Physician Reporting Obligations: New Jersey’s Proposed Conflict of Interest Regulations Go a Step Further

December 15, 2009

By Carrie S. Martin

New Jersey’s Attorney General recently endorsed a report prepared by the Division of Consumer Affairs (the “Division”), recommending certain restrictions and obligations on physicians and industry to limit potential conflicts of interest.  Many of the recommendations are similar to those in the codes adopted by the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and the Advanced Medical Technology Association (“AdvaMed”), which prohibit manufacturers from providing entertainment, non-educational gifts, and lavish meals to physicians, among other things. 

They also include proposed manufacturer reporting requirements, which are already on the books in states like Minnesota, Vermont, and Massachusetts.  However, the New Jersey Division’s proposals go even farther:  not only do they propose to impose reporting obligations on pharmaceutical and device manufacturers, they recommend imposing obligations on physicians as well. 

Here, in brief, are some of the most salient proposals: 

  • The Division proposes to require physicians to disclose – as a condition of the biennial medical license renewal process – whether they have accepted more than $200 during the preceding two years from manufacturers, including money from consulting or research arrangements, honoraria, food, or any other economic benefit.  The Division further proposes that this information be made publicly available.

  • The Division proposes to ban physicians from accepting food from manufacturers in all venues, including in-office meals, except for modest meals provided at accredited continuing medical education (“CME”) events.  The CME meals, however, must be paid for by the CME provider, not paid directly by manufacturers.

  • The Division recommends that all physicians be notified of their ability to opt-out of data mining (i.e., to prevent companies from selling information about the physician’s prescribing habits).  In addition, the Division recommends that the State enact legislation to prohibit the use of information collected via data mining for commercial purposes.

The report also proposes to amend New Jersey regulations regarding gifts to physicians, CME requirements, physicians-in-training, physician accountability, health care facilities and academic detailing.

The relevant New Jersey agencies are now working on draft regulations in response to the Division’s recommendations.  If the Division and Attorney General get their way, New Jersey will have the most restrictive disclosure laws to date.

Categories: Drug Development