The debated use of chloroquine antimalarial drugs for COVID-19 continues to make global headlines this week. Rick Bright, who’s served as director of the U.S. Biomedical Advanced Research and Development Authority (BARDA) since the Obama administration in 2016, blamed his ouster from the post this week on his refusal to endorse the broad use of hydroxychloroquine and chloroquine in the pandemic. “While I am prepared to look at all options and to think ‘outside the box’ for effective treatments, I rightly resisted efforts to provide an unproven drug on demand to the American public. I insisted that these drugs be provided only to hospitalized patients with confirmed COVID-19 while under the supervision of a physician,” Bright said Wednesday. “These drugs have potentially serious risks associated with them, including increased mortality observed in some recent studies in patients with COVID-19.” Bright has been reassigned to the NIH where he will be involved in developing diagnostics. Bright said he will ask the Health and Human Services Office of Inspector General to “investigate the manner in which this administration has politicized the work of BARDA and has pressured me and other conscientious scientists to fund companies with political connections as well as efforts that lack scientific merit. Rushing blindly towards unproven drugs can be disastrous and result in countless more deaths.”
The COVID-19 EMA Pandemic Task Force issued a public health statement Thursday reminding doctors that chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems. The task force advised doctors to closely monitor patients with COVID-19 who are being treated with one of the antimalarials and to take into account pre-existing heart problems that can make patients more prone to arrhythmia. Doctors should consider the possibility of side effects, particularly with higher doses of the drugs, and use extra caution when combining treatment with other medicines, such as the antibiotic azithromycin, that may cause similar heart problems. Since the drugs are being used off-label, the safety and efficacy data of the chloroquines against COVID-19 is still limited and inconclusive. The drugs are being tested in several large randomized trials, often at higher doses than that approved for their labeled uses in malaria, lupus and rheumatoid arthritis. The EMA said it has enhanced its safety monitoring of drugs used to treat COVID-19 so it can take timely action when necessary. Chloroquine and hydroxychloroquine should only be used as a COVID-19 treatment in the EU as part of clinical trials or in line with nationally agreed protocols, the EMA said. They are not to be used without a prescription and supervision by a doctor.
U.S. cybersecurity officials are being asked to take immediate steps to bolster defenses against health care-related cyberattacks following reports that China, Iran, North Korea, Russia and criminal groups are targeting the U.S. health care and medical research sectors with hacking campaigns. The attacks include spying on medical response and research, ransomware attacks aimed at hospitals and disinformation about health related to COVID-19. “Our country’s health care, public health and research sectors are facing an unprecedented and perilous campaign of sophisticated hacking operations from state and criminal actors amid the coronavirus pandemic,” five U.S. senators, from both political parties, said in a letter to the Cybersecurity and Infrastructure Security Agency and the U.S. Cyber Command. During the pandemic, the cybersecurity and digital resilience of the nation’s health care, public health and research sectors “are literally matters of life or death,” as disinformation, disabled computers and disrupted communications due to ransomware, denial of service attacks and intrusions result in critical lost time and diverted resources, according to the senators. The letter cited a report that China’s state-sponsored APT41 hacking group carried out one of the broadest U.S. hacking campaigns from China in recent years, beginning at the onset of the pandemic. Although it was aimed broadly at networking tools such as latest cloud software, the campaign included health care and biopharma companies bracing to respond to the coronavirus.
The FDA’s ongoing suspension of on-site inspections of drug and device manufacturing facilities both at home and abroad due to the coronavirus pandemic is raising flags about the safety and quality of products on the U.S. market. “Given the uncertainty surrounding COVID-19, and broader vulnerabilities this pandemic highlights with regard to the volatility of the U.S. drug and device supply chain, we are concerned about the sustained safety of FDA-regulated products if staff are pulled from inspections for a longer length of time or if this becomes a recurrence,” several Democratic senators wrote this week to FDA Commissioner Stephen Hahn. The letter asked the agency to provide an update on the steps it’s taking to evaluate manufacturing facilities in lieu of on-site inspections.
U.S. Sens. Mark Warner (D-Va.) and Tim Kaine (D-Va.) wrote to FDA Commissioner Stephen Hahn Wednesday, imploring him to do whatever possible to ensure patients with lupus and rheumatoid arthritis (RA) can continue to fill their prescriptions for hydroxychloroquine and chloroquine as the demand for the drugs as an off-label COVID-19 treatment outstrips the supply. “Hydroxychloroquine is often the only medication that works to increase survival for lupus patients. Shortages could be especially deadly for minority women, as lupus is the fifth leading cause of death in African American and Hispanic-American women,” the senators wrote. While pharmacies and hospitals have purchased “excessive amounts” of the drug, prescribers have reported that local supplies are depleted. “We fear that if this continues, we will have a new public health crisis on our hands on top of the pandemic,” the senators said.
The FDA issued a guidance on a temporary policy allowing state-licensed pharmacies and federal facilities that are not registered outsourcing facilities to compound certain drugs for hospitalized patients during the COVID-19 public health emergency. “In light of unprecedented disruptions to, and demands on, the global pharmaceutical supply chain as a result of the COVID-19 pandemic, and in order to respond to evolving regional conditions, additional flexibility is temporarily needed to help ensure that treatment options are available when hospitals are unable to obtain FDA-approved drugs used for hospitalized patients with COVID-19,” according to the guidance. Under the temporary policy, the compounded drug must be provided directly to a hospital that is treating COVID-19 patients and that is unable to get adequate supplies of certain FDA-approved drug or drugs compounded at a registered outsourcing facility. The compounded drugs must be labeled with a default by-use-date. State-licensed pharmacies must have state permission before compounding the drugs.
The EMA launched the first phase of its enhanced fast-track monitoring system to help prevent and mitigate supply issues with crucial drugs used for treating patients with COVID-19. In the first phase, each drug company will appoint a single contact point who will report to the EMA and national competent authorities all current and anticipated shortages of drugs in the greatest demand to treat COVID-19 patients in hospital intensive care units, including anesthetics, antibiotics, resuscitation drugs and muscle relaxants. The second phase will broaden the range of COVID-19 treatments subject to the reporting requirements.
The European Commission, EMA and the Heads of Medicines Agencies updated a question-and-answer document on regulatory adaptations to address COVID-19 challenges. For instance, the validity of good manufacturing practice certificates and time-limited manufacturing and import authorizations, as well as the validity of good distribution practice certificates and time-limited wholesale authorizations, will be extended until the end of 2021. Inspections will be carried out remotely, as needed, to support the extensions, with on-site inspections conducted as soon as feasible. The update also discusses adjustments that can be applied to the work of qualified persons, who are responsible for certifying that each drug batch is suitable for release for sale or for use in a clinical trial.
The U.K.’s National Institute for Health and Care Excellence released two new COVID-19 rapid guidelines Thursday. The guideline on gastrointestinal and liver conditions being treated with drugs affecting the immune response advises doctors on how to adjust care to reduce patients’ exposure to COVID-19. It also discusses how to balance the benefits and risks of taking drugs that affect the immune system during the pandemic. The second guideline, on acute myocardial injury, is intended to help providers who are not cardiology specialists identify, monitor and treat heart problems in patients with confirmed or suspected coronavirus infections but with no known history of heart disease. Acute myocardial injury was observed in 9.5% of all hospitalized patients dying in Italy, according to the guideline, and some of the symptoms are similar to those of respiratory complications seen with COVID-19. The guidance also advised that some of the drugs used in COVID-19 trials, including azithromycin and hydroxychloroquine, may lead to arrhythmia.
Drugs newly registered in Australia beginning Jan. 1, 2021, must use the Therapeutic Goods Administration’s (TGA) new consumer medicine information (CMI) template. While previously registered drugs must adopt the new format by Dec. 30, 2025, the TGA is encouraging sponsors to use the new format earlier for the benefit of consumers. Developed in response to concerns about the complexity and readability of CMIs, the new template is shorter, better laid out and features a one-page summary that provides the most critical information about a drug at a glance, according to the TGA.
Republican lawmakers are urging leadership in both the U.S. House and Senate to ensure that no COVID-19 relief funding is sent, directly or indirectly, to China’s Wuhan Institute of Virology. Spurred by reports that the NIH for years has been funding coronavirus-infected bat research at the laboratory, nearly 50 members of the House and five senators signed a letter this week calling for an end to taxpayer funding of a “Chinese state-run bio-agent laboratory that lacks any meaningful oversight from U.S. authorities.” The letter also cited a new report indicating that U.S. State Department cables from 2018 warned of “a SARS-like pandemic” risk related to the lab’s coronavirus research on bats.