Federal Reports

FDA approves new drugs for sale in the United States through the new drug application (NDA) review process. FDA requires all new drugs to undergo clinical testing to demonstrate their safety and efficacy prior to approval. However, premarket clinical trials may not always identify or fully characterize risks. Postmarketing research can provide additional information about the risks, benefits, and optimal use of an approved drug. In 2006, the Office of Inspector General (OIG) found that FDA could not readily identify whether or how timely postmarketing studies were progressing toward completion, and that FDA lacked an effective monitoring system for postmarketing studies. Since then, the Food and Drug Administration Amendments Act (FDAAA) expanded FDA's authority to require postmarketing studies and to take enforcement action when sponsors are out of compliance. This study follows up on OIG's previous work in light of FDA's expanded authority.

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The Federal Maritime Commission OIG reviewed the system of quality control for the audit organization of the EAC OIG in effect for the year ended March 31, 2015. This report discusses their findings.

This report is part of a series on adverse events in health care settings, defined as harm resulting from medical care. Previous OIG work identified harm rates of about 30 percent in both acute-care hospitals and skilled nursing facilities (SNF), with an attendant toll on patient health and taxpayers' costs, the latter amounting to billions of dollars annually. This report extends our work by evaluating care provided in rehabilitation (rehab) hospitals. Rehab hospitals are post-acute providers that specialize in intensive rehabilitative care for patients recovering from illness, injury, or surgery. While in recent years stakeholders have paid considerable attention to patient safety in acute-care hospitals and increasingly in SNFs, less is known about adverse events in other health care settings. An increased understanding of adverse events that occur in this unique setting would better equip health care providers and other stakeholders in taking actions to improve the safety of patient care in rehab hospitals.