How to Keep Out of Regulatory Quicksand

Pharma sales teams may soon need law degrees just to keep up with the changes in federal and state mandates.
May 01, 2005

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.")

PDMA 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.

QUIZ: Spot the Quicksand
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.

State Regulations 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.

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