Milgram
TRENTON, N.J. (Legal Newsline) - A Division of Consumer Affairs report released by New Jersey Attorney General Anne Milgram has recommended new regulations meant to curtail the potential for conflicts of interest between doctors and pharmaceutical companies and medical device manufacturers.
The report addresses the impact potential conflicts have on patient care and sets forth new policies to be considered by the Board of Medical Examiners, the Board of Pharmacy, the Department of Health and Senior Services and academic medical centers.
The proposed regulations, which would serve as a complement to existing voluntary industry codes, would ban doctors from accepting gifts, fees or travel expense reimbursements from any pharmaceutical or medical device manufacturers. Doctors would be allowed to accept items that could offer patients a direct benefit, such as prescription samples or anatomical models to be used in a doctor's office.
The reforms would also bar physicians from accepting free food and meals in office settings or at promotional dinners. The regulations would ban all food except at accredited continuing medical education events where the fair market value of modest meals would be paid by the physicians.
The voluntary codes of ethics currently employed by the Pharmaceutical Research and Manufacturers of America and the Advanced Medical Technology Association prohibit member companies from providing entertainment, vacations or meals to physicians unless the meals are modest and at a medical office or in a clinical setting.
Other recommended regulations in the report would require doctors serving as consultants to pharmaceutical companies or medical device manufacturers to disclose publicly every two years any acceptance of more than $200 in consulting fees, honoria or funding for research or education.
"The proposed regulations accompanying the report on physician compensation are designed to ensure that patient care is guided by the unbiased exercise of doctors' best judgments," Milgram said.
"It is critical to minimize the potential for conflicts and it is critical that patients are made aware of any financial relationship between a physician and a pharmaceutical company or medical device manufacturer. Such relationships could bias medical decision-making."
Tight controls on data mining - the tracking of a physician's prescription information - are also recommended by the report, which would require that all physicians be notified when renewing their licenses that they can opt out of having their prescription information sold to health care information organizations by pharmacists. That information is used to steer pharmaceutical company marketing.
The Board of Pharmacy's regulations should be amended to require pharmacies to maintain documentation about doctors consenting to the sale of their prescribing information, the report says, while also recommending legislation to restrict the use and sale of prescriber information for commercial purposes.
The Board of Medical Examiners and the Board of Pharmacy have been asked to review the report and initiate a rule-making process. The New Jersey Register would then publish any regulations the boards propose to allow a full opportunity for comment. Finalized regulations would await consideration of those comments, which is expected to take at least six months.