Food and Drug Law Commons^™

Pills, Powders, And Proprietary Blends: The Ip And Regulatory Battle Over Dietary Supplement Transparency, Anna Marie Saunders

Georgia Journal of Law & Technology

Available in the form of pills, powders, gummies, bars, and countless other options, dietary supplements have become a cornerstone of the health and wellness industry and a popular product amongst health-conscious consumers. Fueled by the rise of social media influencers and a surge in health-awareness following the COVID-19 pandemic, the supplement industry has experienced rapid growth, evolving into a multi-billion-dollar market.  While widely embraced, these products often face criticism due to labeling and marketing practices that leave  consumers with an incomplete understanding of exactly they are consuming.  This tension arises from the unique legal intersection governing dietary supplements.  These products …

The Transatlantic Clinical Trial Transparency Gap, Gabriela Lenarczyk

Georgia Journal of Law & Technology

Clinical trial data occupy a contested space between private commercial assets and public goods. While the United States Food and Drug Administration (FDA) has historically shielded these data through expansive trade-secret interpretations, the European Union (EU) has adopted a more open disclosure regime. This Article compares the two regimes and traces how the EU’s two-decade journey toward transparency has become a key reference for researchers and advocates of open data-sharing.

Focusing on EU practices—targeted redactions, time-bound access, granular disclosure guidelines—the paper shows that U.S. objections to broader transparency often rest on overstated concerns about competitive harm. A Filspari (sparsentan) case …

The Immigration Implications Of Presidential Pot Pardons, Jason A. Cade

Scholarly Works

This Essay examines the immigration implications of President Joe Biden’s Proclamation on October 6, 2022, pardoning most federal and D.C. offenders who committed the offense of simple marijuana possession. A late twentieth century interpretive shift by the Board of Immigration Appeals holds that pardons only prevent deportation for certain criminal history categories, which do not include controlled substance offenses, and thus far lower federal courts have deferred to the agency’s approach.Nevertheless, according to the analysis I offer, President Biden’s cannabis pardons should be deemed fully effective to eliminate all immigration penalties. All of the immigrant pardon cases to reach the …

Off-Label Innovations, David A. Simon

Georgia Law Review

Modern medicine faces many significant problems. This Article is about two of them. The first is that approved drugs have many potential therapeutic uses that are never identified, investigated, or developed. The second is the routine practice of physicians prescribing approved drugs for unapproved uses—so-called “off-label” uses. These problems seem very different. Failure to invest in potential new uses is an innovation problem: firms lack incentives to research and develop new uses of old drugs. The problem of off-label uses, on the other hand, is one of safety and efficacy: off-label uses are risky because they are not supported by …

Agents Of Bioshield: The Fda, Emergency Use Authorizations, And Public Trust, Kirstiana Perryman

Georgia Law Review

The SARS-CoV-2 pandemic spurred the U.S. Food & Drug Administration (FDA) to utilize the Emergency Use Authorization (EUA) procedure more than ever before. The pandemic pushed the relatively obscure procedure into public consciousness, making it a frequent topic of discussion and debate. The EUA procedure permits the FDA Commissioner to authorize the introduction of drugs, devices, or biological products into interstate commerce for use in an actual or potential emergency. To issue an authorization, the FDA Commissioner must determine that it is “reasonable to believe,” based on the “totality of the evidence,” that the product “may be effective.” This standard …

The Ip Of Ipas, Stephen Wolfson, Brian Roth, Chase Scott, Dustin Watts, Charles Hicks, Shivani Patel

Other Colloquium, Conferences, and Symposia

Hosted by the Journal of Intellectual Property Law, this panel brought Brian Roth (Southern Brewing Co.), Chase Scott (Taylor, Feil, Harper & Lumsden, P.C.), and Dustin Watts (Terrapin Beer Co.) together with Stephen Wolfson (Research & Copyright Services Librarian, UGA Law School) and students from the Journal of Intellectual Property Law to discuss how breweries are navigating intellectual property issues. Free koozies to commemorate the event were distributed.

Regulatory Response To E-Cigarettes, Morgan Johnson

Georgia Journal of International & Comparative Law

No abstract provided.

Comment: Containerization Of Contraband: Battling Drug Smuggling At The Fourth Busiest Container Handling Facility In The United States, Adam Smith

Georgia Journal of International & Comparative Law

No abstract provided.

Conference Of Soviet And American Jurists On The Law Of The Sea And The Protection Of The Marine Environment, Milton Katz, Richard R. Baxter, O. V. Bogdanov, William E. Butler, Thomas M. Franck, Richard Frank, P. P. Gureev, John L. Hargrove, L. A. Ivanaschenko, Y. Kasmin, V. A. Kiselev, B. M. Klimenko, H. G. Knight, O. S. Kolbasov, A. L. Kolodkin, V. M. Koretsky, F. N. Kovalev, V. N. Kudrjavtsev, B. A. Kuvshinnikov, M. I. Lazarev, A. L. Makovsky, Charles W. Maynes, P. A. Moiseev, John N. Moore, A. P. Movchan, T. M. Starzhina, Robert E. Stein, Grigory I. Tunkin, E. T. Usenko, A. F. Vysotsky, A. K. Zhudro

Georgia Journal of International & Comparative Law

Included in the papers for the Conference of Soviet and American Jurists on the Law of the Sea and the Protection of the Marine Environment:

Introduction by Milton Katz and Richard R. Baxter, p. 1

Freedom of Scientific Research in the World Ocean by A.F. Vysotsky, p. 7

The International Law of Scientific Research in the Oceans by Richard R. Baxter, p. 27

Responsibility and Liability for Harm to the Marine Environment by Robert E. Stein, p. 41

Liability for Marine Environment Pollution Damage in Contemporary International Sea Law by A. L. Makovsky, p. 59

Protection of the Marine Environment …

A Trademark Holder's Hangover: Reconciling The Lanham Act With The Alcohol And Tobacco Tax And Trade Bureau's System Of Designating American Viticultural Areas, Julia Lynn Titolo

Georgia Journal of Law & Technology

No abstract provided.

Why Coca-Cola's Fictional Lawsuit Against Coke Zero For Taste Infringement Is A Losing Battle, Jessica Nicole Cox

Georgia Journal of Law & Technology

No abstract provided.

Price Controls Through The Back Door: The Parallel Importation Of Pharmaceuticals, A. Bryan Baer

Georgia Journal of Law & Technology

No abstract provided.

Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey

Georgia Journal of International & Comparative Law

No abstract provided.

International Fisheries Regulation, John P. Rivers

Georgia Journal of International & Comparative Law

No abstract provided.

Recent Developments And Future Prospects Of The Common Market, Michael Waelbroeck

Georgia Journal of International & Comparative Law

No abstract provided.

The Need For Adequate And Effective Protection Of Intellectual Property: Perspective Of The Private Sector - Patents, Peter C. Richardson

Georgia Journal of International & Comparative Law

No abstract provided.

International Trade - Possible Undermining Of U.S. Pesticide And Food Safety Laws By The Draft Text Of The Uruguay Round Of Gatt Negotiations, Beth Sanders

Georgia Journal of International & Comparative Law

No abstract provided.

African Aids Crisis: Implications From The Rise Of Managed Care In South Africa, J. Christopher Driver

Georgia Journal of International & Comparative Law

No abstract provided.

World Trade Organization Adjudication Of The European Union-United States Dispute Over The Moratorium On The Introduction Of New Genetically Modified Foods To The European Common Market: A Hypothetical Opinion Of The Dispute Panel, Charles W. Smitherman Iii

Georgia Journal of International & Comparative Law

No abstract provided.

Raging Hormones: A Discussion Of The World Trade Organization's Decision In The European Union-United States Beef Dispute, George H. Rountree

Georgia Journal of International & Comparative Law

No abstract provided.

International Trade Law And The U.S.-Eu Gmo Debate: Can Africa Weather This Storm?, Michelle K. Mcdonald

Georgia Journal of International & Comparative Law

No abstract provided.

A Tale Of Two Appellations: A Comparative Study Of International Agreements And Prevailing Law Impacting The Availability Of Seasonal Employees For The Wine-Grape Harvest In California's Napa Valley And France's Bordeaux Appellation, Michael K. Edmonson

Georgia Journal of International & Comparative Law

No abstract provided.

"Where You Stand Depends On Where You Sit": Should The United States' Fda Have Followed The Lead Of Great Britain's Mhra In Banning Antidepressant Drug Use In Children And Adolescents?, Jennifer Dorminey

Georgia Journal of International & Comparative Law

No abstract provided.

B.Y.O. Heroin: Will Canada Finally Recognize The Fundamental Rights Of Injection Drug Users By Providing Access To Safe Injection Facilities?, Robert Marston

Georgia Journal of International & Comparative Law

No abstract provided.

Beer, Liquor, Or A Little Bit Of Both? Getting To The Bottom Of Properly Classifying Flavored Malt Beverages In The United States And Australia, Bryan A. Schivera

Georgia Journal of International & Comparative Law

No abstract provided.

Ignorance, Harm, And The Regulation Of Performance-Enhancing Substances, Lisa Milot

Scholarly Works

There is a disconnect between how legal and sporting authorities, on the one hand, and many elite athletes, on the other, view the use of performance-enhancing substances. While official and popular narratives portray the use of these substances as isolated examples of deviant behavior, to the elite athletes who daily push their bodies beyond societally normal limits of pain and risk, enhancement is oftentimes an accepted part of the job. As a result, efforts to regulate and detect athletes’ use of these substances have consistently captured only a small fraction of the use that exists.

This Article describes the ways …

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway

Scholarly Works

This article will discuss the current state of off-label medicine, relevant legislation in the area, and a proposal designed to capture the benefits of off-label medicine while limiting its dangers when practiced perniciously. Part II will discuss the regulations in place governing off-label promotion and will detail the practice of ghostwriting and its associated concerns. Part III will analyze the costs and benefits of off-label marketing and practice of medicine, and will utilize a case study to demonstrate the predicament of drug manufacturers. Part IV will set forth a proposal to use the newly created Patient-Centered Outcomes Research Institute to …

Litigating Together: Social, Moral, And Legal Obligations, Elizabeth Chamblee Burch

Scholarly Works

In a post-Class Action Fairness Act world, the modern mass-tort class action is disappearing. Indeed, multi-district litigation and private aggregation through contracts with plaintiffs’ law firms are the new mass-tort frontier. But something’s amiss with this “nonclass aggregation.” These new procedures involve a fundamentally different dynamic than class actions: plaintiffs have names, faces, and something deeply personal at stake. Their claims are independently economically viable, which gives them autonomy expectations about being able to control the course of their litigation. Yet, they participate in a familiar, collective effort to establish the defendant’s liability. They litigate from both a personal and …

Taking From Trailblazers: Learning From Those Who Have Gone Before When Approving Biosimilars, John A. Little, Jr.

Georgia Law Review

The creation of an approval pathway for biosimilar biologicalproducts holds tremendous promise for increased competition in the biopharmaceutical market and financial savings to the health care system. Yet, safely achieving these promised benefits depends heavily on the Food and Drug Administration's ability to evaluate and compare these complicated molecules to previously approved products. Because biosimilars are different than generic drugs, the FDA's current practice of considering only its prior finding of safety and efficacy of a reference product is ill-suited for approval of biosimilars. Unfortunately, the new pathway included in recently enacted health care reform legislation ignores this distinction and …

The Public’S Right To Health: When Patient Rights Threaten The Commons, Elizabeth Weeks Leonard

Scholarly Works

This Article offers a contemporary examination of traditional public health objectives to address social problems not amenable to individual resolution. Taking the tradition a step further, it defines a "public health right" that may justify certain government actions that otherwise appear to impair individual rights. For example, lawmakers are considering whether current regulations on prescription drugs should be loosened to allow terminally ill patients to access drugs before they have been tested and approved for the general public. This Article concludes that expanding access to experimental drugs would violate the public health right to scientific knowledge and new drug development. …