ACRO Executive Director Doug Peddicord, Ph.D., testified at a public hearing of the New Jersey Division of Consumer Affairs about a regulation that, if adopted, would have a devastating impact on the availability of clinical trials for patients in New Jersey and cripple the ability of New Jersey physicians to conduct industry-sponsored clinical trial research on investigational therapies.
The regulation, proposed by the Christie administration as a way to address the opioid crisis, would set a cap of $10,000 per year on payments by biopharmaceutical companies to physicians for services ranging from speaking at continuing education events to consulting on the development of new drugs and treatments. In his testimony Dr. Peddicord pointed out that this $10,000 cap would apply also to clinical trial grants, which typically include the fair-market costs of medical equipment and supplies, tests and laboratory services, and expense compensation to patients, as well as research staff salaries and the host of other activities required to produce accurate data for the FDA to evaluate the safety and effectiveness of a new drug.
“Because ACRO member companies often distribute clinical trial grants on behalf of manufacturers and understand the true costs of conducting a clinical trial, which might run from $10,000 to $20,000 per patient over the course of a months-long trial involving breast or prostate cancer, for instance, we thought it extremely important to request that New Jersey revise the proposed regulation to exclude such payments,” said ACRO Chairman and President and CEO of Bioclinica, John Hubbard. “However well-intentioned, if this regulation does not exempt payments to doctors to run clinical trials it will be impossible to enroll a single patient in many trials and the state’s position as a major hub of biomedical innovation will be destroyed.”
Also testifying at the public hearing were representatives of the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization (BIO), Bio NJ, the Medical Society of New Jersey, the HealthCare Institute of New Jersey, and others, many of whom noted the extraordinary threat to medical research posed by the regulation as currently written. A decision on whether the proposed rule will be revised or withdrawn is expected before the end of the year.