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.
The FDA is releasing a draft guidance on developing drugs and biologics to treat acute myeloid leukemia (AML). The draft discusses the overall development program and trial designs for AML indications, including those limited to an individual phase of treatment, such as maintenance or transplantation preparative regimen. The guidance addresses general drug development, efficacy endpoints, and exploratory and confirmatory trial considerations. The FDA noted that the expansion of treatment intent, a broadening of the intended population and development of a range of new drug classes as alternatives to cytotoxic drugs are contributing to the complexity of clinical development programs for new AML drugs. Comments on the draft should be submitted to Docket No. FDA-2020-D-1298 by Oct. 12.
The U.K.’s Medicines and Healthcare Products Regulatory Agency is extending its deadlines for manufacturer authorization holders to review their human drug manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities. The agency also is widening the scope of the review to cover all human drugs, including chemically synthesized active pharmaceutical ingredients and biologics, authorized in the EU/EEA and the U.K. The new deadlines for submitting the risk evaluation are March 31, 2021, for chemical drugs and July 1, 2021, for biologics. Mitigation plans will be due later.
As a next step in the modernization of its new drugs regulatory program, the FDA will hold a virtual public workshop Oct. 30 to get feedback on the integrated review documentation generated by its new integrated assessment of marketing applications for new drugs. Written comments will be due by Dec. 30, according to a notice scheduled for publication in Thursday’s Federal Register.
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.
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 also said 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 adds 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.