Category:The Marketplace
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.
Together we go … to the White House?: The Cybersecurity Risks of Peloton
Peloton has a coined the term “together we go far” as their company slogan, and over the course of this year that is exactly what this company has done. Since the company launched in 2012, Peloton has gone far and wide delivering their fitness technology to millions of people across the globe. Peloton is an international company that designs at-home gym equipment and produces virtual workout classes for their customers to live-stream or watch on-demand through their Peloton products. Peloton provides an outlet for fitness and competition while building a positive and inclusive community for their members across the United States and the world. Of the millions of members in the Peloton community, one is our leading man in office President Joe Biden.
COVID-19’s Gender Impact
As March starts and we enter Women’s History Month, Time Magazine, The New York Times, National Public Radio, CNBC, The Washington Post, and more wrote articles on the unique and disproportionate effects that COVID-19 has had on women. However, by focusing exclusively on the effect of COVID-19 on women, we ignore the impacts faced by gender non-binary people. This approach leaves many people to continue to be disproportionately impacted by the pandemic, as economic impacts cannot be addressed and answered, if they are not first acknowledged.
The United States’ current systems and its response to COVID-19 has failed to serve many people, in fact, the pandemic has amplified existing economic and social inequalities. If we are to resolve these inequalities, instead of focusing on the disproportionate effects experienced by cis-gender women, the focus should shift towards marginalized people, such as, cis and transgender women, and non-binary individuals. This article takes a limited approach due to its length, and it focuses on the effects COVID-19 has had on women, and the transgender and non-binary community, where the United States needs to acknowledge the economic inequalities these people face and change the current systems.
Johnson & Johnson COVID-19 Vaccine Awaits Authorization from FDA
Recently, the U.S. Food & Drug Administration (“FDA”) announced a scheduled meeting of its Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) to discuss the request for emergency use authorization (“EUA”) for a COVID-19 vaccine from Janssen Biotech Inc. The FDA has just under three weeks to complete its report before the VRBPAC’s meeting to make its recommendation on the vaccine. The review process may be more challenging than the past two reviews for Pfizer and Moderna due to the composition differences and effectiveness.
Politicizing a Pandemic: Emergency Use Authorizations for COVID-19
The Food and Drug Administration (“FDA”) is one regulatory agency that has been on the forefront of the American fight against COVID-19. Historically, the agency has been highly respected for its success in apolitical operation despite its mission of (1) protecting the public health and (2) innovating in the development of medical products. One of its most important tools in the face of a public health crisis is the once obscure regulatory mechanism called the Emergency Use Authorization (“EUA”). But as public trust in the FDA falters, Americans are surely wondering how effective a protective measure can be when it seems to be used as political ammo.
The War on Drug (Prices)
Prescription medications are one of the most common forms of health care intervention, with approximately sixty-six percent (66%) of adults in the United States using prescription drugs. Prescription drugs can provide major benefits to an individual as well as the general population’s health; if successful, prescription drugs can lead to longer and higher-quality lives. However, as drug prices rise unnecessarily, nearly a fourth of American patients experience difficulty affording their medications. A majority of these patients are people with lower incomes and those who are nearing Medicare age.
The United States has higher drug prices than all other developed nations, where in 2010 the average post-rebate medication price was fifteen percent (15%) higher in the United States than in Canada, France, and Germany. Domestic drug companies argue that the price is due to the cost of research and development, however it is the lack of market regulation by the United States government that allows these exorbitant prices. In response to the outcry against high drug prices, on September 13, 2020, President Trump signed an Executive Order on Lowering Drug Prices by Putting America First. The Order includes a “most favored nations” pricing scheme that includes both Medicare Parts B and D, meaning that Medicare now is able to refuse to pay more for drugs than other developed nations. However, this is not enough. The United States needs to take action at both the state and federal level to ensure that prescription drugs are accessible and affordable to all Americans.
A Joint Venture: Medical Cannabis and Workers’ Compensation
In the long standing and highly regulated field of workers’ compensation, a look into the recent landscape of laws, regulations, and court decisions in New Mexico could provide a snapshot into the rapidly accelerating trajectory of medical cannabis regulation within a state’s workers’ compensation system.
DEA Proposes New Rules Aimed to Increase Federal Cannabis Research
On Monday March 24, the Drug Enforcement Agency (DEA) proposed amending the rules under the Controlled Substance Act to expand cannabis research in accordance with a 2016 policy statement. Among these changes includes directing the DEA to take title and physical possession of cannabis plants and increasing the number of entities permitted to manufacture cannabis for research.
Pre-Approval Access and Pathways to Investigational Drugs
The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 requires pharmaceutical drugs to provide evidence of their safety before they are allowed on the market. As such, pharmaceutical companies submit applications to the Federal Drug Administration for approval. There are situations, however, in which patients seek to receive access to a particular pharmaceutical drug before the FDA approval process is complete. This blog will explore the various pathways to pre-approval access in addition to recent legislation and legal considerations for such pathways, in addition to the principles and common obstacles that pharmaceutical companies face within such pathways.
Establishing Expanded Use Programs
The ability to access experimental drug treatments has long been contentious in the United States. Prior to the 1938 Food, Drug & Cosmetic Act, pharmaceutical drugs were largely unregulated. This Act required, for the first time, that drugs sold to the public were safe. Increasing regulations regarding the marketing, testing, and distribution of pharmaceutical drugs were established throughout the next fifty years. In the 1980s, however, a puzzling illness became known to the public. This illness was called HIV/AIDS, a debilitating virus that caused the body’s own immune system to attack itself. This illness has killed over 32 million people in the United States and worldwide, and particularly impacted the population of gay men. Because homosexuality was still fairly taboo in the 1980s, many argue that the country dragged its foot in researching and approving treatment for HIV/AIDS. Due to significant advocacy, much progress has been made with this particular illness, and the country has slowly evolved from the slow and strict processes that once regulated potential pharmaceutical drug treatments.