Drugs (11 - 14 of 14 items) in Past Year
Controlled Substances: DEA Should Take Additional Actions to Reduce Risks in Monitoring the Continued Eligibility of Its Registrants
GAO-16-310: Published: May 26, 2016. Publicly Released: Jun 21, 2016.
The Drug Enforcement Administration (DEA) has established controls for determining registrant eligibility to handle and prescribe controlled substances. However, GAO found limitations in DEA's controls to help ensure that individual registrants are and remain eligible and do not present issues that may increase the risk of illicit diversion. GAO's examination of DEA's controlled substances databas...
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...
VA's Health Care Budget: In Response to a Projected Funding Gap in Fiscal Year 2015, VA Has Made Efforts to Better Manage Future Budgets
GAO-16-584: Published: Jun 3, 2016. Publicly Released: Jun 3, 2016.
GAO found that two areas accounted for the Department of Veterans Affairs' (VA) fiscal year 2015 projected funding gap of $2.75 billion.Higher-than-expected obligations for VA's longstanding care in the community (CIC) programs—which allow veterans to obtain care from non-VA providers—accounted for $2.34 billion or 85 percent of VA's projected funding gap. VA officials expected that the Vetera...
Rare Diseases: Too Early to Gauge Effectiveness of FDA's Pediatric Voucher Program
GAO-16-319: Published: Mar 2, 2016. Publicly Released: Mar 2, 2016.
It is too early to gauge whether the Food and Drug Administration's (FDA) pediatric voucher program has stimulated the development of drugs to treat or prevent rare pediatric diseases. Given that the typical drug development process often exceeds a decade, insufficient time has elapsed to determine whether the 3 year-old program has been effective. Any drug sponsors motivated by the program to att...