Life Science Compliance Update

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June 14, 2017

Maine and Missouri Propose Legislation Restricting Industry and Physician Interactions

Legislation-510x244

As we are all aware, many states have started to take notice of the heat industry is under for its interactions with physicians. In order to “jump on the bandwagon,” many states have started to introduce legislation to place restrictions on such interactions, believing that the legislation will bring down drug prices. Two of the latest states to join this trend are Missouri and Maine.

Missouri

State Representative Rick Brattin of Missouri introduced House Bill 1021 during the 1st Regular Session of the 99th General Assembly. Representative Brattin introduced the measure in February 2017, which was then referred to the Committee on Health and Mental Health Policy. The last action taken was April 26, 2017, when a public hearing was scheduled, but the bill was not heard.

The bill proposed that it become unlawful for any drug (not device) manufacturer or distributor to offer or give any gift of value to a practitioner. Excluded from that basic requirement are the following: samples of a drug for free distribution to patients; items with a total combined retail value of more than $50 in any calendar year; publications and educational materials; sponsoring a medical conference, professional meeting, or other educational program, as long as the payment is not made directly to a practitioner and is used solely for bona fide educational purposes; and compensation for substantial professional or consulting services of a practitioner in connection with a genuine research project; among others.

Maine

In Maine, state representative Scott Hamann introduced legislation that would curtail gifts, free food, and speaking/consulting payments from drug companies to Maine physicians. Representative Hamann said he got the idea from a December 25, 2016, article in a local paper that detailed increased spending by pharmaceutical companies to promote opioids in Maine despite the ongoing attempts by the medical community to persuade physicians to cut back on prescribing opioids.

The language of the bill is largely based on ethics legislation in Minnesota, which has been in effect since 2005. The Minnesota law makes it illegal for doctors to receive more than $50 in gifts (including food) per year, as well as mandating that consulting and speaking fees be “reasonable” and for “bona fide” educational purposes. 

Interestingly, several medical centers in Maine have already made the decision for their doctors how much interaction with pharmacy they can have. For example, drug company representatives are not permitted in the door at Penobscot Community Health Care, and some health organizations – such as Maine Medical Center in Portland, Eastern Maine Medical Center in Bangor and Maine General Medical Center in Augusta – have strict policies limiting or banning such sales representatives from doctor’s offices.

Gordon Smith, executive vice president of the Maine Medical Association, which represents doctors before the Legislature, said he is “conflicted” about the idea and would need to see the details of the bill before taking a position.

Smith said accepting more than a “modest” gift is against the medical association’s code of ethics. He said if all doctors followed the guidelines spelled out in the ethics code, this wouldn’t be an issue. He believes that the central question is whether there is a need for a law to make such practices illegal, or whether current policies and guidelines are sufficient.

Dr. Douglas Jorgensen of Manchester, Maine received $42,522 from August 2013 through December 2015 from drug companies. Jorgensen was criticized by several colleagues for receiving the payments, saying they represented a conflict.

Jorgensen, in a letter to the Portland Press Herald four days after the story was published, defended the drug company payments, stating that, “My utilization of pharmaceutical companies for information … is no different than a computer software developer interacting with Microsoft or an oncologist seeking updates on chemotherapy from a pharmaceutical company,” Jorgensen wrote. “Medical experts, like non-medical experts, always seek competent and reliable sources of knowledge and information.”

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