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Are FDA and DEA officials watching you?
Sam walks into Dr. Trump's office with a killer call plan in mind. He has a relatively new product to detail and, after weeks of coaching and preparation, Sam is ready to dazzle the physician.
When he arrives, however, Rita (Dr. Trump's somewhat aloof office nurse) informs him that Dr. Trump is especially busy and cannot see him. She also informs Sam that the office is so busy today that she cannot allow him beyond the front desk. The one thing he can do, she tells him, is give her his samples for the sample closet. Rita will secure Dr. Trump's signature for the samples while Sam waits in the lobby.
Sam doesn't know what to do. His company and his peers in the field have always emphasized the importance of personally witnessing a physician's signature for pharmaceutical samples. Some sales reps have even insisted that it is a federal regulation that he witness Dr. Trump's signature for the samples. Rita, however, does not look as though she is going to bend, and he really wants to be sure Dr. Trump has the samples.
Sam decides to do as Rita asks, and hands her the samples and signature form. She disappears behind the front office and quickly returns with the form, which appears to have been signed by Dr. Trump. Although Sam feels uneasy about the decision he made, he thanks Rita and leaves to make his next call.
Did Sam do the right thing?
"It's the proverbial 'Wait here and I'll get the physician's signature' line, and then the nurse goes around the corner and signs it," said one company's director of sales training and development. "If the doctor put an order in and signed the request form at that time, then the rep already has the signature, but if the rep is soliciting - 'Would you like some of this product, or some of that product?' - then he or she need to have the doctor sign on the spot."
However, according to Crystal Wyand, a public affairs specialist with the FDA's Center for Drug Evaluation and Research, there is no federal regulation requiring pharmaceutical sales reps to witness a physician's signatures for prescription medicines, according to Crystal Wyand, a public affairs specialist with the agency's Center for Drug Evaluation and Research.
"All that is required is a legitimate signature," Wyand said after consulting with one of the agency's consumer safety officers and a senior regulatory expert for the Prescription Drug and Marketing Act, commonly known as PDAMA.
"Usually the secretary, receptionist or nurse is aware of what the physician needs when the sales reps come around," she said. "That staff person can carry [the form] back to the physician and get the signature. Since doctors aren't always available in the front of the office, it's not always possible for a pharmaceutical rep to witness the doctor's signature."
But what about the nurse who doesn't want to interrupt a busy physician and so ducks around a partition wall to sign the form? Is this is a legitimate signature? According to Wyand and the senior regulatory officer, it is.
While it is illegal for anyone - including medical office staff - to divert medicines from reaching their intended destination and user, it is not illegal for legitimate office personnel to sign for the receipt of requested medicines.
If the product was a controlled substance, however, the scenario would be different. The Drug Enforcement Agency has different regulations for the delivery of drug samples than the FDA does. One of those regulations is that sales reps must personally witness physicians' signatures for controlled substances. Another is that sales reps keep close track of every sample.
"The DEA doesn't allow for human errors," explained Russ Prestipino, senior manager of sample accountability at Parke-Davis. "There can't be any discrepancy in the number of controlled substances samples [a rep reports delivered.]"
Confusion about the roles and regulations of the two agencies gave rise to a firestorm of rumors among pharmaceutical sales reps during 1998.
Sales reps whispered about reported FDA and DEA "stings," in which federal agents lurked in physician's offices and waited for unsuspecting sales reps to do what Sam did. There were other rumors of arrests in Michigan and nurses illegally diverting Viagra samples. According to the FDA and several industry sources, none of the rumors are true.
Sample delivery is controlled by both the FDA and the DEA, and both agencies have criminal investigation offices which investigate suspicious incidents. But the FDA entrusts pharmaceutical companies to have a verification system and a sample audit security system to ensure that fraud is nonexistent, or at least kept to a minimum, and the DEA is only concerned with controlled substances. Federal sting operations in physician offices are myths.
Many pharmaceutical companies have taken a stance on the delivery of samples that is even stricter than that of the FDA. In order to avoid confusion on the part of reps and doctors alike and improve accountability, some companies have made it mandatory company policy that sales reps witness every physician's signature.
One company began requiring this practice just two months ago, while others have had the practice in place for nearly a year. Companies that deliver controlled substances strictly enforce the rule, as do several that don't deliver controlled substances. Some companies provide their sales reps with sample call documents that cite PDAMA as the reason why reps must witness physician signatures. Other companies leave it to their reps to deflect complaints from irritated office personnel and physicians who don't want someone watching over their shoulder as physicians sign for samples.
Where does this leave Sam, and other reps who find themselves in similar situations on a daily or weekly basis?
Many find themselves torn between wanting to follow their companies' policies and not wanting to deprive their customers of needed samples. In addition, they also find themselves in the uncomfortable position of having to play hard ball with physicians and nurses - the very people with whom they are trying to build an easy, comfortable relationship.
"If the doctor is too busy to see you, what do you do?" complained one experienced sales rep. "Do you wait to see him next time? It's almost your duty to leave the samples because he needs them. I know what I risk losing [if I fail to witness the signature]," the sales rep continued, "but it backs me into a corner because I need to leave the samples."
Some reps find ways to work around the dilemma.
"If the doctor is too busy, I try to schedule lunch when he and the staff have more time," said one rep whose company explicitly demands that reps witness all physician signatures.
Given the example of Sam, she reacted by saying: "I don't think [he] acted in the best interest of the company, the physician or the patients, especially if it was a relatively new product. It's inappropriate to leave samples without informing the doctors about uses."
Given the complicated and sometimes conflicting nature of what is required of sales reps in terms of sample delivery, reps are best advised to follow the guidelines established by their individual pharmaceutical companies. Companies consult with their legal departments before establishing protocol regarding sample delivery, and these experts are the people who will defend sales reps if they are investigated for following the company policy.
When faced with situations such as the one Sam encountered, reps might try exercising creativity and selling skills to find ways to get in front of the physician. They might also practice humorous and tactful ways to extract themselves from the situation - ways that don't suggest to the office nurse that the rep doesn't trust him or her not to forge the physician's signature.
If reps adhere to company policy and use a little imagination, they won't have to worry about either job security or unfounded rumors about phantom federal agents. PR