ANSWERS

21 CFR Part 11 In 1997, the federal government passed 21 CFR Part 11, partially in response to requests by manufacturers and vendors to be able to submit electronic sample records instead of paper. The government has published and recalled these guidelines twice since then, and a third revision is currently pending. The rapidly changing regulations pose one challenge for companies. The different electronic platforms favored by physicians create another headache.

Although the burden of responsibility for 21 CFR Part 11 ultimately lies with companies, reps are responsible for producing valid, reliable data. Policies must be established to hold reps and their managers accountable for accurate reporting; they should be terminated for non-compliance. Reasonable guidelines might include requiring that reps file data every week, capture signatures electronically, and store data on a laptop computer provided by the company. If reps were to file data less often, provide only paper signatures, or use their personal computer to store data, they would be considered non-compliant and could be terminated.

OIG When the OIG was charged with preventing fraud and abuse in the federal healthcare system, its 2003 guidelines effectively became a new set of regulatory hurdles for pharma manufacturers. Today, in addition to documenting how they promote products, marketing departments and field reps must, for the first time, demonstrate the "intent" of their marketing activities.

For example, if reps visited five doctors and distributed five hundred samples before the new OIG regulations went into effect, they only needed to report the total number of samples distributed to each physician to be PDMA compliant. Today, reps must explain their rationales for distributing 50 samples to one physician and 300 to another.

To support such reasoning, reps must demonstrate, for example, that they did not encourage off-label use by providing samples to a specialized physician with a patient population unlikely to need the medication. The rep must also prove that he or she did not offer an excessive number of samples for use with non-insured patients. The government could also ask to see reps' call notes to determine if telltale language involving agreements, arrangements, deals, understandings or trial use was used to describe a sales call.

Formal OIG training should be part of the standard sales training model. To foster compliance, managers might coach reps on how to speak with physicians when they discuss sampling practices. Role-play scenarios can help reps see when a sample might be regarded as an inducement. Managers should also coach reps on completing call notes using appropriate language.

HIPAA There was a time not too long ago when physicians took sales calls at the nurse's station. Sales reps hung around while nurses and patients received instructions, while pharmacy calls were placed, or even when the doctor wrote up patient notes. Physicians and reps discussed the benefits of a product for specific patients, citing details of the actual patient's case. Reps placed reminder stickers and educational material directly into patient files. Nurses would even provide lists of expectant mothers to infant-products reps, so they could send out coupons. Today, all of these practices would be considered HIPAA violations.