Maine has drawn several lines in the sand with the drug companies that do business here, but a proposed new state law would subject them to even greater scrutiny.

Supporters of the bill say the industry needs to know the state is paying attention and has an interest in the way drugs are marketed here. But the manufacturers oppose the measure, calling it an unnecessary burden that will only serve to drive up health costs.

Drug companies already face challenges in Maine. Manufacturers that want their products included on the state’s list of preferred drugs for Medicaid now must offer substantial discounts to Maine’s other low-income prescription programs, Maine Rx Plus and Low-Cost Drugs for the Elderly and Disabled. Also, under the terms of a law passed last year, drug companies must disclose how much money they spend marketing their products here through television, radio and print advertising.

Under the latest proposal, the state would establish a registry of drug company sales representatives who visit Maine’s doctors, hospitals and clinics to promote medications and other products. To qualify for the registry, the sales representatives, also known as “detailers,” would have to be licensed by the state. Licensing would require a minimum of a bachelor’s degree in pharmacy or in one of the chemical, physical or biological sciences and at least 10 hours of professional education a year.

The bill’s sponsor, Sen. Arthur Mayo, D-Bath, says drug companies exert a powerful influence over doctors’ prescribing habits.

“They push the products their companies are trying to sell,” Mayo said. “But in many cases an older, less expensive drug, or a generic formula may be just as effective or more effective.” By encouraging patients to request and doctors to prescribe expensive new drugs, the drug industry drives up patients’ bills, often with no measurable improvement in health, Mayo said. Higher patient bills result in higher insurance premiums for all Mainers, and higher premiums mean fewer people can afford insurance.

According to Mayo, a registry would help state health policy-makers understand how many detailers are pushing drug company products and how their presence here affects prescribing practices and the overall cost of health care. “It’s a start on the process,” he said.

No other state now requires detailers to be licensed and registered, although similar proposals are under consideration in West Virginia and Pennsylvania.

There’s no question that drug companies spend a lot of money promoting their newest and most lucrative products, and in most cases it pays off handsomely for them. For example, during the five years between the time the anti-inflammatory drug Vioxx came on the market and its withdrawal last fall – when it was determined to cause heart attacks and strokes – the manufacturer Merck was spending an average of $100 million a year on marketing the drug. This outlay was rewarded with annual Vioxx sales in the United States of about $1 billion, according to an analysis in the October 2004 issue of the New England Journal of Medicine.

Though many physicians reportedly questioned whether Vioxx was more effective for most patients than other, less expensive anti-inflammatories – including over-the-counter products such as Advil – many said they felt pressured to prescribe the product to patients who requested it after seeing it advertised.

Drug companies also market their products directly to physicians through detailers. Though federal regulations now prohibit sales representatives from offering the over-the-top gifts and incentives they used a decade ago to garner physician interest, persuasive presentations and generous supplies of free samples still can push doctors into prescribing medications they otherwise might not use.

According to Dr. Dan Meyer, a medical sociologist and director of research at the Maine Dartmouth Family Planning Residency Program at MaineGeneral Health in Augusta, “You can start your [low-income] patient on samples, and, if they work, you’ll usually write a prescription for that drug instead of a lower-cost generic or two medications that together equal the effect of the sample.

“Drug company representatives are not allowed on the premises of the Maine Dartmouth family practice,” Meyer added. As Maine physicians join their colleagues nationwide in practicing “evidence-based” medicine, he said, they should not be pressured to prescribe expensive, unproven new products such as Vioxx.

But Mayo’s proposal is drawing protest from the drug industry. The Pharmaceutical Research and Manufacturers of America will oppose the idea of a registry when the bill comes up for a public hearing at the end of March.

In a written draft of the organization’s comments, PhRMA says the measure is unnecessary. Company representatives are already highly educated and trained to be experts on the particular products they’re promoting, the organization says. Additionally, PhRMA claims, detailers may use only marketing materials that have been approved by the federal Food and Drug Administration and “must refer all requests for additional information to company scientists.”

Complying with a new set of state regulations would increase drug companies’ administrative costs, PhRMA says, and “not increase access for patients, improve overall health care quality, or reduce overall health care costs.”