Following Guidelines During a Crisis

The guidance states, "These preventative measures can include steps to prepare personnel such as: * "Educating employees on topics such as, in the case of a pandemic, personal hygiene (hand washing and coughing and sneezing etiquette), social distancing, and appropriate use of sick leave * "Encouraging employees to get immunized as appropriate by providing information on local vaccination services or by offering on-site vaccination services, if reasonable * "Providing information for and encouraging employees to develop family emergency preparedness plans * "Reviewing CGMP [current good manufacturing practice] regulations regarding appropriate sanitation practices and restriction of ill or sick employees from production areas (see 21 CFR [Code of Federal Regulations] 211.28)" (2). Examples include: * "Production equipment routine maintenance * "Utility system performance checks and maintenance (e.g., air temperature, lighting, compressed air) * "Environmental monitoring of facilities such as cell culture, harvesting, and purification rooms during production * "Stability testing for certain drug products and components * "Periodic examinations of data and of reserve samples" (2). EMA, Guidance on the Format of the Risk Management Plan (RMP) in the EU-in Integrated Format, EMA/164014/2018 Rev.2.0.1 accompanying GVP Module V Rev.2 Human Medicines Evaluation (EMA, 31 October 2018).

Analysis: FDA's COVID-19 Accelerated Pathways

Current FDA programs to accelerate access In order to accelerate the product approval process, four regulatory programs currently exist to reduce development and review times for products that address unmet medical needs for the treatment of serious or life-threatening conditions. In May 2014, FDA issued a Final Guidance for Industry entitled, "Expedited Programs for Serious Conditions-Drugs and Biologics" which addresses fast track designation, breakthrough therapy designation, priority review designation and accelerated approval.3 In addition to this guidance document, under section 564 of the FD&C Act, 21 U.S.C. 360bbb3, in a situation where the Secretary of Health and Human Services (HHS) issues a declaration of emergency or threat justifying authorization of emergency use for a product caused by chemical, biological, radiological or nuclear (CBRN) agents, as well as an infectious disease, the Commissioner of the FDA may authorize an EUA of an unapproved product or an unapproved use of an approved product. In January 2017, the "Emergency Use Authorization of Medical Products and Related Authorities" guidance was finalized.4 Fast Track designation Section 112 of the Food and Drug Administration Modernization Act of 1997 (FDAMA), entitled "Expediting Study and Approval of Fast Track Drugs," mandates the facilitation of the development and processes to expedite review of therapeutics intended to treat serious or life-threatening conditions presenting with unmet medical needs. [...]a two-tiered system of review times, Standard Review and Priority Review was created.

Driving Consistency in Validation Management

FDA also explained that system designs and controls should allow for detecting errors, omissions, and unusual results-outcomes that cannot be easily identified with paper-based processes. Because the guidance requirements for record retention and review don't differ between paper or electronic, this update supports the shift to a digital model. Using paper to check and mark things off is a normal practice in life sciences, even if it is not a very good process for error detection, data collection, or metrics, says Bryony Borneo, quality assurance director at global contract research organization (CRO) Emmes. Building a solid data foundation and gaining more experience with remote ways of working are driving positive change and making it easier for quality teams to remain compliant with regulations. According to Sanjeev Kumar, senior director, data integrity and technology at Vertex Pharmaceuticals, there is greater awareness of data standardization to identify developing trends and insights from information.

Resuming Operations During a Pandemic

FDA therefore requests that, "A drug manufacturer whose manufacturing operations have been disrupted by the COVID-19 public health emergency should follow an established plan, which includes returning to normal CGMP operations, with consideration given to when there is a reasonable expectation that normal operations will be maintainable for an extended period of time" [emphasis added by author] (1). FDA requests that in these circumstances drug manufacturers perform the following (1): * Identify these deviations and any necessary remediation actions. * Evaluate these actions as part of their risk management approach. * Prioritize resumption activities based on the results of the evaluation. [...]activities include, for example, critical quality attribute testing, investigations of critical deviations, and evaluation of unapproved changes to critical operations or materials.

Dietary supplements' knowledge, attitude and consumption pattern among United Arab Emirates population

PurposeTo study the consumption pattern, attitude and knowledge of the general population about dietary supplements (DS) in the United Arab Emirates (UAE).Design/methodology/approachA community-based cross-sectional study was conducted to collect data on knowledge, attitude and consumption pattern related to the use of DS. Participants aged = 18 years were asked to complete a self-administered online questionnaire that included demographic characteristics, health and lifestyle information, consumption patterns, attitudes and knowledge levels regarding the use of DS.FindingsA total of 207 individuals participated in the study, and 117 (56.5%) participants reported using DS products as influenced by the pandemic of coronavirus disease 2019 (COVID-19), of which 63 (53.8%) participants had been using DS for more than one month but less than one year. The majority of the participants was females (64.7%), non-UAE nationals (60.9%) and employed (51.7%). Multivitamins (77.8%) were the most commonly used DS. Use of DS was more prevalent among older participants (n = 78 (61.9%), p = 0.006), non-UAE nationals (n = 79 (62.7%), p = 0.025) and employed (n = 69 (64.5%), p = 0.023). Improving general health (76.1%) and immune booster (47%) were the most frequently identified reasons for using DS, which is relatable to the COVID-19 pandemic. The majority of study participants (72.12%) reported knowing relatively little about the use of DS. About 154 participants (74.4%) did not know that DS products do not treat diseases.Research limitations/implicationsFurther studies with a larger sample size need to be conducted to examine the association between gender or chronic disease and the consumption and type of DS products used to fill the gap in the literature and overcome the limitations identified in this study.Originality/valueThis study highlights the need for community education programs and strategies that can raise awareness of the health benefits and risks of using DS. Further studies with a larger sample size need to be conducted to examine the association between gender or chronic disease and the consumption and type of DS products used to fill the gap in the literature and overcome the limitations identified in this study.

Payer Strategies to Ensure Access to Care for Individuals With Opioid Use Disorder During COVID-19

[...]increase access to care by reimbursing virtual visits. [...]leverage data to identify and intervene when patients are at risk for recurrence or overdose. In practice, expanded access to buprenorphine reduces diversion and misuse because they occur commonly among individuals seeking relief from withdrawal.2 Compared with buprenorphine monotherapy, buprenorphine-naloxone is associated with lower rates of misuse.2 Mark et al demonstrate that among Medicare beneficiaries, removal of prior authorization for buprenorphine-naloxone doubled treatment rates and significantly reduced emergency department (ED) visits and hospitalizations.4 Ultimately, the lifesaving benefits of expanded access to buprenorphine far outweigh the associated risks. In a time of social distancing, limited personal protective equipment, and transportation barriers, payment and delivery of telehealth is imperative to ensuring access to care. Because many patients do not have reliable access to broadband connection or smartphones, audio-only visits must be reimbursed as well.

Vaccine development

The Center for Biologics Evaluation and Research, established by the FDA in 1987, has rigorously evaluated the use of vaccines in the United States for the past 35 years.1,2 The details of vaccine evaluation are well documented in the Code of Federal Regulations (Title 21), and FDA guidance documents that form the "Bible" for vaccine manufacturers (known as sponsors) to follow.3 The guiding principles for vaccine evaluation can be summed up in 3 words-safety, efficacy, and quality. Vaccine development first begins in the laboratory, where the goal of basic research is to understand the complex interactions between pathogens and their human hosts and to generate the knowledge and technology essential for developing a vaccine candidate.5 In advancing the development of a vaccine candidate, scientists build on the extensive research accumulated from the development of more than 80 vaccines currently licensed in the United States and elsewhere while also accessing new technological advances, including improvements in adjuvants and the development of mRNA technology, used in several COVID-19 vaccines.6-8 Preclinical testing in nonhumans Before any vaccine is tested in humans, preclinical research, involving animal studies (eg, with rodents or nonhuman primates) and/or in vitro testing is required. All human studies are required to be conducted under Good Clinical Practice (GCP) regulations established by the FDA as well as the Declaration of Helsinki, a statement of ethical principles for medical research first written in 1964.11,12 The safety and human rights of study participants are rigorously enforced in every clinical trial through well-defined processes for informed consent, study oversight, and protection of privacy. Most vaccines have been required to have a prelicensure safety database of at least 3000 participants vaccinated with the dosing regimen intended for licensure.13 Assessment of safety in 3000 individuals allows for a 95% chance of detecting the occurrence of more common adverse events in 1 in 1000 participants (the "rule of 3").14 The COVID-19 trials for mRNA vacci nes for adults were considerably larger (> 15,000 and > 13,000 vaccine recipients followed for safety);subsequent studies to authorize use in children aged 6 months to 4 to 5 years involved several thousand children followed for a median of 2 months.7,8,15,16 Clinical trials for other vaccines have included safet y data on more than 5900 infants for the pen-tavalent DTaP, IPV, Hib-combina-tion vaccine, more than 7000 infants and toddlers for 3 pneumococcal conjugate vaccines, and more than 15,000 children and young adults (8-26 years) for 3 HPV vaccines.17-19 The FDA may request a larger safety database if a possible safety signal is identified or in response to new information from other vaccines.

Biting the Bullet: A Call for Action on Lead-Contaminated Meat in Food Banks

Even though the presence of ammunition-derived metallic lead fragments in donated firearms-hunted meat has been recognized for more than a decade, the vast majority of donated hunted meat is not inspected to discard meat containing lead fragments.1 An underlying lack of food safety standards for adulterated donated food increases risks to lowincome recipients, who are already disproportionately affected by elevated blood lead levels (BLLs).2 Primary prevention is needed for this overlooked source of lead exposure. LOW-LEVEL LEAD Primary prevention is recognized as the most effective way to address the epidemic of lead poisoning in the United States.3 The current blood lead reference level recognized by the Centers for Disease Control and Prevention is 3.5 micrograms per deciliter (mg/dL). A strong body of scientific research demonstrates that leadbased ammunition frequently contaminates hunted meat and increases BLLs of humans and animals who consume it.1,7-9 Lead-contaminated hunted meat has been identified as the most poorly acknowledged and addressed example of food lead contamination, and scientists have called for this source of lead exposure to be acknowledged and addressed with health-protective measures.8,9 A 2013 consensus statement of experts in human, environmental, and wildlife toxicology supports reducing and eventually eliminating the introduction of lead into the environment from lead-based ammunition, emphasizing that shooting lead ammunition into the environment poses significant risks of lead exposure to humans and wildlife.10 In 2016, Arnemo et al. found that more than 99% of 570 scientific articles about environmental and health consequences of lead in ammunition raised concerns about lead toxicity.7 The authors highlighted that nonlead ammunition is as effective as lead-based ammunition and is comparably priced. Despite the well-established scientific basis for regulation of lead ammunition for hunting, the topic has been politicized by misinformation campaigns portraying concerns about ingesting lead ammunition as a product of antihunting agendas.11 Lead Contamination in Donated Hunted Meat Donated hunted meat is a vital source of protein distributed by food banks at a time when food bank use remains far above pre-COVID-19 pandemic levels.12 Published evidence of leadcontaminated meat in food banks has existed for more than a decade (Figure A, available as a supplement to the online version of this article at https://www.ajph.org).13 Investigations in multiple states have confirmed the presence of lead in donated meat.

The Epidemic During the Pandemic: Assessing the Federal Drug Administration's Efforts to Curb Youth Smoking After Passage of HR2339 by Congress

The act sought to improve Food and Drug Administration (FDA) regulation ofthe marketing, sale, makeup, safety, and study of electronic nicotine delivery systems (ENDSs). Since the passage ofthe act, the United States has made some progress in limiting youth access to flavored ENDSs. Factors influencing youth tobacco use included flavoring in tobacco products, product marketing and access, and misconceptions about health risks.5 Studies also show that tobacco industry profits from the sale of ENDSs have increased since the passage of HR2339 and through the COVID-19 pandemic. Public health advocates must quickly respond to tobacco industry marketing tactics by debunking misleading campaigns promoting new synthetic nicotine and "tobacco-free" products attempting to circumvent regulation.8 Along with increases in taxes on ENDSs and enactment of policies restricting the sale of flavored products at the local level, such actions can help protect young people from the harms caused by tobacco products and help discourage them from ever starting at all. ,4jPH CORRESPONDENCE Correspondence should be sent to Michael D. Celestin Jr, PhD, NCTTS, CHES, Behavioral and Community Health Sciences Program, School of Public Health, Louisiana State University Health Sciences Center New Orleans, 2020 Gravier St, 3rd Floor, New Orleans, LA 70112 (e-mail: mceles@lsuhsc.edu).