The regulation was proposed by the Christie administration in an effort to address the opioid crisis. As proposed, the regulation would set a cap of $10,000 per year on payments by biopharmaceutical companies to physicians for a range of services, including speaking at continuing education events and consulting on drug development.
Testifying on behalf of the Association of Clinical Research Organizations (ACRO), the organization’s Executive Director Doug Peddicord, Ph.D., noted that the $10,000 cap would apply also to clinical trial grants, which includes the costs of medical equipment and supplies, tests and laboratory services, patient compensation, as well as research staff salaries, among various other activities.
As drafted, Peddicord said the regulation “would make it impossible for New Jersey physicians to engage in the conduct of industry-sponsored clinical trials.”
“Clearly we think this was an inadvertent mistake,” he told Outsourcing-Pharma.com. “I think where New Jersey went awry was essentially imposing this cap on all physician services of all kinds.”
ACRO Chairman and President and CEO of Bioclinica, John Hubbard, Ph.D., said the proposed regulation “demonstrates a fundamental lack of understanding regarding the clinical trial process and the way clinical research investigators are compensated by the biopharmaceutical industry for conducting these regulated trials.”
“In the majority of cases, the cap proposed would virtually eliminate the ability of researchers and institutions to conduct biopharmaceutical sponsored clinical trials in the state of NJ,” Hubbard explained.
Peddicord and Hubbard said they have not seen a similar proposal before, but both told us they would not be surprised if others propose similar reforms.
“The fear is that others might see this as a good idea without fully understanding the potential impact,” added Hubbard.
Peddicord echoed these concerns and said he hopes future attempts at similar regulations will be more carefully drafted in order to “get at the potential for incentives that would relate to opioid prescribing.”
Clinical trial investment
In the state of New Jersey, industry and federal investments in clinical trials totaled more than $263m in 2013 and resulted in $779m in economic impact, according to a 2016 study by Bio NJ conducted by the Rutgers Schools of Business and Planning and Public Policy.
“I think it will require a much more targeted effort,” he explained.
“Again, while well intended, I fail to see how this action addresses the opioid crisis at its core, and there is clear collateral damage to innovation and the conduct of critical research,” added Hubbard. “I believe if this regulation moves forward, it will not achieve the desired goal and will stifle development of life-saving medicines and treatments in NJ.”
However, Peddicord’s personal opinion is that the clinical trials payments aspect of the regulation will be exempted from the payment cap – though nothing can be sure until the regulation is finalized, he said.
The decision on whether the proposed rule will be revised or withdrawn is expected before the end of the year.
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), and other stakeholders, also testified at the public hearing.
Refocusing on the opioid epidemic
Hubbard proposed that Governor Christie’s administration would benefit from a Blue Ribbon Panel, a group of external experts that are appointed to investigate a given problem or question.
“[The opioid crisis] is a complex socio-economic and healthcare-related problem and will not have a simple solution,” he said. “This situation with opioids is an incredibly serious problem and there is significant pressure to find a solution.”
However, while availability and access is one aspect of the epidemic, Hubbard explained there are also other factors to consider.
“The addiction and abuse potential needs to lead to tighter controls particularly for chronic conditions,” he said, adding that alternate pain management approaches need to be evaluated in chronic conditions.
“There has been some very interesting data using Medical Marijuana to reduce the need for high dose opiates to control chronic pain,” he explained. “Alternative and creative approaches such as this need to be developed along with education, social services, and enhanced surveillance.”