In its latest report on the implementation of the CARES Act, the U.S. Government Accountability Office (GAO) said it remains “deeply troubled by the lack of sufficient federal action” to address critical gaps in responding to the COVID-19 pandemic.
One example it cited is that a clear, comprehensive federal vaccine distribution plan is still just a work in progress.
Although 27 of the 31 recommendations the GAO has made in previous reports have yet to be implemented, the office made 13 new recommendations in its Jan. 28 report. Those recommendations are aimed at improving federal agencies' public health and economic recovery efforts, including a national testing strategy and other steps to be better prepared for future public health emergencies.
The GAO noted that the Department of Health and Human Services (HHS) has provided Congress with reports on its national testing strategy, but it hasn’t made the details of the strategy public. “Without a comprehensive, publicly available national strategy, HHS is at risk of key stakeholders and the public lacking crucial information to support an informed and coordinated testing response,” the GAO said as it recommended that HHS develop and make publicly available a comprehensive national COVID-19 testing strategy.
The report also recommended that as the FDA makes changes to its collection of drug manufacturing data, it should ensure the information is complete and accessible so it can be used to help identify and mitigate supply chain vulnerabilities. In addition to working with manufacturers and other federal agencies, the FDA may need to seek the authority to obtain necessary information, the GAO said.
Also, as the FDA develops its inspection plans for future fiscal years, it should identify, analyze and respond to the issues resulting from the current backlog of inspections that could jeopardize its goal of risk-driven inspections, the GAO said. In addition, the agency should assess its alternative inspection tools to determine whether they could provide the information needed to supplement regular inspection activities or help meet drug oversight objectives when inspections aren’t possible in the future.
Another recommendation is that as HHS refines and implements a supply chain strategy for pandemic preparedness, including the role of the Strategic National Stockpile, the Assistant Secretary for Preparedness and Response should establish a process to regularly engage with Congress and other stakeholders – such as industry and state, local, tribal and territorial governments – to help guide that strategy.
Additionally, the GAO urged HHS to immediately establish an expert committee or use an existing one to systematically review and inform the alignment of ongoing data collection and reporting standards for key health indicators to improve the federal government's response to COVID-19 and future pandemic preparedness. The committee should include a broad representation of health care professionals from academia, nonprofits, and other public and private sectors, the GAO said.
Biden orders review of scientific-integrity policies
Amid his ongoing flurry of executive orders, U.S. President Je Biden issued a memo Jan. 27 to his Cabinet members and federal agencies stressing that his administration’s policy is to make evidence-based decisions guided by the best available science and data.
The memo tasks the director of the Office of Science and Technology Policy with ensuring that all departments and agencies establish and enforce scientific-integrity policies banning improper political interference in the conduct of scientific research and in collecting scientific or technological data. The policies also must prevent the suppression or distortion of scientific or technological findings and data.
In addition, the memo calls for the convening of an interagency task force of the National Science and Technology Council and gives the task force 120 days to review the effectiveness of agency scientific-integrity policies that have been developed since the issuance of an Obama-era presidential memo on scientific integrity.
The review is to include an analysis of instances in which the existing policies haven’t been followed or enforced, including whether those instances resulted in political interference; led to the suppression or distortion of scientific or technological findings or data; disproportionately harmed federal scientists and researchers from groups that are historically underrepresented in science and technology; or impeded the equitable delivery of federal programs.
As part of its review, the task force is to identify effective practices regarding engagement of federal scientists with news media and on social media; policies that protect scientific independence during clearance and review; approaches for handling disagreements about scientific methods and conclusions; reporting practices that promote transparency in implementing scientific-integrity policies and in handling misconduct allegations; ways to minimize conflicts of interest; and opportunities to address gaps in the current policies related to emerging technologies, such as artificial intelligence and machine-learning, and evolving scientific practices, including citizen science and community-engaged research.
Canada to build rare disease drug strategy
As part of its commitment to establishing a national, universal pharmacare program, Health Canada is seeking feedback from patients with rare diseases and interested stakeholders to shape a rare-disease strategy to help Canadian families access and save money on high-cost drugs.
The Canadian government has issued a discussion paper to guide the conversation and set up an online questionnaire for comments. Stakeholders also may submit written comments and participate in one of five town halls that will be held from Feb. 9 to March 23.
The online consultations will close March 26.
South African variant in U.S.
The U.S. CDC reported Jan. 28 that the first U.S. documented cases of the South African B 1.351 variant of SARS-CoV-2 have been identified in South Carolina.
“Like the U.K. and Brazilian variants, preliminary data suggests this variant may spread more easily and quickly than other variants,” the CDC said. But at this time, there’s no evidence that the variant causes more severe disease, the agency added.