In the United States, “The Big Five” denote the largest five publishing houses. These publishing empires print everything from medical textbooks to children’s books and together control over eighty percent of the publishing market. The Big Five includes Penguin Random House, HarperCollins, Simon & Schuster, Hachette, and Macmillan. In November of 2020, Viacom announced the sale of Simon & Schuster to Penguin Random House for $2.175 billion. A year later on November 2, 2021, the U.S. Department of Justice announced a lawsuit challenging the acquisition to ensure “fair competition in the U.S. publishing industry.”
Price Control Legislation for Generic Drugs – A Delaware Case Study Andrew Thompson Associate Editor Loyola University Chicago School of Law, JD 2023 Earlier, I wrote here about how American drug prices are approximately 256 to 344 percent higher than prices in OCED member markets. Federal legislators confronting patent extensions, pay-for-delay agreements, and other tools …
The process of the criminal trial of the youngest woman self-made billionaire, has recently started up again after being stalled due to Covid restrictions in the past year. Former CEO and founder of Theranos, Elizabeth Holmes, and her former president and one-time boyfriend, Ramesh Balwani, have been accused of misleading investors and raising hundreds of millions of dollars by making false or exaggerated claims in defiance of the anti-fraud provisions of federal securities laws. While she is currently facing a federal indictment on twelve different charges, including two counts of conspiracy to commit wire fraud and ten counts of wire fraud, Holmes has already settled her civil charges, which were brought forth by the Securities Exchange Commission (SEC). The civil charges brought forth by the SEC have now put Silicon Valley on alert by ensuring that technology companies who claim that they have a new groundbreaking technology that can change the world must be based on factual evidence, not purely myths.
Recently, whistleblower Frances Haugen testified before a Senate subcommittee that Facebook has been deliberately putting its own profits before users’ safety. As Facebook’s former product manager for civic misinformation, Haugen calls for federal regulation of social media platforms and asserts that Facebook will not solve what she calls a “crisis” of deliberately ignoring users’ wellbeing for the sake of its own profits without Congress’s help. She points to tobacco, automobiles, and opioids, stating that when it became clear that those products were harming people, the government took action.
Recently, pharmaceutical companies are gaining increased notoriety for violations of the False Claims Act, the Anti-Kickback Statute, and general fraudulent practices directed toward physicians and medical care providers with the intent to increase profits. In 2019, Avanir Pharmaceuticals settled with the Department of Justice to pay more than $108 million of criminal penalties and civil damages for engaging in kickbacks with physicians, and misleading marketing of their drug Nudexta for unapproved purposes. Then, in May of 2021, Incyte Corp., a Delaware-based pharmaceutical manufacturer agreed to pay $12.6 million for unspecified damages arising under a violation of the Federal False Claims Act for improperly using an independent foundation to cover copays of individuals consuming Incyte’s cancer drug, Jakafi. Despite widespread prosecutions against pharmaceutical drug manufacturers, and the fraud deterrent provisions of the False Claims Act, the risk of fraud and remuneration still runs high in relationships between healthcare professionals and pharmaceutical companies.
The Food and Drug Administration (FDA) has partnered with the Patent and Trademark Office (USPTO) to address the high cost of prescription drugs. While the FDA possesses the authority to approve generic, lower cost drugs, the USPTO has an important and symbiotic role in bringing affordable drugs to market by blocking anti-competitive patent extensions. FDA-USPTO collaboration has gained congressional support and is the subject of key pieces of new legislation.
On June 29, 2021, Illinois Governor J.B. Pritzker signed a bill into law that allows collegiate student-athletes to hire agents and sign endorsement deals effective as of July 1, 2021. This bill puts Illinois among a number of states which have begun to pass legislation allowing student-athletes to receive payment for the use of their name, image, and likeness (“NIL”). While these laws open opportunities for student-athletes, they also present several potential challenges to the NCAA, the governing body for collegiate athletics in the United States, and its member institutions barring any Congressional assistance.
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.
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.
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.