessary.
Ideally, a drug’s path through the distribution systemshould be traceable back to the original authorized manufacturer. In theparlance of the industry, a drug product should have its own “pedigree” frommanufacturer to pharmacy, just as a familial heritage is traceable through anancestral tree.
While the PDMA does address the importance of pedigrees, theact’s language—as authored by Congress—makes pedigree enforcement extremelydifficult. There are more than 4,000 wholesale drug distributors, with thethree largest handling roughly 90% of the business. Under the PDMA, onlyunauthorized distributors must provide pedigrees as prescription drugs travelthrough the distribution chain. Authorized distributors are not required to providepedigrees to wholesale customers.
For these reasons, states are being forced to enact theirown pedigree laws. Florida was the first to not allow any drugs to cross itsborders without a complete, accurate pedigree document. With each state creatingits own pedigree requirements, the industry may face 50 different sets ofstandards and formats.
Drug manufacturers, as well as state and federalgovernments, also must be concerned with drugs coming into the US from othercountries. In the case of Canada, government officials there have freelyadmitted they do not inspect any drugs entering Canada unless the drugs areintended for their citizens.
This means that all drugs entering the US from Canada havesuspect pedigrees. Recently, FDA/US Customs and Border Patrol “blitzes” havefound numerous examples of drugs purported to be from Canada that actually weremanufactured in such countries as Thailand and China.
In the coming months, Congress has the opportunity to passstricter federal legislation to ensure all prescription drug products aretraceable. This not only would help safeguard our nation’s prescription drugs,but it also would help our pharmaceutical companies succeed in the globaleconomy.
Peg O’Rourke is is a senior regulatory consultant at CegedimDendrite’s Compliance Solutions division. Last October, she retired after 35years at the FDA, where she oversaw the agency’s PDMA enforcement efforts.