Krishnamoorthi eyes ventilator contract

Rep. Raja Krishnamoorthi (D-Ill.), of the House Oversight Committee, penned a Jan. 26 letter to Automedx Inc., of Addison, Texas, requesting information about a contract between Automedx and the Department of Defense for ventilators. Krishnamoorthi said the purchase of the company’s ventilators from Combat Medical Systems for $16.2 million may have been for ventilators that are not adequate for treatment of patients with COVID-19 due to concerns revolving around modifications made to the devices to improve volume rate and pressure. One of the concerns is that the procurement process may have been tainted by Automedx founder Adrian Urias and members of the Trump administration. Krishnamoorthi requested copies of all documents related to contracts between the company and the federal government in relation to the ventilators.

TGA fines company for failure to provide masks

Australia’s Therapeutic Goods Administration (TGA) said it had fined Life Biotech Pty Ltd. slightly more than $106,000 in connection with a purported failure to provide the agency with face masks upon request for the TGA’s review. The request for masks and associated information was part of the TGA’s postmarket review of the items. The agency also said Life Biotech had provided false and misleading information about the masks.

U.S. PPE hoarder indicted

The U.S. Department of Justice has charged a businessman in Mississippi with defrauding federal health programs and other entities in a scheme to hoard $1.8 million in personal protective equipment (PPE) needed for the COVID-19 pandemic. Kenneth Bryant Ritchey, of Ocean Springs, Miss., is alleged to have attempted to charge customers as much as $25 for N95 masks, despite having obtained the articles at “a much lower price.”

CAP supports Defense Production Act

The College of American Pathologists (CAP) advised the Biden administration in a Jan. 27 letter that despite that testing capacity in the U.S. has expanded “dramatically” in response to the COVID-19 pandemic, labs are still struggling to obtain sufficient volumes of supplies such as pipettes and swabs. CAP President Patrick Godbey said better transparency and communication about the prioritization and distribution of current COVID-19 supplies “will help clinical laboratories manage their testing strategies at the local level, and that officials at the Department of Health and Human Services should consult more frequently with manufacturers about supply levels. The group also supports the use of the Defense Production Act to help manage supply shortages, but Godbey acknowledged that the DPA will have no effect on supplies obtained from manufacturers in other nations. Nonetheless, he said, CAP “would still urge the government to leverage its authorities to further assist manufactures in meeting the current and future demands for COVID-19 testing.”

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.

GAO: More needs to be done to respond to COVID-19

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 and 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 fully 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 preparedness for future pandemics. 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 Joe 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 existing scientific-integrity 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 promising 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.