Healthy Skepticism Library item: 19518
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Report
Final Compliance Program Guidance for Pharmaceutical Manufacturers
U.S. HHS Office of the Inspector General. 2003 Apr
oig.hhs.gov/.../complianceguidance/042803pharmacymfgnonfr.pdf
Full text:
I. Introduction
The Office of Inspector General (OIG) of the Department of Health and Human Services is continuing in its efforts to promote voluntary compliance programs for the health care industry. This compliance guidance is intended to assist companies that develop, manufacture, market, and sell pharmaceutical drugs or biological products (pharmaceutical manufacturers) in developing and implementing internal controls and procedures that promote adherence to applicable statutes, regulations, and requirements of the federal health care programs1 and in evaluating and, as necessary, refining existing compliance programs.
This guidance provides the OIG’s views on the fundamental elements of pharmaceutical manufacturer compliance programs and principles that each pharmaceutical manufacturer should consider when creating and implementing an effective compliance program. This guide is not a compliance program. Rather, it is a set of guidelines that pharmaceutical manufacturers should consider when developing and implementing a compliance program or evaluating an existing one. For those manufacturers with an existing compliance program, this guidance may serve as a benchmark or comparison against which to measure ongoing efforts.
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A pharmaceutical manufacturer=s implementation of an effective compliance program may require a significant commitment of time and resources by various segments of the organization. In order for a compliance program to be effective, it must have the support and commitment of senior management and the company=s governing body. In turn, the corporate leadership should strive to foster a culture that promotes the prevention, detection, and resolution of instances of problems. Although an effective compliance program may require a reallocation of existing resources, the long-term benefits of establishing a compliance program significantly outweigh the initial costs.
In a continuing effort to collaborate closely with the pharmaceutical industry, the OIG published a notice in the Federal Register soliciting comments and recommendations on what should be included in this compliance program guidance.2 Following our review of comments received in response to the solicitation notice, we published draft compliance guidance in the Federal Register in order to solicit further comments and recommendations.3 In addition to considering the comments received in response to that solicitation notice and the draft compliance guidance, in finalizing this guidance we reviewed previous OIG publications, including OIG advisory opinions, safe harbor regulations (including the preambles) relating to the federal anti-kickback statute,4 Special Fraud Alerts, as well as reports issued by the OIG=s Office of Audit Services and Office of Evaluation and Inspections relevant to the pharmaceutical industry. (These materials are available on the OIG web page at http://oig.hhs.gov.) In addition, we relied on the experience gained from investigations of pharmaceutical manufacturers conducted
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by OIG=s Office of Investigations, the Department of Justice, and the state Medicaid Fraud Control Units. We also held meetings with four groups of industry stakeholders – Pharmaceutical Research and Manufacturers of America (PhRMA) and pharmaceutical manufacturer representatives; health plan and health plan association representatives; representatives of pharmacy benefit managers (PBMs) and representatives of the American Medical Association (AMA) and its member organizations.
