Law Commons^™

The Burden On Society From Eleventh-Hour "Citizen Petitions" Filed To Slow Generic Drugs, Feldman Robin

Maryland Law Review Online

No abstract provided.

Requiem For A Remedy: The Law And Economics Of Mutual Pharmaceutical V. Bartlett’S Over-Preemption, Robert C. Baker Iii

Maryland Law Review Online

No abstract provided.

New York: Public Health Implications Of The 'Soda Ban' Ruling, Andrew Geltman

Homeland Security Publications

No abstract provided.

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Maryland Law Review Online

No abstract provided.

What Is The Best Way For Manufacturers And Physicians To Apply Sunscreen To Avoid Being Burned By The Final Sunshine Act Regulations?, Abraham Gitterman

Student Articles and Papers

This [article] explains the requirements under the Patient Protection and Affordable Health Care Act’s Physician Payment Sunshine Act that all medical product manufacturers report to Health and Human Services (HHS) any payment or transfer of value made to physicians and teaching hospitals. Author Abraham Gitterman ... warns that manufacturers may face adverse consequences of public access to payment data, including fraud and abuse investigations and private litigation actions. He recommends that manufacturers begin training employees to ensure compliance with the statute and reduce the likelihood of further investigations. He further suggests that the Center for Medicare & Medicaid Services (CMS) …

Christopher V. Smithkline Beecham Corporation: An Unsurprising Loss For Pharmaceutical Sales Representatives And An Erosion Of Power For Administrative Agencies, Anna Johnston

Proxy

No abstract provided.

Insights In Enforcement, Litigation & Compliance For Pharmaceutical And Medical Device Manufacturers At Fdli's Enforcement, Litigation And Compliance Conference, December 12-13, 2012, Thomas Sullivan, Abraham Gitterman

Student Articles and Papers

No abstract provided.

Executives Should Think Twice Before Accepting Pleas 'Related To Fraud': The Expansion Of Exclusion Under The Park Doctrine, Abraham Gitterman

Student Articles and Papers

No abstract provided.

Drug Policy In Context: Rhetoric And Practice In The United States And The United Kingdom, Richard C. Boldt

Faculty Scholarship

The history of narcotics use and drug control in the U.S. before passage of the Harrison Act in 1914 is similar in important respects to that in the U.K. during the same period. Although the two countries’ paths diverged significantly over the ensuing decades, there has been a convergence of sorts in recent years. In the United States, the trend lines have moved from an active “war on drugs” in which criminal enforcement and punishment have been the primary rhetorical and practical instruments of policy to an evolving approach, at least at the federal level, characterized by a somewhat more …

Regulating Tobacco Advertising And Promotion: A "Commerce Clause" Overview For State And Local Governments, Kathleen Dachille

Faculty Scholarship

On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act, giving the U.S. Food and Drug Administration (FDA) comprehensive authority to regulate the manufacturing, marketing, and sale of tobacco products. The new law represents the most sweeping action taken to date to reduce what remains the leading preventable cause of death in the United States.

To help you understand the potential ways in which state and local regulation of tobacco product marketing and promotion might be limited by the U.S. Constitution’s Commerce Clause, the Tobacco Control Legal Consortium, a collaborative network of …

Regulatory Dysfunction: How Insufficient Resources, Outdated Laws, And Political Interference Cripple The 'Protector Agencies', Sidney A. Shapiro, Rena I. Steinzor, Matthew Shudtz

Faculty Scholarship

In the last several years, dramatic failures of the nation’s food safety system have sickened or killed tens of thousands of Americans, and caused billions of dollars of damages for producers and distributors of everything from fresh vegetables to granola bars and hamburger meat. In each case, the outbreak of food-borne illness triggered what can only be described as a frantic scramble by health officials to discover its source. Inevitably, the wrong lead is followed or a recall is too late or too narrow to prevent further illnesses, and the government has to defend itself against withering criticism. Americans expect …

Protecting Protected Speech: First Amendment Taxonomy And The Food And Drug Administration's Regulation Of "Enduring Materials", Daniel J. Gilman

Faculty Scholarship

Numerous comments have called upon the Food and Drug Administration (FDA) to exercise restraint in its treatment of the dissemination of “enduring materials” (e.g., textbooks, journal articles, etc.) that address off-label uses of drug or biological products. This article considers the constitutional protections that apply to enduring materials as examples of commercial speech, and questions whether such materials—even though distributed by manufacturers—might be viewed more properly as scientific speech. Four conclusions will be set forth: 1) enduring materials regarding off-label uses deserve at least as much protection as the Constitution affords commercial speech; 2) there are good reasons to think …

Rehabilitative Punishment And The Drug Treatment Court Movement, Richard C. Boldt

Faculty Scholarship

No abstract provided.