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
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
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.