With all the focus of late on the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP), the FDA’s 30-plus advisory committees have been flying under the radar, especially since many of them haven’t met for a few years now.
Driven by prescription drug prices and oft-repeated claims that nearly every drug developed in the U.S. owes its origins to taxpayer-funded research, watchdog groups and some lawmakers have led demands over the years for price to be considered a “reasonableness” factor in determining whether the government can march in on patents under the Bayh-Dole Act.
The U.S. Government Accountability Office said in a recent report that the Medicare national coverage determination process could use a few adjustments, but the report also pointed to significant resource problems associated with the process, a source of drag that only Congress can fix.
The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office raised the question of whether organ-on-a-chip methods are ready to fill the gap.
The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office raised the question of whether organ-on-a-chip methods are ready to fill the gap.
The lingering effects of the COVID-19 pandemic and ongoing recruitment/retention issues are making it difficult for the U.S. FDA’s bioresearch monitoring program to keep up with the on-site clinical research inspections that are a cornerstone of the preapproval process for new drugs, biological products and medical devices. The resulting delays could threaten the approval timelines for many products.
More than one U.S. federal government agency is tasked with keeping track of fraud and abuse of federal health programs, but a new report by the Government Accountability Office (GAO) suggests there is more work to be done. The GAO report said that one of the key issues with fraud and abuse writ broadly is that the terms and definitions are used inconsistently, and that a fix for this and other problems might capture more fraud, which may in turn indirectly put more medical device makers at risk for such allegations.
The process used by Patent Trial and Appeal Board (PTAB) at the U.S. Patent and Trademark Office PTO) to review patent disputes has become an issue yet again, thanks to a report by the Government Accountability Office (GAO). According to the GAO report, 75% of respondents to a survey of PTAB judges said that oversight practiced at PTO affected their independence in adjudicating cases, but that view was not universally held by these judges, leaving stakeholders with a vague picture as to the nature of the processes handled by the PTAB.
The process used by Patent Trial and Appeal Board (PTAB) at the U.S. Patent and Trademark Office PTO) to review patent disputes has become an issue yet again, thanks to a report by the Government Accountability Office (GAO). According to the GAO report, 75% of respondents to a survey of PTAB judges said that oversight practiced at PTO affected their independence in adjudicating cases, but that view was not universally held by these judges, leaving stakeholders with a vague picture as to the nature of the processes handled by the PTAB.
The issue of life science espionage continues to reverberate across the U.S., and a new report by the Office of Inspector General (OIG) suggests that vulnerabilities in the U.S. have not been adequately addressed. The OIG report said that more than two thirds of NIH grantees failed to meet at least one requirement for investigator disclosures about their activities related to foreign entities, including governments, a problem OIG says is in dire need of a fix.
