Prescription drugs (1 - 10 of 11 items) in Past Year
Drug Safety: FDA Has Improved Its Foreign Drug Inspection Program, but Needs to Assess the Effectiveness and Staffing of Its Foreign Offices
GAO-17-143: Published: Dec 16, 2016. Publicly Released: Jan 17, 2017.
The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), has increased its foreign drug inspections and enhanced its ability to prioritize drug establishments for inspection. The number of foreign inspections has consistently increased each year since fiscal year 2009. Beginning in fiscal year 2015, FDA conducted more foreign than domestic inspect...
FDA Facilities: Planning Efforts for White Oak Campus Should Further Incorporate Leading Practices to Address Ongoing Challenges
GAO-17-87: Published: Dec 7, 2016. Publicly Released: Jan 6, 2017.
Officials from the Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS) described various benefits and challenges related to the consolidation of about 10,500 FDA staff and contractors at a campus in White Oak, Maryland. As of 2016, the campus was partially complete, with 9 of the 10 planned office buildings constructed and 27 percent more staff than the 8,2...
Prescription Drug Labels: Actions Needed to Increase Awareness of Best Practices for Accessible Labels for Individuals Who are Blind or Visually Impaired
GAO-17-115: Published: Dec 9, 2016. Publicly Released: Dec 9, 2016.
GAO found that some pharmacies can provide accessible prescription drug labels, which include labels in audible, braille, and large print formats and are affixed to prescription drug containers.Mail order pharmacies: Four pharmacy benefit managers (PBMs) used by large insurers that GAO contacted reported that they can provide accessible labels through their mail order pharmacies.Retail pharmacies...
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...
Highlights of a Forum: Preventing Illicit Drug Use
GAO-17-146SP: Published: Nov 14, 2016. Publicly Released: Nov 15, 2016.
What Forum Participants SaidIn individual presentations and group discussion, participants in a forum that GAO convened identified the common factors related to illicit drug use--the use of illicit drugs and the misuse of prescription drugs. According to forum participants, illicit drug use typically occurs for the first time in adolescence and involves marijuana. Forum participants also discussed...
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...
Physician-administered Drugs: Comparison of Payer Payment Methodologies
GAO-16-780R: Published: Aug 1, 2016. Publicly Released: Aug 31, 2016.
Payment methodologies for physician-administered drugs varied across Medicare fee-for-service, Medicaid fee-for-service, the Department of Veterans Affairs (VA) health care system, the VA Choice program, and two large private payers GAO reviewed. Compared to Medicare, other federal payers generally paid rates that were the same or lower. For example, for 10 high-expenditure drugs, VA paid rates th...
Medicare Part B: Data on Coupon Discounts Needed to Evaluate Methodology for Setting Drug Payment Rates
GAO-16-643: Published: Jul 27, 2016. Publicly Released: Aug 26, 2016.
In 2015, manufacturers of 29 of the 50 high-expenditure Medicare Part B drugs GAO analyzed offered coupon programs, which reduce the costs patients incur for specific drugs. Part B drugs are typically administered by a physician. Coupon programs are prohibited in the Medicare program but are generally available to privately insured patients. GAO obtained data on coupon discounts for 18 drugs. GAO...
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...