Health care (1 - 7 of 7 items) in Past Year
Antibiotics: FDA Has Encouraged Development, but Needs to Clarify the Role of Draft Guidance and Develop Qualified Infectious Disease Product Guidance
GAO-17-189: Published: Jan 31, 2017. Publicly Released: Mar 2, 2017.
The Food and Drug Administration (FDA) released updated or new guidance for antibiotic development, and used the qualified infectious disease products (QIDP) designation to encourage the development of new antibiotics. As of August 2016, FDA, an agency within the Department of Health and Human Services (HHS), had coordinated the release of 14 updated or new guidance documents on antibiotic develop...
Foster Care: HHS Has Taken Steps to Support States' Oversight of Psychotropic Medications, but Additional Assistance Could Further Collaboration
GAO-17-129: Published: Jan 5, 2017. Publicly Released: Feb 6, 2017.
State child welfare and Medicaid officials in seven selected states reported a variety of practices to support the appropriate use of psychotropic medications, which affect mood, thought, or behavior, for children in foster care. Practices include screening for mental health conditions, developing prescription guidelines, and monitoring a child's health while on medication. Additional state effort...
Drug Compounding: FDA Has Taken Steps to Implement Compounding Law, but Some States and Stakeholders Reported Challenges
GAO-17-64: Published: Nov 17, 2016. Publicly Released: Nov 17, 2016.
GAO's survey of state pharmacy regulatory bodies found that drugs are compounded in a variety of health care settings, and some data are collected on the number of entities that compound drugs (drug compounders), but not the volume of compounded drugs. In addition to pharmacies, drug compounding settings include physicians' offices and outsourcing facilities—a new type of facility established by...
Generic Drugs Under Medicare: Part D Generic Drug Prices Declined Overall, but Some Had Extraordinary Price Increases
GAO-16-706: Published: Aug 12, 2016. Publicly Released: Sep 12, 2016.
Generic drug prices declined overall under Medicare Part D—the voluntary outpatient prescription drug program administered by the Centers for Medicare & Medicaid Services within the Department of Health and Human Services (HHS)—since 2010. Specifically, generic drug prices fell 59 percent from the first quarter of 2010 through the second quarter of 2015. This decline reflects a changing basket...
Medicare Part B: CMS Should Take Additional Steps to Verify Accuracy of Data Used to Set Payment Rates for Drugs
GAO-16-594: Published: Jul 1, 2016. Publicly Released: Aug 1, 2016.
In 2014, the most recent year for which data were available, the Medicare program and its beneficiaries spent about $21 billion on approximately 46 million administrations of 551 Part B drugs paid based on average sales price (ASP). Six drugs—each exceeding $1 billion in expenditures—accounted for 36 percent of all expenditures on Part B ASP drugs, while a different 10 drugs—each administere...
Drug Shortages: Certain Factors Are Strongly Associated with This Persistent Public Health Challenge
GAO-16-595: Published: Jul 7, 2016. Publicly Released: Jul 7, 2016.
When available supplies of prescription drugs are insufficient, patient care may be adversely affected. The number of new shortages has generally decreased since 2011, while the number of ongoing shortages remained high.Number of Drug Shortages from January 2010 through December 2015 To help address shortages, the Food and Drug Administration (FDA) prioritized the review of—more quickly reviewed...
Food and Drug Administration: Comprehensive Strategic Planning Needed to Enhance Coordination between Medical Product Centers
GAO-16-500: Published: May 16, 2016. Publicly Released: Jun 15, 2016.
The Food and Drug Administration (FDA) developed a strategic integrated management plan (SIMP) for its three centers that oversee medical products (biologics, drugs, and medical devices); however, GAO found that the plan does not incorporate leading practices for strategic planning or document a comprehensive strategy for the centers. FDA officials explained that circumstances at the time of the S...