By Cynthia Schnedar, Greenleaf Health
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) recently released two reports that contain nuggets of interest to those who are watching for trends in the pharmaceutical industry. On November 10, OIG released its Work Plan for 2017, followed on November 17 by Top Management and Performances Challenges Facing HHS. These documents focus on all of HHS, but they both contain sections devoted to the Food and Drug Administration (FDA) and its regulation of the pharmaceutical industry. By taking a closer look at these sections, those outside the agency can gain a valuable insight into what OIG identifies as areas of risk for FDA. This article first explains the role of OIG in providing oversight of FDA, and then discusses what the pharmaceutical industry can learn from these two recent OIG publications.
What Is An OIG?
The Inspector General (IG) Act of 1978, as amended, created the federal inspectors general as independent units charged with combatting fraud, waste, and abuse and promoting integrity and efficiencies within their respective agencies. While inspectors general share their findings with the head of the agency and with Congress; according to the IG Act, they are to remain as “independent and objective” units within an agency. Inspectors General carry out their mission through audits, investigations, and evaluations of their respective agencies. Thus, HHS OIG is an important and independent voice on the challenges facing FDA and what FDA should do to address those challenges.
What Is The Significance Of The Top Management And Performance Challenges Report?
The Reports Consolidation Act of 2000 requires all inspectors general to prepare an annual report on the top management and performance challenges facing the agency it oversees, more commonly known as the Top Management Challenges report.
The 2016 report recently released by OIG identifies 10 management and performance challenges facing HHS, one of which falls directly within FDA’s purview — “ensuring the safety of food, drugs, and medical devices.” OIG noted in the agency’s efforts to ensure the safety of the nation’s drug supply, the agency faces the biggest challenges in addressing drug compounding, the complex drug supply chain, and improper marketing activities. OIG’s comments on each of these three challenges are summarized below.
What Does The HHS OIG Work Plan Say About FDA?
HHS OIG has a tradition of releasing its work plan for the upcoming fiscal year. While inspectors general are statutorily required to issue a Top Management Challenges report, there is no similar requirement to release the annual work plan for an OIG in advance. Not all federal inspectors general issue a public annual work plan, so the HHS OIG annual work plan is an important source of information not afforded to all agencies and to the regulated industries that follow those agencies.
OIG is charged with the oversight of more than 100 programs administered by HHS, and the amount of work conducted concerning various programs is determined by the amount of funds available and the purpose limitations in the funding appropriated to OIG. For example, approximately 78 percent of OIG’s funding in fiscal year 2016 was specifically directed toward oversight of the Medicare and Medicaid programs. Because OIG’s mission is so broad and its resources are limited, it must carefully pick and choose what programs merit its attention. In choosing what to audit or inspect, OIG said it assesses “relative risks in HHS programs and operations to identify those areas most in need of attention.” Not surprisingly, the reviews and inspections identified in the HHS OIG work plan that concern FDA often are designed to assess how well the agency is addressing the relevant challenges identified by OIG in its annual Top Management Challenges report.
In its most recent work plan, OIG announced it anticipates issuing reports on the following three topics during the 2017 fiscal year:
What To Watch For
OIG stated it intends to issue the three reviews described above in fiscal year 2017. Each of those reports will contain not only OIG’s findings, but also recommendations on how FDA can address any OIG findings and FDA’s response to those recommendations. Thus, those anticipated reports should contain yet another valuable assessment of any OIG-identified shortcomings at FDA, and a description of what actions FDA may take to address those shortcomings. In addition, OIG is careful to state that work planning is a dynamic process, and that it adjusts its work plan throughout the year to respond to emerging issues. Therefore, it is worth keeping a look out for any additional reviews OIG may launch in 2017. Those newly launched reviews could be smoke signals for other emerging issues in FDA’s regulation of the pharmaceutical industry.
About The Author:
Cynthia Schnedar is executive VP of regulatory compliance at Greenleaf Health. She was formerly director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research (CDER), where she led a staff of more than 300 doctors, scientists, manufacturing experts, pharmacologists, attorneys, and administrative staff. During her time at FDA, she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Among her many duties, Cynthia advised the FDA commissioner, the CDER director, and other senior FDA officials on significant enforcement issues.
Cynthia spent more than two decades at the Department of Justice (DoJ), where she specialized in compliance and enforcement issues. During her tenure there, she served as acting inspector general and led a nationwide workforce in providing oversight of DoJ. She earned a B.A. from the University of New Mexico and a J.D. from the University of Texas School of Law. You can connect with her on LinkedIn.