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No such thing as a free lunch in Jersey
TRENTON, N.J.—A report recently released by New Jersey Attorney General Anne Milgram recommends a raft of new regulations to curtail the potential for conflicts of interest between doctors and pharmaceutical companies and medical device manufacturers. The report has resulted in statements of renewed commitments to transparent doctor-industry relationships from pharmaceutical industry members and trade groups.
The document, authored by the Attorney General's Division of Consumer Affairs, addresses the nature of the relationship between doctors, drug companies and device manufacturers who sometimes invest significant portions of their marketing budgets to influence the hand that holds the prescription pad. The proposed regulations impact the New Jersey Board of Medical Examiners, the Board of Pharmacy, the Department of Health and Senior Services and academic medical centers.
The 33,000 doctors who practice medicine in the state of New Jersey would be bound by these new regulations, if approved, since the Board of Medical Examiners oversees medical licensees in that state. Also, approval by the Board of Pharmacy would change the way that pharmacists would be permitted to provide medication prescribing information back to pharmaceutical companies.
Serving as a complement to voluntary industry codes, proposed regulations would ban doctors from accepting any gifts or fees or travel expense reimbursement from any pharmaceutical or medical device manufacturers. Also, the report suggests expressly forbidding a licensee from accepting any payment or subsidy to support attendance at an accredited continuing medical education program. These regulations would prohibit fees or travel expense reimbursement for attending company-sponsored meetings unless a doctor appears as a paid consultant or as a teacher at the meeting. Doctors attending unaccredited promotional educational sessions sponsored by pharmaceutical companies and medical device manufacturers should pay for their own meals.
In addition, the proposed reforms bar physicians and in some cases their office staff from accepting free food and meals in office settings or at promotional dinners.
Free samples provided to medical offices, though, will still be permitted. The report states that free samples provided to doctors, a critical component of pharmaceutical company marketing, are seen as beneficial and economical for patients, and should continue to be provided.
According to David Wald, a spokesman for Milgram's office, the key to these proposed rules is protection of the patient.
"The recommendations are made so that patients can have the confidence that doctors are providing care in the patient's best interest, and aren't being wined and dined," he says.
Disclosures of various relationships involved in the provision of patient care, Wald says, are key to insuring transparency.
Recommended regulations would also require doctors who serve as consultants to pharmaceutical companies or medical device manufacturers to publicly disclose every two years the acceptance of more than $200 in consulting fees, or honoraria, or funding for research or education. The report also recommends that the Board of Medical Examiners create a searchable database to make physician-disclosed information available to the public. It is also suggested that legislation requiring manufacturers to disclose payments to physicians be considered by state lawmakers.
The report recommends tight controls on what is known in the pharmaceutical industry as "data mining," or tracking which medications individual physicians prescribe.
Under the new recommendations, all physicians would have to be notified when renewing their licenses that they can opt out of having their prescribing histories sold by pharmacists to healthcare information organizations, which collect information on prescriptions for pharmaceutical company marketing.
In addition, the report recommends that the Board of Pharmacy amend its regulations to require pharmacies to maintain documentation that doctors have consented to the sale of their prescribing information.
"This provision," says Wald, "is part of the recommendations because it would require that pharmacies ask doctors proactively if it is okay for the pharmacy to provide the doctor's prescribing information back to the drug companies. The drug companies value this information to tell them which doctors are prescribing their products, or which doctors may need additional attention from company representatives."
Staff from the Division of Consumer Affairs met with physicians, pharmacists, hospital executives and pharmaceutical industry and insurance company representatives to gather input while compiling the report. A public hearing on the matter was conducted earlier last year.
Several states, including Vermont, Maine, Massachusetts, Minnesota and West Virginia, have imposed disclosure obligations on the pharmaceutical industry.
When contacted for comment, New Jersey-based Merck deferred to the HealthCare Industry Association of New Jersey, which forwarded a prepared statement saying in part: "Informative, ethical and professional relationships between healthcare providers and biopharmaceutical and medical technology companies are instrumental to effective patient care. We take this responsibility seriously and are constantly reexamining ways we can enhance essential company-physician interactions to reinforce the integrity of information about our medicines and products.
"We are also committed to the premise that our interactions with healthcare professionals not be perceived as inappropriate by patients or the public at large," the association adds.
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Advanced Medical Technology Association have adopted voluntary codes of ethics that 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. The proposed New Jersey regulations would go beyond the industry codes, banning all food except at accredited continuing medical education events where physicians must pay the fair market value of modest meals provided.
PhRMA forwarded a media release to Drug Discovery News, issued days after the publication queried the group on the New Jersey report. The release, issued Dec. 17, says in part that the group agrees with the statement issued by the HealthCare Institute of New Jersey, and makes reference to its own recently strengthened PhRMA Code on Interactions with Healthcare Professionals.
The report also makes recommendations concerning continuing medical education courses, physicians-in-training, physician accountability, academic detailing and potential conflicts in healthcare facilities.
The Board of Medical Examiners and the Board of Pharmacy are reviewing the report and are asked to initiate a rule-making process. Any regulations the boards decide to propose would then be published in the New Jersey Register, allowing for a public comment period before finalization of the regulations, a process that would be likely to take at least six months.