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Full-Text Articles in Law
The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan
The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan
Srividhya Ragavan
This Article is set in the background of the consequences of the WTO’s prescriptions on patenting of life-saving medications which has largely contributed to the morphing of patents o n life-saving medication into a luxury. Remarkably, there has been a transformation of the role of patents in the context of pharmaceutical innovation into a strategic business tool leading to a larger interest in creation and sustenance of regulatory rights. The biggest global development in this area is an increased effort to strengthen exclusivity using regulatory protections for all chemicals, and even, biologics, involved in all stages of drug development. Consequently, …
A Failure To Consider: Why Lawmakers Create Risk By Ignoring Trade Obligations, David R. Kocan Professor
A Failure To Consider: Why Lawmakers Create Risk By Ignoring Trade Obligations, David R. Kocan Professor
David R. Kocan Professor
The U.S. Congress frequently passes laws facially unrelated to trade that significantly impact U.S. trade relations. These impacts are often harmful, significant, and long-lasting. Despite this fact, these bills rarely receive adequate consideration of how they will impact trade. Without this consideration, Congress cannot properly conduct a cost-benefit analysis necessary to pass effective laws. To remedy this problem, the U.S. Trade Representative should evaluate U.S. domestic law to determine whether it is consistent with international trade obligations. Moreover, the U.S. Congress committee structure should be amended so that laws that might impact trade are considered within that light. In the …
Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer
Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer
Parker Tresemer
Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is …
The Preemption Pentad: Federal Preemption Of Products Liability Claims After Medtronic [V. Lohr], Robert B. Leflar, Robert S. Adler
The Preemption Pentad: Federal Preemption Of Products Liability Claims After Medtronic [V. Lohr], Robert B. Leflar, Robert S. Adler
Robert B Leflar
Taking the language of the federal consumer protection statutes out of historical context and inattentive to those laws' original purposes, judges dissatisfied with the expansion of state products liability law have in recent years read preemption provisions of these federal statutes to bar a wide range of claims that would otherwise be viable under state law. In Medtronic v. Lohr, the Supreme Court (per Justice Stevens) severely constrained the scope of the federal preemption defense in the context of the federal medical device law. But the implications of the Medtronic decision for cases involving products in other regulatory categories remain …
Public Accountability And Medical Device Regulation, Robert B. Leflar
Public Accountability And Medical Device Regulation, Robert B. Leflar
Robert B Leflar
In enacting the Medical Device Amendments of 1976, Congress instituted a flexible system of regulatory controls over a vast array of health care products. Analyzing the complex statute and its legislative history, Professor Leflar finds at the law's core a structure designed to ensure the Food and Drug Administration's accountability to the public for its regulatory actions. Reviewing the history of FDA's implementation of the medical device law, however, the author demonstrates that FDA has strayed widely and, he contends, illegally from the congressionally mandated structure of public accountability. In particular, in its review of new-model medical devices in the …