Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues. Below are the citations for papers identified from the month of February. The selections feature topics ranging from an analysis of the approval and marketing of biosimilars with a skinny label and their associated Medicare savings, to a discussion of the Philips Respironics recall and the need for reforms to U.S. medical device regulation, to a review of price negotiation processes in peer countries and potential lessons for Medicare price regulation. A full posting of abstracts/summaries of these articles may be found on our website.
Tag: Biosimilars
Monthly Round-Up of What to Read on Pharma Law and Policy
By Ameet Sarpatwari, Alexander Egilman, and Aaron S. Kesselheim
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.
Below are the citations for papers identified from the month of November. The selections feature topics ranging from an analysis of the approval and marketing of biosimilars with skinny labels and their associated savings to Medicare, a discussion of the Philips Respironics recall and the need for reforms to medical device regulation, to a review of price negotiation processes in peer countries and potential lessons for Medicare price regulation. A full posting of abstracts/summaries of these articles may be found on our website.
Monthly Round-Up of What to Read on Pharma Law and Policy
By Ameet Sarpatwari, Alexander Egilman, Beatrice Brown, and Aaron S. Kesselheim
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.
Below are the citations for papers identified from the month of January. The selections feature topics ranging from a discussion of why state laws restricting mifepristone access may be subject to federal preemption, to an analysis of patents impacting the availability of biosimilars, to an evaluation of the hypothetical out-of-pocket costs of guideline-recommended medications for the treatment of older adults with multiple chronic diseases. A full posting of abstracts/summaries of these articles may be found on our website.
The Risk of Pervasive Trade Secret Practices Within the Life Sciences
By Matt Bauer
The changing landscape of the life sciences industry relies more and more on a form of intellectual property protection called trade secrets to safeguard mechanisms of manufacturing and process knowledge not always included within life science patents.
To the public, this means the methods of production for life saving therapeutics may be kept indefinitely in the hands a single company, never to enter the public domain.
Monthly Round-Up of What to Read on Pharma Law and Policy
By Ameet Sarpatwari, Beatrice Brown, Alexander Egilman, Aviva Wang, and Aaron S. Kesselheim
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.
Below are the citations for papers identified from the month of August. The selections feature topics ranging from an overview on the evolution of medical device regulation in the United States, to an analysis of the impact of the disclosure of expanded access policies mandated by the 21st Century Cures Act, to an evaluation of how litigation has impacted the success of the Biologics Price Competition and Innovation Act.
A full posting of abstracts/summaries of these articles may be found on our website.
The Ongoing Step Therapy Debate
By Laura Karas
Senator Lisa Murkowski’s (R-AK) reintroduction this February of a federal bill, the Safe Step Act, has revived the debate over the prudence of step therapy protocols.
Step therapy is an insurer utilization-management tool imposed in response to high drug prices. As its name implies, step therapy requires “steps” before a patient can receive his preferred medication (i.e., the one his provider has prescribed). Typically, a patient must “try and fail” a less costly medication or series of medications before becoming eligible for insurance coverage of the medication in question. In effect, step therapy allows an insurer’s “preferred therapy” to supersede patient and provider preference.
The need for step therapy is closely bound to the problem of high drug prices. But the crux of the step therapy debate boils down to the following: Who should decide which pharmaceutical drugs your health plan covers? You and your doctor, or your insurer?
Pharmaceutical Patents on Manufacturing Methods: Groundless or Well-Supported?
By Laura Karas
Are manufacturing method patents — patents not on a pharmaceutical drug itself, but on a method of production of a drug — warranted intellectual property protections, or groundless obstacles to competition?
Patents protect and reward innovation by permitting the patent-holder the exclusive right to make, use, and sell the invention for a twenty-year period. Pharmaceutical companies have attracted scrutiny, criticism, and legal challenges for amassing large numbers of patents on pharmaceutical drugs, especially high-priced and high revenue-earning drugs.
Here I explore the topic of pharmaceutical patents on methods of production and translate into layman’s terms some thought-provoking recent scholarship by innovation scholars W. Nicholson Price and Arti Rai.
When “Pay-for-Delay” Becomes “Delay-Without-Pay”: Humira Antitrust Claims
By Laura Karas
In June 2020, the U.S. District Court for the Northern District of Illinois dismissed state and federal antitrust claims against AbbVie, maker of Humira (adalimumab), for accruing more than 130 patents on the top-selling drug and asserting allegedly unmeritorious patent infringement claims against makers of adalimumab biosimilars. AbbVie then settled the patent infringement litigation by entering into agreements with eight drug makers to allow adalimumab biosimilars to enter the U.S. market in 2023 and the European market in 2018.
In my last post, I discussed the district court’s memorandum opinion finding that “the vast majority” of AbbVie’s conduct was not “objectively baseless petitioning” and was therefore immunized under the Noerr-Pennington doctrine. In this post, I explore several problematic aspects of the court’s reasoning for rejecting the claims of pay-for-delay and market allocation.
Year in Review: Biosimilars
By Laura Karas
Now that 2020 has come to a close, it’s worth taking stock of the progress the United States has made during the last year with respect to biosimilars, pharmaceutical therapies that are highly similar to a reference biologic product and possess no clinically meaningful differences.
Monthly Round-Up of What to Read on Pharma Law and Policy
By Ameet Sarpatwari, Beatrice Brown, Neeraj Patel, and Aaron S. Kesselheim
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.
Below are the citations for papers identified from the month of October. The selections feature topics ranging from a commentary calling for reconsideration of the FDA’s risk evaluation and mitigation strategy (REMS) program for mifepristone, to an analysis of clinical development times for biosimilars seeking FDA approval, to an editorial describing the challenges of using the Defense Production Act to address drug shortages. A full posting of abstracts/summaries of these articles may be found on our website.