Administrative Law Commons^™

Drug Approval In A Learning Health System, W. Nicholson Price

Articles

The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …

Environmental Health Regulation In The Trump Era: How President Trump’S Two-For-One Regulatory Plan Impacts Environmental Regulation, Elizabeth Ann Glass Geltman

University of Michigan Journal of Law Reform

This Article explores the Trump regulatory reform agenda and its potential impact on environmental determinants of health. The Article begins with a discussion of the Department of Commerce’s (DOC or Commerce) initial fact-finding investigation to evaluate the impact of federal regulations on domestic manufacturing. The Article next presents an overview of the Trump administration’s regulatory reform formula as announced in E.O. 13771 and the interim guidance explaining E.O. 13771 and E.O. 13777 (the executive order announcing the Trump administration’s plans to enforce the regulatory reform plan announced in E.O. 13771). The Article then examines the federal agency initiatives undertaken in …

Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar

Articles

In an ambitious effort to slow the growth of health care costs, the Affordable Care Act created the Center for Medicare and Medicaid Innovation (CMMI) and armed it with broad authority to test new approaches to reimbursement for health care (payment models) and delivery-system reforms. CMMI was meant to be the government’s innovation laboratory for health care: an entity with the independence to break with past practices and the power to experiment with bold new approaches. Over the past year, however, the Department of Health and Human Services (HHS) has quietly hobbled CMMI, imperiling its ability to generate meaningful data …

Improving Generic Drug Approval At The Fda, Kathleen Craddock

Michigan Journal of Environmental & Administrative Law

Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about …

Reforming Regenerative Medicine Regulation, Sarah Duranske

Georgia State University Law Review

Regenerative medicine is defined as the branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells or tissues. It includes a variety of approaches, such as transplanting cells to promote healing, editing genes in cells to attack cancer, and even building organs from biological materials. Regulating regenerative medicine therapies is no easy task. Finding a balance between competing interests–enabling timely access for needy patients while simultaneously ensuring a positive benefit/risk profile and promoting the development of beneficial innovations–is hard enough at any given point in time. But add in constantly advancing scientific knowledge and increasing …

Fighting For Your Life In America: A Study Of "Right To Try" Laws Throughout The Country, Danielle Delgrosso

St. John's Law Review

(Excerpt)

This Note argues that there should be a federal statute granting terminally ill patients access to experimental drugs, but that the Trickett Wendler Act, as written is not the proper vehicle for change. An ideal congressional “Right to Try” statute should be crafted to make experimental drugs realistically obtainable for terminally ill patients while protecting those patients and their quality of life. The Trickett Wendler Act’s weaknesses prevent it from reaching this objective because it is too deferential to already unclear state Right to Try laws. Part I explores the right to try movement generally, explaining what a “right …

The Burden Of A Good Idea: Examining The Impact Of Unfunded Federal Regulatory Mandates On Medicare Participating Hospitals, Rachel J. Suddarth

Washington and Lee Journal of Civil Rights and Social Justice

No abstract provided.

How Subterranean Regulation Hinders Innovation In Assisted Reproductive Technology, Myrisha S. Lewis

Cardozo Law Review

Most scholars believe assisted reproductive technology is subject only to minimal regulation, especially by the federal government. This belief I contend, is wrong. In this Article, I examine agency documents, statements by officials, and letters that the U.S. Food and Drug Administration (FDA) has sent to physicians and researchers over the past fifteen years to reveal an overlooked regulatory program. The FDA has been targeting new forms of assisted reproductive technology that involve small genetic modifications (advanced assisted reproductive technologies or AARTs) through regulatory actions that receive little public, media, or scholarly attention. I term this method of regulation "subterranean …

Hb 249 - Controlled Substances And Prescription Drug Monitoring Database, Emily R. Polk, Brandon M. Reed

Georgia State University Law Review

The Act amends Georgia’s controlled-substances statutes to expand medical provider requirements to record prescription drug information in an electronic prescription drug monitoring program database (PDMP). Medical providers are now required to use the PDMP to enter information about their prescription of certain types and quantities of opioids. The purpose of the act is to fight Schedule II opioid abuse throughout the state of Georgia. A medical provider’s failure to report required information is reported to his or her respective state regulatory board for possible reprimand. In addition to mandatory reporting, the Act includes various other provisions related to regulating opioid …

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

Faculty Publications By Year

There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …

Changing Hearts, Minds, And Structures: Advancing Equity And Health Equity In State Government Policies, Operations, And Practices In Minnesota And Other States, Susan R. Weisman, Ayah Helmy, Vayong Moua, Julie Ralston Aoki

Mitchell Hamline Law Review

No abstract provided.

Shared Goals: How The Hhs Office Of Inspector General Supports Health Care Industry Compliance Efforts, Gregory E. Demske, Geeta Taylor, James Ortmann

Mitchell Hamline Law Review

No abstract provided.

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

The Faa’S Mental Health Standards: Are They Reasonable?, Katie Manworren

Journal of Air Law and Commerce

No abstract provided.

Regulating Black-Box Medicine, W. Nicholson Price Ii

Michigan Law Review

Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …

The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah

Michigan Telecommunications & Technology Law Review

Until the December 2016 passage of the Cures Act, the FDA had regulatory power over clinical decision support (CDS) software; however, the Act removed a large group of CDS software from the FDA’s statutory authority. Congressional intent was to increase innovation by removing regulatory blockades—such as device testing and certification—from the FDA’s purview. This note argues that the enactment of this specific provision of the Act will instead stymie innovation and overlook the unfortunate safety consequences inherent in its deregulation. CDS software is a burgeoning field ripe for innovation; however, rapid innovation can often lead to a slew of mistakes—mistakes …

Anthem Health Plans Of Maine, Inc. V. Superintendent Of Insurance: Judicial Restraint Or Judicial Abdication?, David E. Sorensen

Maine Law Review

When Maine’s Superintendent of Insurance told the state’s largest health insurer that it could not profit in 2009, her decision ended up on appeal before the Maine Supreme Judicial Court, sitting as the Law Court, in Anthem Health Plans of Maine, Inc. v. Superintendent of Insurance. As part of its annual rate approval process, Anthem had requested a 3% profit and risk margin on its individual lines of health insurance in Maine. Superintendent Mila Kofman denied this request under her statutory authority to deny any rate increase proposals that are “excessive, inadequate or unfairly discriminatory.” The Superintendent held that a …

Pharmaceutical Federalism, Patricia J. Zettler

Faculty Publications By Year

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …

Workin’ 9:00–5:00 For Nine Months: Assessing Pregnancy Discrimination Laws In Georgia, Kaitlyn Pettet

Georgia State University Law Review

As demonstrated in this Note, there is still a considerable way to go before women are no longer forced to choose between pregnancy and keeping their career. Allegations of pregnancy discrimination in the workplace are also on the rise.

In 1997, 4,000 plaintiffs filed complaints with the Equal Employment Opportunity Commission (EEOC). By 2011, that number rose to 5,800. The EEOC won significant damages in pregnancy discrimination cases, demonstrating a greater tendency towards discrimination in the workplace. Additionally, this rise in claims and awards caught the attention of the nation’s media, placing new emphasis on the treatment of pregnant women …

Food Date Labels And Hunger In America, Gwen B. Thomson

Concordia Law Review

Millions of Americans go hungry, while 40% of the food in the United States is wasted. Research has shown that 43% of the waste occurs in homes and that consumers are making decisions about purchasing and throwing away food without understanding the meaning of the food date labels. One of the most cost-effective ways to begin to effect a change is to eliminate the myriad of confusing food date labels so that individuals do not throw away good food. In May 2016, the Food Date Labeling Act of 2016 was proposed in both houses of Congress. This bicameral bill was …

Mitochondrial Replacement Therapy And The Regulation Of Reproductive Genetic Technologies In The United States, Bob Zhao

Duke Law & Technology Review

The ability to alter the genes of future generations no longer belongs in the realm of science fiction. The genetic modification capabilities of modern science are advancing rapidly. Mitochondrial replacement therapy (MRT) represents the first crossing of the germline barrier in humans, and as of February 2015, it is the first procedure of its kind to be legalized in the Western world. How Congress decides to regulate MRT will influence future regulation of all genetic manipulation technologies. This brief argues that the current patchwork regulatory framework established in the United States is insufficient to deal with the complex issues MRT …

Should Regulatory Compliance Be A Goal Or A Constraint For Health Care Companies? Finding Effective Methods To Assure Compliance With The Federal Anti-Kickback Statute And The False Claims Act, Roni A. Elias

Florida A & M University Law Review

The stereotypical conception of compliance is reinforced by some of the fundamental assumptions about what the primary objectives of a corporation should be and about how a corporation should accomplish those objectives. According to the prevailing theory of corporate structure, a corporation exists for the sole purpose of earning profits for its shareholders, and all of its actions are to be directed toward that end. If compliance with the law is not an inherently profit making activity, it is to be treated as a constraint on the corporation's efficient operation. According to this view, compliance will generally be considered a …

Dental Board Of California, Jena Scarborough, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

Department Of Managed Health Care, Jennifer Pardue, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.

Board Of Pharmacy, Mariam J. Saleh, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

Medical Board Of California, Kayla Watson, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.

Board Of Registered Nursing, Ashkan Hayatdavoudi, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler

Faculty Publications By Year

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …

On Health, Law, And Religion, Stacey A. Tovino

Scholarly Works

The Supreme Court recently decided a number of cases involving health, law, and religion, including Whole Woman's Health v. Hellerstedt, Zubik v. Burwell, and Burwell v. Hobby Lobby Stores, Inc. These cases were important for understanding constitutional undue burden limitations and the boundaries of religious exercise during the Obama Administration. Unfortunately, the Supreme Court's recent opinions addressing health, law, and religion have little value for many health law professors and most practicing health care attorneys. These individuals, tasked with teaching and applying the thousands of federal and state statutes, regulations, and government guidance documents that address a wide …

The Triage And Treatment Of Healthcare Institutions In Distress: How To Involve State Regulators In Healthcare Bankruptcies And Receiverships, Brian P. Stern, Christopher J. Fragomeni

Roger Williams University Law Review

No abstract provided.