Industry Pushes Back as NJ Tries to Crack Down on Crooked Doctors
A public hearing was held in Newark on the state's proposed rules to prohibit prescribers from accepting lavish meals and uncapped compensation for consulting work, speaking engagements and other services from drug companies.
Gov. Chris Christie announced the proposals at the end of August as part of a plan to slow the prescription painkiller abuse epidemic.
The governor pointed out New Jersey doctors collected $69 million from drug companies and device manufacturers in 2016. Two-thirds of that $69 million went to just 300 doctors.
According to the governor’s office, the proposed rule changes would strengthen and clarity existing standards and limitations already in place by:
• Prohibiting cash, gift cards, entertainment and recreational items, items for prescriber’s personal use, payments supporting non-faculty attendance at promotional activities, and continuing education events;
• Exempting certain items if their purpose is for the benefit of patients or prescriber education, such as educational materials;
• Setting standards for agreements by which prescribers are paid for bona fide services such as speaking at promotional activities and education events, and participating in advisory bodies;
• Requiring the terms of consultant agreements to be in writing;
• Allowing for “modest” meals that can be provided in different settings for learning no more than four times a year, not to exceed $15 per provider;
• Capping compensations for bona fide services (with the exception of speaking at continuing-education events) from all manufacturers at $10,000 every year.
During the hearing, State Attorney General Christopher Porrino said the proposed rule changes are not about vilifying the medical profession or the pharmaceutical industry.
“We believe that the vast, vast number of prescribers in New Jersey strive to make the best treatment decisions that they can on behalf of their patients every day, but there are exceptions, and those few have hurt many, many people,” he said.
Porrino pointed out “pharmaceutical company marketing practices, paying for consulting arrangements, speaking engagements and food and beverage and travel are all appropriately being scrutinized.”
“There remains widespread concern that the treatment decisions of some prescribers can be and are being influenced by these payments, rather than by what is in the best interest of their patients.”
Investigators from the Attorney General’s Office began looking into this issue more than a year ago.
“We don’t usually announce the onset of an investigation, but here we did, because we were so concerned about the danger to the public,” Porrino said.
He noted a pain management practitioner in Phillipsburg, Dr. Kenneth Sun, has been charged with accepting more than $136,000 from the drug maker Insys Therapeutic while indiscriminately prescribing the powerful fentanyl painkiller Subsys to patients who did not meet the federal criteria for receiving it.
He said the state is seeking penalties and license revocation or suspension.
“I want everybody to know that our investigations into these matters and to matters like them are ongoing,” he said. “What we’re seeing as part of our work is troubling, and I can assure you that there will be more cases against doctors and pharmaceutical companies.”
Porrino said the goal is to make sure drugs are used properly and that prescribing decisions are based on what is in the best interest of the patient.
Dozens of representatives from pharmaceutical, bio-tech and life sciences organizations and companies testified at the hearing about unintended problems with the proposed rule changes.
Kristina Moorhead, senior director of state advocacy at the Pharmaceutical and Researchers and Manufacturers of America, or PHARMA, said the proposed changes “contain too many unintended consequences that will impede health care education diminish opportunities and clinical trials and unintentionally exacerbate the opioid crisis.”
Debbie Hart, president and CEO of BioNJ, representing 400 companies, agreed.
She said it’s unclear how the proposed rule changes, while well-intentioned, will favorably impact the opioid crisis.
“It will have unintended consequences that may squelch the very innovation that have the potential to eliminate opioid addiction and other devastating diseases.”
She stressed the proposed change would actually cause more harm than good.
“It will restrict access to drugs in clinical trials for patients, and may inadvertently raise the cost of health care and impact the New Jersey economy in ways that we can ill afford,” she said.
Hart added it has the potential “to do irreparable harm to the bio-tech industry which we are desperately trying to grow.”
She noted that “pre-product companies still in the [research and development] stages, or those with only one product on the market, will not locate or remain in New Jersey because they simply cannot risk their company on the uncertainty that these regulations would create.”
Hart added: “Our companies depend upon interaction with physicians for clinical research, just as physicians utilize the education that they receive from our companies, without that interaction important advances will not happen.”
Porrino said all comments, objections, suggestions and proposals will be reviewed and a final rule change proposal should be completed by early December of this year.