ACRO Files Amicus Brief in Sorrell v. IMS Health
Contact: John Lewis
ACRO Files Brief with U.S. Supreme Court to Support Availability
Of Prescription Data for Use in Clinical and Medical Research
April 1, 2011 – WASHINGTON, D.C. – The Association of Clinical Research Organizations (ACRO), which represents the global clinical outsourcing industry to regulators, biopharmaceutical clients, policy makers and the public, has filed an amicus curiae – or friend of court – brief with the Supreme Court of the United States in support of the respondents in the case of Sorrell v. IMS Health, Inc.
At issue in this case is that section of Vermont’s Confidentiality of Prescription Information statute, Vt. Stat. Ann. tit. 18, § 4631 (“Prescriber Information statute”), which prohibits health care analytics companies, such as IMS and Wolters Kluwer Pharma Solutions, and pharmaceutical companies from using prescriber identifiable (“PI”) data in any manner to facilitate the marketing or promotion (even if truthful) of name brand prescription medicines. While the Vermont statute provides for an exception for the data to be used for research purposes, ACRO is concerned that without a broader market for the data there would not be an adequate economic incentive for the data to be gathered for commercial or research purposes.
“We see a disturbing trend toward unnecessary restrictions being placed on the use of medical data, which can result in making research more time-consuming and expensive,” said Doug Peddicord, Ph.D., Executive Director of ACRO. “Potentially, these overreaching restrictions on data access and usage may limit the ability of clinical researchers to appropriately identify physicians for participation in clinical trials, target patient populations, or measure drug safety and effectiveness.”
Peddicord continued: “To be clear, the data in question in the IMS case meets the standards of HIPAA and is not ‘personally identifiable health information’ so privacy is not the issue here. ACRO wanted to weigh in on this case to prevent further restrictions on access to de-identified data that is important to medical research.”
Oral arguments in Sorrell v. IMS Health will be heard at the Supreme Court on April 26 with a decision likely by the end of June. Essentially, the case revolves around important First Amendment issues of free speech.
The ACRO amicus brief, prepared by Cleary Gottlieb Steen & Hamilton LLP, Washington, DC, argues, in part:
“Prescriber identifiable (“PI”) data are used by a wide array of organizations, including pharmaceutical companies, CROs, academic researchers, public health agencies, and government law enforcement agencies, among others. For CROs, pharmaceutical companies, academic researchers, and other health researchers directly involved in the development of new medicines, PI data are important and useful in conducting this work. Without this data, it would be more difficult for these groups to design clinical trials to test new medicines, identify doctors to participate in clinical trials, recruit patients who would most likely benefit from a new treatment, and compare the efficacy of new medicines to those already on the market. While it would be possible to design and develop clinical trial programs without PI and other de-identified health data, researchers would find the process more expensive and subject to delay, which, in some cases, could compromise the sustainability of the research project altogether.
“PI data make it possible for CROs and others to conduct clinical trials more efficiently because this data accelerate finding patients with the disease that a given medicine or treatment is designed to address and the physicians who treat them. Researchers can then approach this targeted set of physicians to learn more about the efficacy of existing therapies and, if appropriate, invite their patients to participate in clinical trials. The more quickly researchers can locate clinically appropriate subjects, the more quickly the safety and efficacy of a new compound can be determined, the more quickly the FDA can approve a new drug application, and the medicine can be available to the public.”
To receive a copy of the full brief, please contact ACRO’s VP of Public Affairs, John Lewis, at 202.464.9340 or by email at [email protected].
The Association of Clinical Research Organizations (ACRO) represents companies whose focus is clinical research. The association provides an active voice for the global CRO industry, which provides specialized services that are integral to the discovery and development of drugs, biologics, vaccines and medical devices. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ approximately 70,000 professionals worldwide and annually conduct more than 9,000 clinical trials involving nearly 2 million participants in 115 countries. For more information, please visit www.www.acrohealth.org.