Drugs (1 - 6 of 6 items) in Past 6 Months
Antibiotics: FDA Has Encouraged Development, but Needs to Clarify the Role of Draft Guidance and Develop Qualified Infectious Disease Product Guidance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 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...
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...
Opioid Addiction: Laws, Regulations, and Other Factors Can Affect Medication-Assisted Treatment Access
GAO-16-833: Published: Sep 27, 2016. Publicly Released: Oct 27, 2016.
The Department of Health and Human Services (HHS) has stated that addressing opioid abuse is a high priority and is promoting access to medication-assisted treatment (MAT)--an approach that combines behavioral therapy and the use of medications--to combat the problem. Three medications are currently approved for use in MAT for opioid addiction--methadone, buprenorphine, and naltrexone. Methadone a...