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.
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.
Running a Restaurant in the Covid Era; So Much Regulation, So Little Guidance.
Americans miss dining out. In fact, surveys indicate that sitting down in a restaurant is the most missed pastime of the Covid-19 pandemic. As the monotony of homebound living grows and already economically fragile restaurants operate at a diminished capacity, patrons and restaurants alike are flouting regulations to get back to normal. Between the pressure of dwindling stimulus loans and eager customers, regulation must be balanced with economic relief to encourage responsible and sustainable reopening.
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.
Telehealth Services Amid a Global Pandemic
With COVID-19 rapidly spreading, telehealth services have been seeing an explosion of demand. On March 17, 2020, President Trump announced during a White House press briefing an unprecedented expansion of telehealth services for the 62 million Medicare beneficiaries who are amongst the most vulnerable to the disease. The Department of Health and Human Services (“HHS”) and Centers for Medicare and Medicaid Services (“CMS”) have since vowed to work with the administration by temporarily relaxing certain HIPAA, altering licensure, cost-sharing, and auditing requirements. As the number of patients increases, compliance and privacy risks associated with telehealth also surge.
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.
As CBD Sales Grow, FTC Cautions Against Misrepresentations
On September 10, 2019 the Federal Trade Commission (FTC) sent warning letters to three companies that sell oils, tinctures, capsules, “gummies,” and creams containing cannabidiol (CBD) regarding the companies’ false advertising practices. Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). CBD does not cause intoxication like THC.
The FDCA and Cosmetics Enforcement: Better Late than Never
In March 2019, the FDA issued a statement explaining that asbestos was found in certain cosmetic products sold at retail stores Claire’s and Justice. The Food, Drug, and Cosmetics Act (FDCA) has always granted the FDA similar authority to monitor cosmetic products for adulteration or misbranding as it does food. However, litigation in this area was notably silent. The FDA’s change in position on its authority is long overdue.
How Will Recreational Marijuana Impact Illinois?
During Governor-elect J.B. Pritzker’s election campaign, he heavily advocated for Illinois to be more accommodating to recreational marijuana usage. In Illinois, medical marijuana has already been legalized, and new bills are being introduced to make it more accessible. If recreational marijuana is legalized, Illinois will join ten states, and the District of Colombia, in its authorization.