The U.S. Department of Justice said its report regarding updates to the Administrative Procedures Act (APA) is intended to “encourage and inform much-needed action by Congress to modernize the APA.” The 129-page report is based largely on presentations made in a December 2019 summit, but deputy attorney general Jeffrey Rosen said in the foreword that the cost of compliance with federal regulations may be as much as $2 trillion per year. Rosen said also that the courts have “significantly changed the regulatory process through so-called ‘administrative common law’,” although the executive branch is credited with making regulatory processes “more efficient and accountable.” The report noted that the federal government added an average of 61 significant new rules between 2017 and 2018, less than 25% of the annual average of 279 such rules imposed between 2000 and 2016. BioWorld will cover this report in greater depth in an upcoming issue.
The U.S. FDA updated its FAQ page for the COVID-19 pandemic, including information on registration and listing, which said that the agency is offering no waiver of registration fees for the pandemic. The agency advised that it may need 90 days to assign a registration number for an applicant facility. Entities that import or otherwise obtain N95 masks or personal protective equipment (PPE) for personal or institutional use need not register with the agency, unless that entity owns or operates the manufacturing facility. Any intent to sell such items requires listing, however. The FDA also updated its FAQ for importation of masks and PPE, stating that entities can import general-purpose face masks from China.
The U.S. Department of Health and Human Services said it will award $2.5 million in funding from the CARES Act for five cooperative agreements for development or improvement of health information exchanges (HIEs) that will be used to support state and local health agencies. The HIEs will be expected to improve services by completing last-mile connectivity and data services that will improve state and local responses to the current and future pandemics.
The American Medical Association (AMA) and Snomed International said they have launched a demonstration project to highlight how the CPT coding system and the Snomed CT standards can work together to promote better organization of health care data. The associated demonstration tool will allow health care administrators to use both coding sets “to align resources to population needs in complex clinical areas,” the AMA said, a list that includes breast cancer diagnosis and treatment.
The FDA posted an update to the adverse event (AE) database for the Essure sterilization device by Bayer AG, of Leverkusen, Germany, which includes a spreadsheet of AEs in connection with ongoing product liability litigation. Benjamin Fisher, director of the reproductive devices office at the FDA’s Center for Devices and Radiological Health, said the updated spreadsheet was drawn on “information from certain social media sources.” Fisher acknowledged that the information may thus replicate information that has already been reported to the agency, and consequently “do not necessarily represent new adverse events.” Bayer will continue to update the spreadsheets through April 2021.
COVID-19 could have a lingering impact on public health across the Americas, as it threatens regional plans to eliminate and control other infectious diseases such as tuberculosis (TB), HIV and hepatitis. Last October, members of the Pan American Health Organization (PAHO) committed to a region-wide approach to eliminate more than 30 communicable diseases and related conditions in the Americas by 2030. “The progress to achieving this milestone is now under threat, due to the burden of COVID-19 on health systems and the disruption of essential services, including priority disease control programs, elimination initiatives and routine immunization,” PAHO Director Carissa Etienne said at a media briefing Tuesday. She noted that 80% of the countries in Latin America and the Caribbean have reported challenges in delivering TB treatments during the pandemic, which means manageable cases of TB could turn into active infections. A third of the countries reported disruptions in hepatitis screenings. Additionally, 30% of people living with HIV in the region are avoiding seeking care, and antiretroviral medications are in limited supply. While there has been a 40% reduction in the number of reported mosquito-borne diseases in the region, those numbers are questionable as testing for the diseases has been greatly reduced by the pandemic, Etienne explained. COVID-19 also has interrupted mass drug administration campaigns that are vital to elimination efforts “just as we were making significant progress against neglected tropical diseases, like lymphatic filariasis, schistosomiasis and soil-transmitted helminthiases,” Etienne said.
As part of its preparation for an annual congressional report, the Office of the U.S. Trade Representative is seeking public comment on Russia’s implementation of its obligations as a member of the World Trade Organization. Topics of interest include Russia’s import and export regulations, government subsidies, standards and technical regulations, trade-related investment measures such as local content requirements, intellectual property rights, and government procurement practices. Comments should be submitted to Docket Number USTR-2020-0032 by Sept. 21.