The 194 members of the World Health Organization (WHO) signed off on a resolution Tuesday calling for an “impartial, independent and comprehensive evaluation” of the organization’s response to COVID-19, including the timeline of that response. The evaluation, which should be initiated at the “earliest appropriate moment,” needs to consider lessons learned and include recommendations for improving the global response and preparedness for future pandemics, according to the resolution. It also called for sustainable funding for WHO and a coordinated response as the pandemic continues, ensuring a fair distribution of vaccines, therapies and supplies. The resolution isn’t limited to WHO’s actions, as it urged other international organizations and stakeholders to address “the proliferation of disinformation and misinformation particularly in the digital sphere, as well as the proliferation of malicious cyber-activities that undermine the public health response, and support the timely provision of clear, objective and science-based data and information to the public.” The vote on the resolution came a day after U.S. President Donald Trump wrote to WHO Director-General Tedros Adhanom Ghebreyesus giving him 30 days to commit to major substantive improvements in the way the organization is handling the pandemic – otherwise Trump said his April 14 suspension of U.S. contributions to WHO would become permanent. The letter provided a timeline of the organization’s response and laid out Trump’s concerns about how it ignored increasing international unease about the coronavirus in December and early January while failing to require transparency from China. “It is clear the repeated missteps by you and your organization in responding to the pandemic have been extremely costly for the world,” Trump told Tedros. “The only way forward for the World Health Organization is if it can actually demonstrate independence from China.”
The development and distribution of COVID-19 vaccines will be one area of focus as the U.S. House Energy and Commerce Subcommittee on Oversight and Investigations continues its oversight of the Trump administration’s response to the pandemic. “This will include examining public-private partnerships under the Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH), efforts at BARDA to assess and increase vaccine production capabilities, activities at FDA to support efficient and timely review of vaccines and vaccine candidates, and interagency coordination of a national COVID-19 vaccine plan,” the subcommittee said in its oversight plan that was released this week. Other priorities for the subcommittee include the administration’s commitment to science and public health, testing and contact tracing, and the supply chain for personal protective equipment.
With parts of the U.S. beginning to reopen, Trump issued an executive order Tuesday calling on federal departments and agencies to use similar regulatory flexibilities practiced in fighting COVD-19 to address the nation’s economic recovery. Toward that end, the order instructed agencies to review regulatory standards that were temporarily rescinded, suspended, modified or waived during the public health emergency, along with other regulatory flexibilities implemented, to determine if they would promote economic recovery if they were made permanent.
More than 500 doctors from throughout the U.S. wrote to Trump Tuesday raising an alarm over the “exponentially growing negative health consequences” of the national shutdown aimed at flattening the spread of COVID-19. “In medical terms, the shutdown was a mass casualty incident” that goes beyond coronavirus infections, according to the letter. As a result of delaying elective and routine medical procedures during the shutdown, 150,000 Americans per month have missed having a new cancer detected through routine screening and millions have missed routine dental care to fix problems strongly linked to heart disease and preventable cases of stroke, heart attack and child abuse, the doctors said, adding that “suicide hotline phone calls have increased 600%.” The letter referenced specific patients whose health deteriorated because of the shutdown, including a nursing home patient who had been expected to make a nearly complete recovery after suffering a stroke in early March. But since the shutdown, he has had no physical or speech therapy, has lost weight and is deteriorating rather than improving. “It is impossible to overstate the short, medium and long-term harm to people’s health with a continued shutdown,” the doctors said. They urged the Trump administration not to overlook the downstream health effects, which have been “massively under-estimated and under-reported.”
The FDA posted a warning letter Tuesday to International Trading Pharmaceuticals Laboratories Inc., a Paterson, N.J.-based contract analytical testing laboratory for active pharmaceutical ingredients (APIs). While the letter stemmed from an October 2019 inspection, it referenced issues going back two years earlier. For instance, the letter cited the improper investigation of out-of-specification (OOS) results from October 2017. It also noted that the lab conducted assay and identity A testing on multiple API samples following U.S. Pharmacopeia (USP) methods without verifying their suitability under actual conditions of use. When the lab responded that it verified all testing methods under actual conditions by meeting system suitability requirements, the FDA said, “System suitability is not a substitute for method verification.” The agency reminded the lab that it had had to change the flow rate to achieve proper peak separation for certain USP samples as part of an OOS investigation, despite passing system suitability results. During the inspection, the FDA investigator also observed that computers used to run high performance liquid chromatography and gas chromatography tests allowed analysts to delete raw data files and alter the date and time stamps. Since audit trails weren’t enabled, there was no way to determine whether the data had been manipulated.