The thornier side of PDMA
To marketing people in the pharmaceutical industry, the Prescription Drug Marketing Act (PDMA) lists numerous government regulations related to prescription drug samples: How they're tracked and monitored in a linear fashion all the way from the manufacturer, to the fulfillment house, to the sales rep and finally to the physician's office.
But the PDMA, as passed by Congress 20 years ago, is much broader in scope than just sampling. Roughly half of the legislation regulates the distribution of non-sample prescription drugs, which remains a far murkier issue. Resembling a giant web that is incredibly difficult to track and monitor, the US drug distribution system is rife with gaps, allowing a drug's traceability to be lost, incomplete or outright fraudulent.
Breaches within the distribution system have led to problems plaguing pharma companies, such as counterfeiting and diversion, which continue to 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 system should be traceable back to the original authorized manufacturer. In the parlance of the industry, a drug product should have its own “pedigree” from manufacturer to pharmacy, just as a familial heritage is traceable through an ancestral tree.
While the PDMA does address the importance of pedigrees, the act's language—as authored by Congress—makes pedigree enforcement extremely difficult. There are more than 4,000 wholesale drug distributors, with the three largest handling roughly 90% of the business. Under the PDMA, only unauthorized distributors must provide pedigrees as prescription drugs travel through the distribution chain. Authorized distributors are not required to provide pedigrees to wholesale customers.
For these reasons, states are being forced to enact their own pedigree laws. Florida was the first to not allow any drugs to cross its borders without a complete, accurate pedigree document. With each state creating its own pedigree requirements, the industry may face 50 different sets of standards and formats.
Drug manufacturers, as well as state and federal governments, also must be concerned with drugs coming into the US from other countries. In the case of Canada, government officials there have freely admitted they do not inspect any drugs entering Canada unless the drugs are intended for their citizens.
This means that all drugs entering the US from Canada have suspect pedigrees. Recently, FDA/US Customs and Border Patrol “blitzes” have found numerous examples of drugs purported to be from Canada that actually were manufactured in such countries as Thailand and China.
In the coming months, Congress has the opportunity to pass stricter federal legislation to ensure all prescription drug products are traceable. This not only would help safeguard our nation's prescription drugs, but it also would help our pharmaceutical companies succeed in the global economy.
Peg O'Rourke is is a senior regulatory consultant at Cegedim
Dendrite's Compliance Solutions division. Last October, she retired after 35
years at the FDA, where she oversaw the agency's PDMA enforcement efforts.
Peg O'Rourke is is a senior regulatory consultant at Cegedim Dendrite's Compliance Solutions division. Last October, she retired after 35 years at the FDA, where she oversaw the agency's PDMA enforcement efforts.