Tag:CDC
CDC/ED Guidelines for Reopening Schools: Does This End the Debate?
For almost a year, schools have been reacting to the unprecedented circumstances that Covid-19 has caused. Most of the mitigation efforts thus far have been at the direction of state and local governments. Only recently have federal agencies given clear and substantial guidance on how to get students back into the classroom. Schools have largely fallen into three categories — in-person, remote, or a blended model that involves students doing some classwork at home and some at school. Some schools moved to increase their in-person learning and some have had to retrace their steps when positivity rates were too high, either in the school or in the larger community.
#WFH – Fad or the Future?
There seems to be no end in sight to the various concerns associated with COVID-19, and experts are hesitant to say when and if life as we knew it will ever return to “normal.” As the pandemic persisted, companies large and small quickly realized that jobs we all assumed had to be done in an office, can in fact be done from the comfort of one’s home. #WFH is a trending social media hashtag standing for “work from home,” and posts using this hashtag range anywhere from how to dress comfortably while remaining professional when working from home to setting up the perfect home office. #WFH, however, is not just a social media trend, but a new normal for many Americans as employers were forced to allow their employees to work from home due to health concerns related to COVID-19. This gives rise to questions such as, what about safety and security concerns related to employer data? And, where do employees draw the line between work and home when working from home? While this may be uncharted territory, top researchers say that #WFH may be the next big thing for companies worldwide.
Skewed Success: Self-Regulation of Artificial Reproductive Technology in the US
In the United States, Assisted Reproductive Technology (ART) is predominantly self-regulated by a network of medical agencies that publish guidelines. ART refers generally to any fertility procedure where eggs or embryos are handled. ART clinics are not federally funded, and there is no specific national legislation that establishes a clear regulatory framework about the standard of operations, the quality-of-care patients should be provided with, the permissible uses of ART, or recourse for patients who have not benefited from their financial investments in ART. There are minimum standards set forth by the Food and Drug Administration (FDA) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which require strict compliance before patients can consult and use clinics’ ART services including the use of pharmaceutical products. The Federal Trade Commission (FTC) also oversees truthful advertising and marketing practices within ART to ensure that clinics’ reports of success are consistent with their patient data. All states require that physicians obtain a license before providing care, and physicians are subject to investigation by state boards. Aside from this general regulation for safety and transparency, the only explicit regulation targeting the ART industry is the United States Fertility Clinic Success Rate and Certification Act, mandating all US fertility clinics to report their ART cycles performed to the Center for Disease Control (CDC). The data collected through this reporting act is governed by the NASS 2.0 (National Assisted Reproductive Technology Surveillance System), which is a collaborative surveillance system between the CDC, and private stakeholders. Self-reported data to NASS 2.0 is verified by comparing information from a patient’s medical record with data submitted for the report.
Exploring COVID-19 Vaccine Authorization by the FDA
As of April 22, 2021, 218,947,643 million people have received the COVID-19 vaccine. Before or during the appointment, your provider directs you to a fact sheet for the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine. On the fact sheet, there were a couple of sentences that caught my eye “The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (“FDA”) approved vaccine to prevent COVID-19.” When I read this, I wanted more information about the difference is between being authorized or approved. Like many people, one can become hesitant when a product is not adequately tested; in fact, a Kaiser research project shows about 30% of people probably or definitely not get the vaccine.
Nursing Home Staff Turnover Rates Partially Explains Disproportionate Number of Deaths during COVID-19 Public Health Emergency
The COVID-19 pandemic has impacted residents and staff of nursing homes and long-term care facilities more than any other demographic, accounting for nearly 40 percent of the total mortality rate from the virus in the United States. According to Centers for Medicare & Medicaid Services (“CMS”), at least 132,000 residents and employees have died from complications of the COVID-19 across 31,000 facilities, although some estimates place the death count closer to 200,000. One factor aggravating the number of deaths in nursing homes is the extraordinarily high rate of staff turnover each year.
New CDC Guidelines for K-12 Schools May Send More Students Back to Classrooms
Recently, the Centers for Disease Control and Prevention (“CDC”) released revised guidelines regarding physical distancing in K-12 schools. Originally, the CDC recommended that students should stay six feet away from each other in a classroom with mask but now recommends at least three feet between students in classrooms. These new guidelines will encourage more schools to return to the classroom around the nation.
The Food Safety Modernization Act is Just the Beginning of the FDA Compliance We’ve Been Waiting For
Despite the United States having one of the safest food supplies in the world, more than 48 million Americans get sick from foodborne illnesses and diseases each year, and more than 128,000 are hospitalized and 3,000 die from similar issues that are largely preventable. On January 04, 2011 President Obama signed the Food Safety Modernization Act (“FSMA”) into law. This enactment was called the “most sweeping reform” of U.S. Food Safety laws in more than seventy years. But seven years later, the act is still only partially enforced as the FDA has faced resistance from the government as well as a lack of funding. The FMSA was and is intended to enable the FDA to protect the health of the public by strengthening the food system in the United States. While change and reform in the industry are necessary, what good are new reforms if they will not be enforced for years to come?
FDA Finalizes Enforcement Policy Against Vaping
Amid the epidemic levels of youth use of e-cigarettes, the U.S. Food and Drug Administration, released a policy on January 2, 2020, requiring enforcement against certain unauthorized flavored e-cigarette products that appeal to kids. According to the policy, the FDA intends to prioritize enforcement against fruit and mint flavored, cartridge-based electronic nicotine delivery system (“ENDS”). The FDA looks to regulate all ENDS products that manufactures have failed to make safe for use, as well as any ENDS product marketed for use by minors. The 2019 National Youth Tobacco Survey (“NYTS”), a survey conducted annually by the FDA in conjunction with the Centers for Disease Control and Prevention, shows approximately 1.6 million youths were using ENDS products frequently, with nearly one million using e-cigarettes daily. The FDA’s enforcement policy is not a “ban” on flavored cartridges. If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considerations on how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.
CMS Issues New Rigid COVID-19 Requirements for Skilled Nursing Facilities
The Centers for Medicare & Medicaid Services (“CMS”) released new guidance for skilled nursing facilities (“SNFs”) as part of a larger rulemaking agenda for healthcare institutions in the throes of the current public health emergency with COVID-19. CMS has also detailed the fines for non-compliance with the new COVID-19 requirements for SNFs and other healthcare institutions such as hospitals and laboratories.
Workplaces and Regulations During a Public Health Crisis
The U.S. Department of Labor’s Wage and Hour Division (“WHD”) recently announced alterations to its previous regulations which expanded family and medical leave provisions and paid sick leave of April’s Families First Coronavirus Response Act (“FFCRA”). These revisions serve to clarify the responsibilities of employers and the rights of workers as they relate to the paid leave of FFCRA. These revisions come after a decision from the U.S. District Court for the Southern District of New York which invalidated portions of the initial regulations. The WHD’s revisions are an example of the lack of clarity and adequate response from regulations designed to protect workers during the current pandemic.