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Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales May 2023

Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales

University of Miami Law Review

Cosmetics only first became regulated after a series of tragic events where users were seriously harmed from the use of cosmetic products. These tragic events prompted legislators to enact the Food, Drug, and Cosmetics Act of 1938. Before then, law makers feared that regulating the cosmetic industry would lower the tone of legislation because they considered the cosmetic industry to be inconsequential. At present, the regulatory system in place to protect vulnerable cosmetic consumers is nearly identical to when it was enacted over eighty-six years ago—even though the cosmetic market looks nothing like it did back then. The consumer base …


Moving Away From Masking Pain: A Need For Modernization In Pain Management, Tori Collins Jan 2023

Moving Away From Masking Pain: A Need For Modernization In Pain Management, Tori Collins

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.


Solutions Still Searching For A Problem: A Call For Relevant Data To Support "Evergreening" Allegations, Erika Lietzan, Kristina M. L. Acri Jan 2023

Solutions Still Searching For A Problem: A Call For Relevant Data To Support "Evergreening" Allegations, Erika Lietzan, Kristina M. L. Acri

Faculty Publications

For years pharmaceutical policymaking discussions have been revolving around allegations of supposed “evergreening” by pharmaceutical companies, and policymakers have considered a range of significant policy reforms — including to antitrust law and drug regulatory law — to address this purported problem. This paper evaluates empirical data offered to substantiate “evergreening” and explains that these data — though mostly accurate — do not support proposed policy changes.

The “evergreening” claim is that by securing additional patents and FDA-related exclusivities after approval of their new drugs, brand drug companies enjoy a period of exclusivity in the market that is longer than the …