Toronto, Canada (PRWEB) January 14, 2014
In recent years, growing suspicion about the pharmaceutical industry and its motives and methods in product development and promotion has led to unprecedented levels of public mistrust of the industry. This mistrust, fueled by concerns about the insidious impact of commercialization of research, has been further fed by reports of spectacular fines to the world’s biggest pharmas for illegal marketing activities, allegations of industry suppression of negative clinical trial results, and fears of “influence peddling” through physician payments of various sorts.
The Physician Payments Sunshine Act (“The Sunshine Act”) is the US Congress’s response to these concerns. The Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals.
Manufacturers are required to collect and track payment, transfer and ownership information beginning Aug. 1, 2013. Manufacturers will submit the reports to the Centers for Medicare & Medicaid Services (CMS) on an annual basis. In addition, manufacturers and group purchasing organizations (GPOs) must report certain ownership interests held by physicians and their immediate family members. The majority of the information contained in the reports will be available on a public, searchable website.
These new reporting requirements have imposed a considerable burden on all concerned, including IRBs, sponsors, CROs, clinical investigators, and certainly government. Will this added regulatory burden prove effective in promoting more ethical research with improved outcomes for patients and society?
For more information about this event or to register, visit The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation.
About IRB Services
Founded in 1993, IRB Services is an independent organization dedicated to protecting the rights and safety of human research subjects. As one of the largest central institutional review boards in North America, IRB Services is an experienced, service-driven organization dedicated to excellence in human research participant protection and committed to providing industry leading efficient customer-oriented services. IRB Services provides ethical review of clinical trials and behavioral science research and operates ethics committees in Boca Raton, Florida; Montréal, Québec; and Toronto, Ontario; which review a wide range of both industry and publicly funded human subject research across multiple disciplines, including Food and Drug Administration, US Department of Health and Human Services, and Health Canada regulated research. IRB Services has received full accreditation from the Association for the Accreditation of Human Research Protection Programs. For more information please visit http://www.irbservices.com.
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