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ACRO Testifies About Clinical Trials in New Jersey

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On October 19 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will be revised or withdrawn is expected before the end of the year.

About ACRO

The Association
of Clinical Research Organizations
 (ACRO) represents companies
that provide a variety of specialized services that support the
development of new pharmaceuticals, biologics, and medical devices. ACRO
member companies employ more than 130,000 professionals worldwide and
conduct research in more than 100 countries. The ACRO testimony is
available at www.acrohealth.org;
also visit ACRO at Twitter @acrohealth.
YouTube @ACROHealthChannelFacebookLinkedIn.

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