Monday, March 11, 2019

New Jersey's 45J: regulating acceptance of compensation to prescribers by drug companies

The purpose of New Jersey's administrative rule 45J:

The rules in this chapter regulate the receipt and acceptance by prescribers of anything
of value from pharmaceutical manufacturers to ensure that such relationships do not
interfere with prescribers' independent professional judgment.

Some relevant definitions:

"Prescriber" means a physician, podiatrist, physician assistant, advanced practice
nurse, dentist, or optometrist licensed pursuant to Title 45 of the Revised Statutes.
"Prescriber" does not include a licensee who is an employee, as defined in N.J.A.C.
18:35-7.1, of a pharmaceutical manufacturer who does not provide patient care.

"Promotional activity" means any unaccredited activity, meeting, or program organized
or sponsored by a pharmaceutical manufacturer, or the manufacturer's agent, that is
directed at prescribers to promote the prescription, recommendation, supply,
administration, use, or consumption of the manufacturer's products through any media
or medium. “Promotional activity” does not include an education event or services
provided in connection with research activities.” [bolding added]

"Education event" means an education event, third-party scientific or educational
conference, professional meeting or workshop, seminar, U.S. Food and Drug
Administration required education and training, or any other gathering, held in a venue
that is appropriate and conducive to informational communication and training about
healthcare information, where:
1. The gathering is primarily dedicated, in both time and effort, to promoting
objective scientific and educational activities and discourse (one or more
educational presentation(s) should be the highlight of the gathering); and

2. The main purpose for bringing attendees together is to further their knowledge
on the topic(s) being presented.

13:45J-1.6 Bona fide services cap

A prescriber shall not accept more than $ 10,000 in the aggregate from all
pharmaceutical manufacturers in any calendar year for the bona fide services of
presentations as speakers at promotional activities, participation on advisory boards,
and consulting arrangements. Payments for speaking at education events are not
subject to this cap
, but must be for fair market value and set forth in a written
agreement. Payments for research activities and, consistent with NJ.A.C. 13:45J1.4(a)10,
payments for royalties and licensing fees are not subject to this cap.

Text on NJ radio's 101.5 website states:

On the same day Chris Christie ends his rein as the Governor of New Jersey,
the state welcomes new rules — crafted by his administration — that aim to put a dent
in what's considered one of the leading causes of the deadly opioid crisis.

Proposed in August, the rules that take effect Tuesday impose limits on payments
and other compensation that licensed prescribers in New Jersey may accept from pharmaceutical companies.

Among the highlights:

Licensed physicians, physician assistants, dentists and other prescribers may not accept
more than $10,000 per year (total from all manufacturers) for services such as speaking engagements,
participation on advisory boards and consulting arrangements. Contracts entered before Tuesday do not apply.
The new cap does not apply to payments related to research and education events.
Meals provided by manufacturers to prescribers may not exceed a value of $15. The original proposal imposed
a cap on the number of meals at four per year, per manufacturer, but that was removed following public comment.
Prescribers are prohibited from accepting gifts such as cash, gift cards, entertainment and items
with a manufacturer's logo — anything that would benefit the prescriber or staff.
According to Christie's office, New Jersey doctors collected $69 million from drug companies
and device manufactures in 2016. Two-thirds of the cash was received by just 300 physicians,
with nearly 40 bringing in at least $200,000.


The rules hold the prescribers accountable for staying within the limits, not the pharmaceutical companies,
making New Jersey unique when compared to other states with caps in place.

"I think that anything that eliminates the appearance of a conflict, or the appearance that doctors are prescribing
opioids for the wrong reason, is certainly a step in the right direction," Angelo Valente, executive director
of the Partnership for a Drug-Free New Jersey, told New Jersey 101.5.


A 2007 article in the New York Times brought out an issue in compensating doctors for giving
talks TO third parties:

Those delivering the talks get training that involves learning drug makers’ most important marketing messages.
And they receive anywhere from $500 to $5,000 for each talk they give, with some doctors earning more than $100,000 annually.

“This is the companies’ way of thanking high prescribers,” said David J. Rothman,
president of the Institute on Medicine as a Profession at Columbia University.
“Drug companies don’t really care who’s in the audience.”

When asked whether drug makers’ motivation for hiring doctors to educate secretaries
may be to influence them instead of the secretaries, many doctors said they had never thought of that.

“That’s a good question,” answered Dr. Kent G. Brockmann, a psychiatrist from the Twin Cities,
who earned more than $16,000 from 2003 to 2005 doing educational talks for drug makers.
“Maybe they’re trying to keep me loyal to those drugs.”



The unintended consequences reported on are not a surprise. As an initial response,
many of our clients have avoided placing programs in New Jersey or with New Jersey prescribers
until their legal and compliance teams have finalized their internal policies explaining how to
follow the new law. Whether these organizations end up mirroring their own protocols in Vermont and Minnesota,
or take a more nuanced approach, will become evident as the industry works quickly to adapt to the new law.
In the meantime, the law, which has had some disruptive elements, does deserve industry attention; and with
collaboration, communication, and attention to detail, compliance is achievable.

One notes that the details of 45J are in the form of a regulation, not as a statute passed through
the legislature. Note text from

State Sen. Joseph Vitale, D-Middlesex, said the proposal was a step in the right direction, but said $10,000 was still too high. “$10,000 is still a lot of money,” Vitale said. “Why not limit it to $100 or $200?”

However, Vitale noted that he would like to see the proposal pass through the legislature for debate – something that many in Christie’s political party harped on about the Obama Administration’s implementation of the Affordable Care Act. As we have seen time and time again, many politicians can argue either side of the coin, depending on who is in charge.

Public Hearing

The new regulation which was submitted last week to the Office of Administrative law and will be published on October 2, 2017, in the New Jersey Register must undergo a public hearing before it is implemented, but that doesn’t necessarily mean that changes will be made. The public hearing is expected to be held on October 19, 2017, in the Monmouth Room at the Division of Consumer Affairs in Newark.


**There has been some discussion of the impact of 45J on patient educational programs in the area
of multiple sclerosis (MS).


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