Category:

Drugs & Devices

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.

Compliance and Aducanumab – How Should Providers Balance FDA and CMS Guidance?

As my colleague at Inside Compliance discussed here in September, the FDA approved Aducanumab for the treatment of Alzheimer’s Disease on June 7, 2021. Aducanumab, marketed as Aduhelm, is intended to reduce beta-amyloid levels. This compound is responsible for forming a “plaque” which inhibits neuron function and eventually triggers neuronal apoptosis (death of neurons). Now, a recent decision by CMS on insurance reimbursement for aducanumab has increased the compliance responsibilities of providers.

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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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.

The New Hope and Frustration for Alzheimer’s Patients

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.

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

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.

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.