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 OIGs 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.
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 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.
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