INSIDE COMPLIANCE

The New Hope and Frustration for Alzheimer’s Patients

September 13, 2021Krista SolanoDrugs & Devices

For the first time in about twenty years, the U.S. Food and Drug Administration (FDA) approved a drug to combat the progression of Alzheimer’s. The newly approved drug is manufactured by Biogen and will be called Aduhelm. The FDA granted fast track designation of the drug to speed up access to patients. While Aduhelm will not reverse already developed Alzheimer’s symptoms, it will slow down the advancement of the disease by removing deposits of beta-amyloid, a protein found in early-stage Alzheimer’s patient’s brains.

Alzheimer'sDrugsFDAhealthcare

The SPAC Faces Its First Regulatory Obstacle

September 13, 2021Jeffrey HymenFinance & Banking

As Coronavirus (Covid-19) has slowed the global economy, business owners have been forced to adapt to volatile market conditions and use creativity to raise capital. Investors and financial industry professionals have turned their attention to Special Purpose Acquisition Companies (SPACs), which have already raised nearly $100 billion in 2021 compared to $83.4 billion during the previous year. A SPAC is a publicly-traded shell company formed by industry professionals such as institutional investors, private equity firms, and hedge funds. Then, SPAC sponsors will seek to complete a merger or acquisition with another private company, which enables the private company to become publicly traded and bypass the initial public offering (IPO) stage. SPACs usually are allowed two years from the IPO date to formalize an acquisition or return the funds to investors.

financeIPOM&ARegulationSEC

Navigating the Return to the Workplace and the ADA

September 10, 2021Micaela EngerUncategorized

Despite the recent surge in COVID-19 cases, many Americans are still returning to the office. Kastle Systems, a large security services provider, reported that an average of 32.1 percent of employees across ten big cities were returning to work as of August 11, 2021. On August 23, 2021, the Food and Drug Administration (“FDA”) granted full approval to Pfizer/BioNTech’s COVID-19 vaccine. Polls have shown that the FDA approval will lead to an increase in vaccinations. While many people are not going back to the office, most Americans do have plans to return to work. As a result, employers are working to create return-to-work plans, while employees are left wondering about the extent of their rights. The Americans with Disabilities Act (“ADA”) covers employers with 15 or more employees, including government employers, agencies, and labor organizations. The ADA imposes restrictions on the amount and type of medical information that an employer may obtain from an employee or applicant in order to prevent discrimination on the basis of a disability. The ADA has been dissected to better understand the regulations that govern the return to the workplace.

ADACOVID-19EmploymentEmployment Law

Monopoly Defined: Amazon Can Pass Go

September 10, 2021Puja ValeraUncategorized

With the recent antitrust lawsuit filed against Amazon and the new antitrust bills being debated in Congress, the online retail giant is at the forefront of everyone’s mind. The behemoth of a company has entered numerous markets including apparel, technology, and even grocery. The size and scope of the company begs the question, is Amazon a monopoly? As the law stands right now, Amazon is decidedly not.

amazonAntitrustMonopolyRegulation

A Penny for Your Thoughts and a Billion Dollars for My Medication

September 9, 2021Andrew ThompsonDrugs & Devices

As you read this, you’re most likely using a phone or laptop that carries a few patents. A patent is awarded to a person or company in order to protect their intellectual property. Protection of intellectual property rests on the idea that one should be compensated for the time and effort required to produce the patented medium, while others should not be able to profit from the work of another. The patents awarded to your phone or laptop manufacturer allow them recoup research and development expenses and remain competitive against competition. However, the patent system can be abused through patent evergreening and patent thicketing. Evergreening is the practice of obtaining a secondary patent on a slightly modified version of the original patented medium. Thicketing protects the patented medium by creating a web of overlapping or interdependent patents. Recent legislation aims to empower the FDA to decline patent extensions when the slightly modified version of a drug does not yield a clinical benefit.

drug lawenantiomersFDAgenericspatents

The Clean Water Act Revisited: First Application of the County of Maui v. Hawaii’ Wildlife Fund Test Favors Strong Regulation of Water Pollution

August 18, 2021Daniel BourgaultUncategorized

Daniel Bourgault Senior Editor Loyola University of Chicago School of Law, JD 2022 On July 15, 2021, the Hawaii’ federal district court became the first court to publish an opinion utilizing the functional equivalent analysis (“FEA”) established by the Supreme Court of the United States last year in the County of Maui v. Hawaii’ Wildlife …
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clean water actEnvironmental Lawenvironmental regulationJournal of Regulatory ComplianceNPDES PermitRegulation

Stronger Health Regulations in the Fracking Industry Benefit the Industry and Workers Alike

April 30, 2021Daniel BourgaultUncategorized

As a compliance deadline set by the Occupational Safety and Health Administration (“OSHA”) for the fracking industry approaches on June 23, 2021, both the industry and the workers employed by it are seeing benefits. Created by the Occupational Safety and Health Act, OSHA sets out regulations meant to protect employees from work conditions that threaten their health and monitors and enforces compliance with those standards.

Energyenvironmental regulationfrackingJournal of Regulatory ComplianceOSHARegulation

Exploring COVID-19 Vaccine Authorization by the FDA

April 26, 2021Perri Nena SmithDrugs & Devices

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.

CDCCOVID-19FDAFDA approvedFDA authorizedFDA regulationsJ&J vaccineJohnson and Johnson/JanssenJournal of Regulatory ComplianceModerna COVID-19 VaccinePfizer-BioNTech COVID-19 VaccineRegulationVaccineVaccines

The Votes Are In . . . or Are They?

April 22, 2021Sarah RyanUncategorized

On Friday, April 9th, Amazon successfully withstood the largest push for unionization yet for its U.S. workers when its Bessemer, Ala. warehouse employees voted ‘no’ to unionizing. The final tally of ballots showed only 738 votes in favor of joining the Retail, Wholesale and Department Store Union (“RWDSU”) compared to 1,798 votes against it. After a tally, any party may file objections to the conduct of the election or to conduct affecting the election’s results—and the RWDSU is doing just that.

Employment

COVID-19 Vaccine Passports and Privacy Concerns

April 22, 2021Marcella SlayUncategorized

As businesses begin to reopen and resume operations after the pandemic, there are discussions surrounding possible vaccine passports and the concerns protecting individuals’ personal health information. COVID-19 vaccines are becoming more available within the country and more Americans feel safe to resume their normal lives. Many states and businesses are contemplating the idea of making vaccine passports a requirement for travel and large events. The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) was created to protect personal health information. As other countries are beginning to require proof of vaccination, many are contemplating whether vaccine passports are permitted by HIPAA or if the requirement will actually violate the federal health privacy law.

COVID-19HHSHIPAAPrivacy & Securityprivacy lawsPrivacy RuleRegulationVaccine