New rules limiting physician interactions with pharmaceutical companies will go into effect in New Jersey on January 16.
Under the rules, contracts and payments entered into by physicians directly with the pharmaceutical industry will be capped at $10,000 a year. These agreements include speaker fees (except for those at continuing education events), participation on advisory boards, and consulting arrangements.
Also, meals would be capped at $15, and physicians are forbidden from accepting any gift if it does not advance care or education — pens, floral deliveries, gift certificates, etc.
Groups including the Medical Society of New Jersey protested the language in the original proposed rule, saying that, without a clear distinction, clinical trials could be swept into the relationships covered by the $10,000 limit.
New Jersey's Attorney General Christopher Porrino has since added clarification that clinical trials are exempted from the final rule.
The rule, "Limitations and Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescribers," appears to be the first of its kind to be tied to physician licensure and not directed at pharmaceutical companies.
Other states have versions of restrictions. For example, as of last October, Nevada has required sales representatives to file reports on free drug samples and payments to prescribers above $10. Effective last November, Maine law bans drug companies offering prescribers any cash gift or any gift "for which reciprocity is expected or implied. As reported in Medscape Medical News, the California Senate also passed limits on gifts last year.
Porrino noted in a press release that although the New Jersey rule is intended to help reduce the opioid epidemic, it is also meant to cover all prescriptions "so as to ensure that patient care is guided by the unbiased, best judgment of the treating prescriber."
Otto Sabando, DO, from the department of emergency medicine at St. Joseph's Healthcare System-Paterson, in Paterson, NJ, testified against the proposed rule in October on behalf of his professional association, the New Jersey Association of Osteopathic Physicians and Surgeons.
He told Medscape Medical News that these restrictions on physicians will not reduce the opioid crisis and will likely have the unintended effect of reducing physicians' opportunities to learn about new drugs. Momentum for the opioid epidemic was rooted not in financial incentives but in the culture of pain as the fifth vital sign, he said.
Meals and meetings outside of work are often the only time for physicians with packed schedules to learn about new drugs, he said. Taking away incentives for them to do so may lead to less informed decisions about what drugs to use, he added.
Porrino said in a news release announcing the original rule, "The rule will prohibit doctors from forming unsavory financial relationships with drug companies that manufacture highly addictive opioids. It also gives our professional boards enforceable standards to hold doctors accountable if they violate that rule."
However, Dr Sabando days, "There's no data stating that if they do enforce this new regulation that it will change doctors' prescribing habits of any medication. Show us the evidence. Tell us the numbers needed to treat. Tell us how or why this will make the patient better over time."
He noted that pharmaceutical companies have already moved to target patients directly with commercials urging consumers to ask their doctors about a drug.
He added that the urgency of the opioid epidemic probably helped push the rule through the attorney general's office in a regulatory process instead of getting debated in the legislature.
"This, to me, was politically motivated," Dr Sabando said.
Sign of Change
The New Jersey rule and other restrictions in other states may be a sign of a wave of change from the days of extravagant gifts and travel. But while change was necessary, the New Jersey rules go too far, Dr Sabando says.
The American Medical Association (AMA) has not taken a position on the New Jersey rule, but includes in its code of ethics these comments: "Relationships among physicians and professional medical organizations and pharmaceutical, biotechnology, and medical device companies help drive innovation in patient care and contribute to the economic well-being of the community to the ultimate benefit of patients and the public. However, an increasingly urgent challenge for both medicine and industry is to devise ways to preserve strong, productive collaborations at the same time that they take clear effective action to prevent relationships that damage public trust and tarnish the reputation of both parties."
The AMA code also says physicians should decline cash gifts in any amount from any entity that could benefit from physicians' treatment recommendations or any gift for which reciprocity is expected.
Dr Sabando declared no relevant financial relationships.
Medscape Medical News © 2018
Cite this: New Jersey Rule Limits Physician-Pharma Interactions - Medscape - Jan 12, 2018.