Government regulators have never watched pharma sales forces as closely as they do today. On top of familiar reporting
requirements, such as how many samples were given to whom, federal regulators want to know what marketers were thinking. Why,
they sometimes want to know, did a sales rep give one physician more samples than another one down the hall? If they want
more specifics, they can even ask for a rep's call notes. And while the reps are keeping up with federal laws, they have to
learn a new set of regulations for every state in their territory. In some states, for example, nurse practitioners can sign
sample receipts, but in others, doctors must sign personally for their samples.
Even the hardest charging sales reps recognize that paperwork is part of the job, but many top performers always think about
selling first, and filing reports when they can. Putting off the paperwork is tempting, especially if it saves enough time
for an extra office visit or two. But, neglecting the rules of state and federal agencies is dangerous. Careless mistakes
can lead to big fines and deliberate shortcuts—forging the signature of a doctor who's out of the office—can land a sales
rep and his company in criminal court.
Keeping a top-flight sales force up to date requires continuous training in a vast web of regulations including the Prescription
Drug Marketing Act (PDMA); Title 21 Code of Federal Regulations, Part 11 (21 CFR Part 11); the Office of Inspector General
Guidelines for Industry (OIG); the Health Insurance Portability and Accountability Act (HIPAA); and a growing network of
state regulations. (See "Spot the Quicksand.")
The 1987 PDMA, which was revised in 2000, aims to prevent tampering, thwart potential drug diversion, and guarantee the distribution
of safe drugs and sample products to providers and consumers. PDMA reporting requirements have become a (burdensome) industry
standard, but violations still create serious problems. Simple reporting mistakes, including little things like neglecting
to note a date or the number of samples distributed, are considered minor violations, which are punishable by fines. But deliberate
falsifications, such as faking a record, forging a provider's signature, or selling samples to a pharmacist are criminal acts
punishable by heavy fines or prison time.
Manufacturers are creating training programs to keep reps and their managers up to date on PDMA regulations. Compliance consciousness
must become an integral element in daily field-selling routines. Well-trained managers must be prepared to coach and direct
their teams on compliance issues. And, reps must understand the corporate compliance rationale as well as the government regulations.
QUIZ: Spot the Quicksand
Individual state legislatures and pharmacy boards implement regulations to supplement the federal PDMA, so basic regulations,
including rules for sampling midlevel practitioners such as physician assistants and nurse practitioners, vary from state
to state. These providers write more than ten percent of all prescriptions, but reps need to know if their state requires
a collaborative (with a physician) agreement, a delegation of authority letter (from a physician), or specific state paperwork.
Some states have also passed restrictions on or reporting requirements for promotional gifts, personal use programs, scheduled
sample mailings, or the value of samples submitted to storage-location inspections. California has even established OIG guidance
as state law.