TRENTON, N.J.—A report recently released by New JerseyAttorney General Anne Milgram recommends a raft of new regulations to curtailthe potential for conflicts of interest between doctors and pharmaceuticalcompanies and medical device manufacturers. The report has resulted instatements of renewed commitments to transparent doctor-industry relationshipsfrom pharmaceutical industry members and trade groups.
The document, authored by the Attorney General's Division ofConsumer Affairs, addresses the nature of the relationship between doctors,drug companies and device manufacturers who sometimes invest significantportions of their marketing budgets to influence the hand that holds theprescription pad. The proposed regulations impact the New Jersey Board ofMedical Examiners, the Board of Pharmacy, the Department of Health and SeniorServices and academic medical centers.
The 33,000 doctors who practice medicine in the state of NewJersey would be bound by these new regulations, if approved, since the Board ofMedical Examiners oversees medical licensees in that state. Also, approval bythe Board of Pharmacy would change the way that pharmacists would be permittedto 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 ortravel expense reimbursement from any pharmaceutical or medical devicemanufacturers. Also, the report suggests expressly forbidding a licensee fromaccepting any payment or subsidy to support attendance at an accreditedcontinuing medical education program. These regulations would prohibit fees ortravel expense reimbursement for attending company-sponsored meetings unless adoctor appears as a paid consultant or as a teacher at the meeting. Doctorsattending unaccredited promotional educational sessions sponsored bypharmaceutical companies and medical device manufacturers should pay for theirown meals.
In addition, the proposed reforms bar physicians and in somecases their office staff from accepting free food and meals in office settingsor at promotional dinners.
Free samples provided to medical offices, though, will stillbe permitted. The report states that free samples provided to doctors, acritical component of pharmaceutical company marketing, are seen as beneficialand 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 theconfidence that doctors are providing care in the patient's best interest, andaren't being wined and dined," he says.
Disclosures of various relationships involved in theprovision of patient care, Wald says, are key to insuring transparency.
Recommended regulations would also require doctors who serveas consultants to pharmaceutical companies or medical device manufacturers topublicly disclose every two years the acceptance of more than $200 inconsulting fees, or honoraria, or funding for research or education. The reportalso recommends that the Board of Medical Examiners create a searchabledatabase to make physician-disclosed information available to the public. It isalso suggested that legislation requiring manufacturers to disclose payments tophysicians be considered by state lawmakers.
The report recommends tight controls on what is known in thepharmaceutical industry as "data mining," or tracking which medicationsindividual physicians prescribe.
Under the new recommendations, all physicianswould have to be notified when renewing their licenses that they can opt out ofhaving their prescribing histories sold by pharmacists to healthcareinformation organizations, which collect information on prescriptions forpharmaceutical company marketing.
In addition, the report recommends that the Board ofPharmacy amend its regulations to require pharmacies to maintain documentationthat doctors have consented to the sale of their prescribing information.
"This provision," says Wald, "is part of the recommendationsbecause it would require that pharmacies ask doctors proactively if it is okayfor the pharmacy to provide the doctor's prescribing information back to thedrug companies. The drug companies value this information to tell them whichdoctors are prescribing their products, or which doctors may need additionalattention from company representatives."
Staff from the Division of Consumer Affairs met withphysicians, pharmacists, hospital executives and pharmaceutical industry andinsurance company representatives to gather input while compiling the report. Apublic hearing on the matter was conducted earlier last year.
Several states, including Vermont, Maine, Massachusetts,Minnesota and West Virginia, have imposed disclosure obligations on thepharmaceutical industry.
When contacted for comment, New Jersey-based Merck deferredto the HealthCare Industry Association of New Jersey, which forwarded aprepared statement saying in part: "Informative, ethical and professionalrelationships between healthcare providers and biopharmaceutical and medicaltechnology companies are instrumental to effective patient care. We take thisresponsibility seriously and are constantly reexamining ways we can enhanceessential company-physician interactions to reinforce the integrity ofinformation about our medicines and products.
"We are also committed to the premise that our interactionswith healthcare professionals not be perceived as inappropriate by patients orthe public at large," the association adds.
The Pharmaceutical Research and Manufacturers of America(PhRMA) and the Advanced Medical Technology Association have adopted voluntarycodes of ethics that prohibit member companies from providing entertainment,vacations or meals to physicians, unless the meals are modest and at a medicaloffice or in a clinical setting. The proposed New Jersey regulations would gobeyond the industry codes, banning all food except at accredited continuingmedical education events where physicians must pay the fair market value ofmodest meals provided.
PhRMA forwarded a media release to Drug Discovery News, issued days after the publication queried the groupon the New Jersey report. The release, issued Dec. 17, says in part that thegroup agrees with the statement issued by the HealthCare Institute of New Jersey,and makes reference to its own recently strengthened PhRMA Code on Interactionswith Healthcare Professionals.
The report also makes recommendations concerning continuingmedical 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 arereviewing the report and are asked to initiate a rule-making process. Anyregulations the boards decide to propose would then be published in the NewJersey Register, allowing for a public comment period before finalization ofthe regulations, a process that would be likely to take at least six months.