Author:Andrew Thompson
Improving the Biosimilar and Generic Drug Approval Process
Andrew Thompson Senior Editor Loyola University Chicago School of Law, JD 2023 As discussed previously here and here, patent evergreening and patent thickets are key drivers of prescription drug prices that also operate as a barrier to entry which blocks generic manufacturers from placing lower-cost alternatives on the market. This post will examine how newly …
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FDA-USPTO Collaboration Offers Insight on the Future of Generics
Following the Biden Administration’s release of the Comprehensive Plan for Addressing High Drug prices in September 2021, the Food and Drug Administration (FDA) responded by opening communication with the United States Patent and Trademark Office (USPTO). On September 10, 2021, the FDA sent a letter to the Under Secretary of Commerce for Intellectual Property and Director of the USPTO seeking to further develop the FDA-USPTO relationship. The letters point out that while “bringing more drug competition to the market and addressing the high cost of medicines by improving access to affordable medications is a top priority” for HHS and FDA, the FDA is constrained by its inability to regulate the price of drugs it approves. While the FDA’s 505(b)(2) hybrid NDA and 505(j) ANDA pathway decrease the cost and time to market entry for generics, the FDA’s authority is concentrated in the pre-market review stage, with post-market authority focused on actions such as product seizure of adulterated or misbranded articles, phase-4 confirmatory trials, and other actions intended to assess the safety and efficacy of drugs.
Expanding Generic Approval Benefits Pharmaceutical Manufacturers & Patients
Prescription drug consumers are often left frustrated when confronted with limited generic versions, if any are available, and must resort to paying out-of-pocket for their prescriptions. This is due in part to how the FDA evaluates and approves new drug products prior to market entry. Applications for FDA approval of a drug product reach the FDA by pathways established under the federal Food Drug & Cosmetics Act (FDCA).
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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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.
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.