The Government Accountability Office (GAO) and the United States Pharmacopeia (USP) asserted in two recent reports that the regulators need to address some of the ambiguities associated with advanced manufacturing to accelerate adoption in the pharmaceutical industry. The GAO further recommended that the US Food and Drug Administration (FDA) should set benchmarks to better measure uptake to this mode of manufacturing.   A USP official discussed both reports, as well as...

The US Food and Drug Administration (FDA) needs to do a better job of tracking and monitoring the activities of institutional review boards (IRBs); not doing so compromises the safety of research participants enrolled in clinical trials, according to a new report from the Government Accountability Office (GAO). These findings also apply to the Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP).   The 16 February report describes...

In a report to the Department of Health and Human Services (HHS) published on Thursday, the Government Accountability Office (GAO) outlines five priorities for the US Food and Drug Administration (FDA) to address to meet its public health mission.   In the report, addressed to HHS Secretary Xavier Becerra, GAO calls for Becerra’s personal attention in addressing 61 open priority recommendations for the department and its sub agencies, 43 of which are holdovers from las...

The Operation Warp Speed (OWS) goal to produce 300 million COVID-19 vaccine doses by January 2021 was not met, according to a status report released by the US Government Accountability Office (GAO).   Companies with current emergency use authorizations (EUAs) for vaccines are contracted under the program to release a combined 200 million doses of their vaccines by the end of March 2021 but had released just 63.7 million doses (31.8%) as of 31 January 2021, the report n...

In a nearly 350-page report to Congress on the federal government’s COVID-19 response, the Government Accountability Office (GAO) calls on the US Food and Drug Administration (FDA) to review its inspections approach and come up with a plan to address its looming backlog.   Pandemic inspection alternatives   In the early days of the pandemic, FDA halted non-mission-critical foreign and domestic inspections and relied on alternative tools, such as inspection reports ...

The US Government Accounting Office (GAO) found that many elements of an effort to improve laboratory safety at the Food and Drug Administration (FDA) have not been met, over three years after establishing an Office of Laboratory Safety. For example, the safety oversight office still cannot perform unannounced laboratory inspections, according to the report .   Prompted by the 2014 discovery of boxes of smallpox virus that were improperly stored in a laboratory cold r...

The United States continues to struggle with shortages of personal protective equipment (PPE) and testing supplies due to high global demand and the fact that most supplies are made outside of the US, according to new findings from the US Government Accountability Office (GAO).   In a wide-ranging report on the US federal response to COVID-19, the GAO issued 16 new recommendations for federal agencies spanning the medical supply chain, vaccines and therapeutics, COVI...

The Government Accountability Office (GAO) announced Friday that it has found that the US Food and Drug Administration (FDA) does not always ensure that all information is consistently recorded and evaluated when making orphan drug designation determinations. The missing of these critical steps by the agency in some cases means that FDA reviewers do not fully understand the context of a drug’s intended use for the rare disease, GAO said. “The Commissioner of FDA shou...

The Government Accountability Office (GAO) has told the US Food and Drug Administration (FDA) to develop metrics to evaluate its performance in implementing its least burdensome approach to regulating medical devices, according to a report released on Tuesday. Congress first required FDA to implement a least burdensome approach for reviewing 510(k) and premarket application (PMA) submissions in the 1997 Food and Drug Administration Modernization Act (FDAMA) . Since then...

The US Government Accountability Office (GAO) on Tuesday called on the US Food and Drug Administration (FDA) to announce plans to issue or revise guidance for complex generic drugs and FDA said it agrees with the recommendation and is working to do just that. The 50-page GAO report comes as FDA has sought to improve the way it reviews and approves these complex generic drugs, which can have a complex formulation, active ingredient, route of delivery, dosage form or ...

The US Government Accountability Office (GAO) on Tuesday released a new report on the pharmaceutical industry's sales and expenses related to research and development (R&D), noting that the amount of money people spend on prescription drugs has nearly doubled since the 1990s, mostly because of brand-name drugs. Retail prescription drug expenditures were estimated to account for about 12% of total personal health care service spending in the US in 2015, up from abou...

The House Energy & Commerce Committee on Tuesday held a hearing to discuss a "Right-to-Try" bill passed in the Senate that the US Food and Drug Administration (FDA) is seeking to change. The hearing discussed a bill that would seek to undercut FDA’s oversight of a program, known as expanded access, whereby terminally ill patients and their doctors can request access to an investigational drug outside of a clinical trial. Right-to-Try laws have now passed in 37 states...