Free Flomax pen? That’ll be $5,000

By LILLIAN LING

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Looks like doctors won't be scoring free trips to the Bahamas anymore. Last week, the Massachusetts Public Health Council turned up the heat on pharmaceutical and medical device companies, demanding they show the goods; specifically, that they disclose their sales and marketing reports to the public, follow a marketing code of conduct and adhere to a strict compliance program.

Melissa Lopes, deputy general counsel of the Massachusetts Department of Public Health (DPH), brought the importance of having a tighter set of regulations to light when she cited research done by the Prescription Project, an advocacy group dedicated to advancing medical practice and policy. "Ninety-four percent of physicians nationally have received food/drug samples or other reimbursements and payments from the drug industry. Studies show that even small gifts may create an unconscious demand for reciprocity," she said. "Possible negative effects include reduced generic prescribing and increased overall prescription rates."

Council member Lucilia Prates Ramos noted the dangers of marketing-induced bias. "If I go into a doctor's office and I see a coffee mug with a pharmaceutical company's brand on the desk, I know he's more apt to prescribe that brand for me," she said.

The proposed regulations would take shape in three parts. A marketing code of conduct would outline which activities and materials are allowed. A compliance program would then ensure pharmaceutical or medical device manufacturing companies train employees on the code of conduct and investigate breaches or noncompliance, and would file an annual report for the DPH, describing any training or necessary investigation.

Lastly, a disclosure report would allow for transparency within the industry; Lopes said the regulations would ensure drug and device companies "report any fee, payment, subsidy or economic benefit with a value of at least $50 to any covered recipient in connection with the company's sales and marketing activities."

However, the language of the regulations sparked concerns. Council member Paul Lanzikos was curious about the geographic reach of these regulations, coming up with some inventive hypotheticals: "If a physician is going to be participating outside of the state of Massachusetts, say, on a yacht, would the regulations apply?" Since the physician is practicing for the state, Lopes replied affirmatively. Anyone who violates the regulations will be punished with a fine of not more than $5,000 for each offense—even if it takes place on a yacht off the Massachusetts shore.

Further discussion of pharmaceutical marketing conduct regulations will be open to the public in two hearings, one that will take place on January 9th at the Henry I. Bowditch Public Health Council Room [250 Washington St., Boston] at 9am, and one on January 12th at the UMass Medical School [55 Lake Ave. North, Worcester] at 1pm.

DPH Commissioner John Auerbach emphasized that "soliciting public comments is important to be able to understand the breadth of these regulations," but acknowledged the lax enforcement of the regulations, should they pass. "We experienced a $28 million budget cut," he said. "It would be a challenge to enforce regulation because of these realities." Though, if the regulations pass and enough physicians and companies are fined, they may just be able to gain back that budget deficit after all.