FDA: "Assessing the Safety of Products Used for COVID-19" FDA looks at vaccines and then recalls**HAND-SANITIZERS ugh.

This 2022 Report is an ‘evidential’ basis of what was published when. Or further what was ignored despite having good evidence when.

My understanding through going through these reports and others is that the FDA ‘Sentinel’ system may form a basis beyond FAERS for locating adverse events.

Please link direct to the report for many serpentine links to other information.

“COVID-19

The emergence of COVID-19 variants continued to impact the public health worldwide in 2022. FDA worked to address the continuing demand for certain products during the public health emergency, and we remained committed to facilitating access to safe and effective medications to help address critical needs of the American public. The Agency’s safety focus included evaluating medications for emergency use authorization (EUA), taking actions against fraudulent unapproved products for COVID-19, and keeping the public informed. The latest COVID-19 news from FDA can be found here. The following highlights key drug safety actions taken in 2022.

Under section 564 of the Federal Food, Drug & Cosmetic Act, after a declaration by the HHS Secretary based on one of four types of determinations, FDA may authorize an unapproved product or unapproved uses of an approved product for emergency use to diagnose, prevent or treat a serious or life threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent.

Throughout 2022, FDA continued to make weekly updates to the COVID-19 EUA FAERS Public Dashboard to assist the public in searching for information related to adverse events with medications and therapeutic biological products authorized under an Emergency Use Authorization (EUA) during COVID-19. Center for Drug Evaluation and Research, Drug Safety Priorities 2022 3

Medication Shortages

CDER worked to increase patient access to critically needed medications in shortage during the pandemic. This included issuing nine enforcement discretion decisions designed to increase supplies of these needed medications, including dinutuximab, heparin, albuterol, etomidate, midazolam, propofol, contrast agents, cefotaxime, and afamelanotide.

Assessing the Safety of Products Used for COVID-19

To protect the public during the pandemic, CDER monitored and assessed the safety of novel and repurposed medications to treat or prevent COVID-19. We used multiple data sources to conduct surveillance for safety concerns and medication errors related to various products, provided guidance on how to adapt risk evaluation and mitigation strategy (REMS) programs during a pandemic, offered recommendations for labeling to minimize medication errors, and collaborated with other agencies and organizations to study the effects of medications used to treat or prevent COVID-19. The Agency also improved transparency and communication to the public about our review of the scientific information supporting the issuance of EUAs for drug or biological products, and provided timely information for drug companies on developing COVID-19-related treatments.

Surveillance

• Reviewed safety data, including adverse event reports and observational studies, as part of the overall benefit-risk assessment for COVID-19 therapeutics authorized under EUA or approved

LL: the risk benefit is how you override the risk of the therapeutics, assign that benefit as higher or more important.

• Conducted surveillance on case reports in the FDA Adverse Event Reporting System (FAERS) database, medical literature, the National Poison Data System, prescription and nonretail sales, and other data sources; and evaluated newly identified safety concerns and medication errors related to products used to treat or prevent COVID-19

• Reviewed and provided feedback on the quality and feasibility of proposals for real world data (RWD) analyses to help support evaluation of COVID-19 therapies

LL: what is the RWD they obtained?

• Reviewed proprietary names (commonly known as brand names given by the drug companies), container labels, carton labeling, packaging, Fact Sheets, and Dear Health Care Professional letters for COVID-19 therapies

• Created a data-driven, evidence-based approach to monitor and assess signals of medication shortages leveraging CDER’s regulatory tools to ensure patients have continued access to critical COVID-19 medications Center for Drug Evaluation and Research, Drug Safety Priorities 2022 4 Safety Assessment in Population-Based Data Sources

• Examined the use of systemic corticosteroids for COVID-19 in outpatient settings using data from the Sentinel System and three other large U.S. databases, and published the results in the Journal of the American Medical Association (JAMA)1

LL: this Sentinel system is clearly a real find and I look forward to exploring it more. You can too: https://www.sentinelinitiative.org/

• Continued collaboration with the federal Veterans Health Administration (VA) and Centers for Medicare & Medicaid Services (CMS) to develop infrastructure and conduct a near real-time surveillance of EUA products in the CMS Medicare and VA populations

• Utilized FDA’s Sentinel System to perform numerous new and existing activities designed to:

» Describe racial and ethnic distribution of testing, hospitalization, and death from COVID-19; and evaluate associations between race, ethnicity, and COVID-19, and between severe disease and in-hospital death among patients younger than 65 years

» Inform safety surveillance activities by characterizing utilization patterns and baseline characteristics of patients receiving certain EUA products

» Build and enhance infrastructure to analyze health care claims and electronic health record data to support epidemiological studies of COVID-19

» Conduct near real-time monitoring of critical medications in the inpatient setting to assess changes in utilization over time and by geography to inform the potential for medication shortages

» Describe the course of illness among hospitalized COVID-19 patients, including their characteristics, health care utilization, disease progression, and outcomes

» Assess the natural history of arterial and venous thrombotic events, including estimating the incidence of thrombotic events and risk of death following the event, evaluating risk factors for thrombotic events, and comparing risk of thrombotic events among patients with COVID-19 and patients with influenza. Results were published in JAMA.

2

» Examine the natural history of COVID‐19 disease in pregnant women, including medication utilization, disease severity, and clinical outcomes 1 Bradley MC, Perez-Vilar S, Chillarige Y, et al., 2022, Systemic Corticosteroid Use for COVID-19 in US Outpatient Settings from April 2020 to August 2021, JAMA, 327(20):2015–2018.

2 Lo Re V, Dutcher SK, Connolly JG, et al., 2022, Association of COVID-19 vs Influenza with Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients. JAMA. 328(7):637–651. doi:10.1001/ jama.2022.13072

Center for Drug Evaluation and Research, Drug Safety Priorities 2022 5 Collaboration and Communication

• Continued collaboration with the American College of Medical Toxicology (ACMT) to create a Toxicology Investigators Consortium (ToxIC) COVID-19 Sub-Registry, an enhanced data collection tool within the ToxIC network, focusing on identifying potential adverse events related to COVID-19 drug products; and expanded Sub-Registry to include cases reporting new opioid and/or stimulant use, misuse/abuse, overdose, and/or withdrawal possibly related to COVID-19

• Responded to Congressional and media inquiries related to the safety of products used to treat or prevent COVID-19 Emergency Use Authorizations (EUAs) and Approvals FDA continued working to expedite the availability of medications to combat COVID-19 through Emergency Use Authorizations (EUAs). In issuing an EUA, the FDA must determine, among other things, that, based on the totality of scientific evidence available, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent; that the known and potential benefits, when used to treat, diagnose or prevent such disease or condition, outweigh the known and potential risks for the product; and that there are no adequate, approved, and available alternatives. We also approved or expanded the approved indication for the following COVID-19 therapeutics:

Actemra (tocilizumab), Veklury (remdesivir), and Olumiant (baricitinib). Center for Drug Evaluation and Research, Drug Safety Priorities 2022 6

LL: ‘adequate’ clinical trials - not robust.. ‘if available’ aka OR NOT AVAILABLE, ‘reasonable to believe’ like tooth fairy ‘believe’ is not scientifically ‘conclude’ based on EVIDENCE and ROBUST STUDIES” ‘product may be effective’ PRODUCT mAY ALSO NOT BE EFFECTIVE- MAY MEANS NOTHING, ‘OUTWEIGH’ the ‘potential risks’ aka: not even real risks. This is PURE chimera drafting of legalese.

Hand Sanitizer Warnings

LL: this beats all hell. they recalled the Hand Sanitizers.

FDA has remained vigilant throughout the COVID-19 pandemic and continued to take action when safety and quality issues arose with hand sanitizers. We are especially concerned with:

• Products contaminated with harmful or poisonous ingredients such as methanol or 1-propanol. Methanol, also known as wood alcohol, is used to make rocket fuel and antifreeze, and 1-propanol is used to make industrial solvents. Methanol is very toxic, and 1-propanol can also be toxic when swallowed.

• Products contaminated with unacceptable levels of benzene, acetaldehyde, and acetal impurities. Benzene may cause certain types of cancer in humans. Animal studies show acetaldehyde may cause cancer in humans and serious illness or death. Acetal can irritate the upper respiratory tract, eyes, and skin.

• Products contaminated with micro-organisms. Use of contaminated hand sanitizer could lead to serious infections, including of the skin, soft tissues, lungs, and bloodstream. Individuals with compromised immune systems are at increased risk.

• Dangers from drinking any hand sanitizer under any condition. While hand sanitizers with methanol contamination are more life-threatening, FDA urges consumers not to drink any of these products, which are sometimes packaged to appear as drinks, candy, or in liquor bottles and could result in accidental ingestion or encourage ingestion. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal to them.

• Certain hand sanitizers that may not contain sufficient concentrations of ethyl alcohol or isopropyl alcohol. Studies have found that sanitizers with lower concentrations or non-alcohol-based hand sanitizers are not as effective at killing germs as those with 60 percent to 95 percent alcohol.

• Hand sanitizers sold or offered for sale with false, misleading, or unproven claims they can prevent the spread of viruses such as COVID-19, including claims they can provide prolonged protection (e.g., for up to 24 hours)

• Products fraudulently marketed as “FDA-approved” since no hand sanitizers are approved by FDA Center for Drug Evaluation and Research, Drug Safety Priorities 2022 7 We are working to protect the public from poor quality, unsafe, and unapproved hand sanitizer products, in particular those contaminated with methanol. In 2022, the Agency continued to protect consumers by:

• Seeking the voluntary recall of more than 35 hand sanitizer products

• Adding 30 firms to the do-not-use list

• Issuing 31 hand sanitizer warning letters

• Adding 16 firms to Import Alert #66-78 (detention without physical examination of drugs, based on analytic test results) Taking Actions Against Fraudulent Unapproved

Products for COVID-19 FDA has continued to actively monitor for any companies marketing products with fraudulent COVID-19 prevention and treatment claims. We exercised our authority to protect consumers from companies selling unapproved products and making false or misleading claims, including by pursuing warning letters or injunctions against products and companies or individuals that violate the law. Through late October, FDA:

• Issued 20 warning letters to companies marketing products that fraudulently claim to treat COVID-19

• Issued another five warning letters to internet pharmacies unlawfully selling medications claiming to treat COVID-19 Issued Specific Compounded Medication Guidances Related to COVID-19 FDA issued temporary policies via guidances addressing the compounding of certain medications for hospitalized patients during the COVID-19 public health emergency. Human medication compounding is generally a practice in which a licensed pharmacist, a licensed physician, or a person under the supervision of a licensed pharmacist in the case of an outsourcing facility combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient. Compounded medications are not FDA-approved, meaning they have not undergone premarket review for safety, effectiveness, or manufacturing quality.

We recommend FDA-approved medications be used to treat patients whenever possible, reserving compounded medications only for when a patient’s medical needs cannot be met by an FDA-approved medication”

Find the report HERE and you can go through direct links.

2022 Drug Safety Priorities Report 230302

8.8MB ∙ PDF file

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LITERALLY they are laughing at us.

They recalled the Hand Sanitizers.