Category:The Marketplace
Price Control Legislation for Generic Drugs – A Delaware Case Study
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 …
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The DOJ Challenges Penguin Random House’s Acquisition of Simon & Schuster
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.”
The Story That Sounded Too Good to Be True Was, Indeed, Too Good to Be True.
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.
NCAA Name, Image and Likeness Legislation Raises Concerns
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.
A Case for Regulating Facebook
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.
Talk Kickback to Me: Healthcare Provider Remuneration by Big Pharma
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.
FDA-USPTO Collaboration and Bipartisan Efforts to Lower Drug Prices
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.
FDA’s Proposed Global Regulatory Harmonization for Medical Devices
On February 23, 2022, the Food and Drug Administration (FDA) published a proposed regulation to amend current manufacturing practice requirements of the Quality System Regulation (QSR) (21 CFR Part 820). The FDA first announced such harmonization in 2018, however COVID-19 delayed the proposal. The FDA seeks to align Part 820 more closely with the international specific standard for medical device quality management systems set out by the International Organization for Standardizations (ISO) 13485. According to the FDA, such “harmonization should provide patients more efficient access to necessary devices, leading to improvements of life quality of the consumers.” Part 820 is part of the current mandatory regulations that ensure that all medical devices created and developed within the US market are safe. ISO 13485 is the international standard for a quality management system for medical devices required by certain countries. Therefore, any manufacturer that sells outside the US will likely need to be ISO 13485 certified. With the implementation of this new amendment, manufacturers would be able to assure their products are regulatorily compliant in both the US and international markets.
Decriminalization Is Not Enough, Abolition Is a Must
In the United States, since the 1980s, the federal prison population has increased by roughly 790%. Specifically, presently within Illinois, there are approximately 76,000 citizens who are incarcerated. In 2014, Illinois appropriated and spent nearly $1.3 billion on prison budgets. Where even though cannabis is now legal, in Illinois, roughly 90 inmates are still incarcerated for offenses relating to the use, manufacturing, and selling of cannabis. According to the Last Prisoner Project, inmates remain incarcerated even though House Bill 1438 establishes that persons who have been convicted on an offense are granted a pardon because the Bill provides no resentencing or commutation procedures, and the process to have sentences pardoned is slow.
In examining the injustices of carceral punishment, statistics like these show that these injustices are not an anomaly, but rather the norm. Because prisons are premised on punishment, rather than transformative healing, health, and prevention, prisons are a human rights issue, rather than a criminal justice issue. Prisons are premised on punishment, rather than transformative healing and health, and prevention. As a result, resources and funding which are currently given to our present system of policing and prisons should be reallocated to tools that actually serve the community, rather than on incarceration.
The Ninth Circuit Rules on Net Neutrality, Putting State Regulations of the Internet from Mozilla v. FCC to the Test
Net neutrality (or network neutrality) is the idea that internet service providers (ISPs), such as Verizon or Comcast, should not be able to block or prioritize different sorts of data. The Ninth Circuit, which is comprised of Alaska, Arizona, California, Guam, Hawaii, Idaho, Montana, Nevada, Northern Mariana Islands, Oregon, and Washington state, is the largest Court of Appeals in the United States both in population and land mass. Recently, the Ninth Circuit ruled in a case that net neutrality requirements applied to internet service providers in those states. This decision put to test the U.S. Court of Appeals for the District of Columbia’s 2019 decision of Mozilla v. FCC, which ruled that states would be able to create regulations regarding net neutrality.