Group seeks law requiring pharma reps to be licensed, regulated in West Virginia

West Virginia is among the states looking at ways to control drug costs. A West Virginia committee appointed to come up with ideas has suggested that the states pharmaceutical representatives are regulated and accountable by law for ethical marketing practices. Medzilla looks into what might be a trend in the U.S. and what this could mean for pharma sales reps.

Marysville, WA August 27, 2004 -- The State of West Virginia passed a law last year, which created a public body called the Pharmaceutical Cost Management Council, a group charged with delving into ways to reduce the price of patented pharmaceutical drugs in the state. Among the recommendations the panel is giving the legislature this September, is a proposal to require pharmaceutical representatives, like doctors, lawyers, hair dressers and other professions in the state, be regulated by West Virginia.

We thought it would be appropriate to get a sense of the number of drug reps operating in the state and what sort of ethical or conflict of interest standards they are operating under, says Kevin Outterson, associate professor of law at West Virginia University and a council member.

The foundation of the law would be that pharmaceutical representatives would be required to follow the now voluntary marketing guidelines developed by the Pharmaceutical Research and Manufacturers of America (PhRMA). The guidelines seek to eliminate questionable practices, such as buying elaborate dinners, entertainment tickets for more for doctors and other clients.

"Instead of some companies voluntarily complying and others only partially complying or ignoring the guidelines altogether, this would level the playing field," Outterson says. The thought would be that each pharmaceutical representative who has contact with prescribers would be subjected to a nominal registration process and would be expected to comply with the PhRMA guidelines on ethical marketing.

Pharma reps wouldnt have to take any tests or have minimal education requirements according to the recommendation as it stands now; rather, they would just have to play by the rules. In addition, there would be some sort of a process so that if a complaint were launched that someone violated one of the ethical requirements of the PhRMA code, the state would have the ability to discipline or suspend the registration of the person violating the rule.

According to Outterson, there are a number of states who are evaluating various forms of regulations on pharmaceutical marketing. But this precise example of just adopting the PhRMA code and making it mandatory--Im not aware of any other states that have completed that yet, he says.

John Law, spokesman for the West Virginia Department of Health and Human Resources, says the state government has not yet made a decision on whether it will support that part of the councils recommendations.

This is just something that was discussed conceptually along with other things, Law says. If there is legislation required, there may be a special session or it may be until January, which is our regular session. If there is anything that can be handled in a regulatory manner, that might come a lot more quickly. By next year, you will see some difference.

PhRMA objects to the proposed regulation of pharma reps, saying the fees for licensing are out of line and an unnecessary additional financial burden for companies that want to do business in West Virginia.

Wanda Moebius, spokeswoman for PhRMA, says that the associations voluntary guidelines are strict and strong enough to regulate the industry.

Our companies already adhere to the agreed upon guidelines. (The guidelines were) unanimously passed by our board, and our board is comprised of the CEOs of pharma companies. If your CEO has directed you to do something, I imagine that its in your best interests to do it, she says.

However, a pharmaceutical rep who works outside West Virginia for a major pharmaceutical firm, who did not want to reveal his name, says its not a bad idea to regulate reps.

Ive heard rumblings of (laws to regulate reps), and I guess its all part of getting back to the real reason why drugs are prescribed and not prescribing a drug because someone gives you a gift. I can understand that. Thats where the relationship comes in, the rep says. I think it would be beneficial if something like that happensnot to get too regulated--but some outside watchdog look over the pharmaceutical industry to make sure these regulations are happening.

Because drug costs are so out of control, moves like this by grassroots and other committees are becoming a trend, says Frank Heasley, PhD, president and CEO of MedZilla.com, (www.medzilla.com) a leading Internet recruitment and professional community that serves biotechnology, pharmaceuticals, healthcare and science. It makes sense that we have to do something, and we, too, have heard the rumblings that states want to get more of a handle on how drugs are marketed to doctors and others.

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