Digital Commons Network^™

Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka

Vanderbilt Law Review

When health is at stake, bureaucratic delays can be disastrous. This is especially true in the field of pharmaceutical regulation. Fortunately, concerned parties—ranging from research institutions and universities to doctors and pharmaceutical companies—can file citizen petitions to urge the Food and Drug Administration (“FDA”) to regulate potentially risky drugs through Risk Evaluation and Mitigation Strategies (“REMS”) programs. But despite submitting comprehensive citizen petitions calling for changes to REMS determinations, petitioners regularly await the FDA’s response for years. When these petitioners, still awaiting an FDA determination, have sought recourse in the courts, the agency has argued that these petitioners have not …

Executive Capture Of Agency Decisionmaking, Allison M. Whelan

Vanderbilt Law Review

The scientific credibility of the administrative state is under siege in the United States, risking distressful public health harms and even deaths. This Article addresses one component of this attack-—executive interference in agency scientific decisionmaking. It offers a new conceptual framework, “internalagency capture,” and policy prescription for addressing excessive overreach and interference by the executive branch in the scientific decisionmaking of federal agencies. The Article’s critiques and analysis toggle a timeline that reflects recent history and that urges forward-thinking approaches to respond to executive overreach in agency scientific decisionmaking. Taking the Trump Administration and other presidencies as test cases, it …

Reputation And Authority: The Fda And The Fight Over U.S. Prescription Drug Importation, Thomas J. Bollyky, Aaron S. Kesselheim

Vanderbilt Law Review

There is popular and bipartisan support for legalizing the importation of lower-cost medicines from Canada to help reduce the high prescription drug costs that Americans pay. Despite the wide interest in this policy, attempts over the last sixteen years to create a formal system for large-scale prescription drug importation in the United States have failed. The Trump Administration recently issued a final rule to enable the legal importation of prescription drugs from Canada, but the rule has important design flaws and seems destined to suffer a similar fate as previous efforts.

In this Article, we argue that prescription drug importation …

The Authorization Continuum: Investigating The Meaning Of "Authorization" Through The Lens Of The Controlled Substances Act, Breanna C. Philips

Vanderbilt Law Review

Federal prohibitions are ubiquitous in society. These prohibitions may be absolute, providing no exceptions, or they may be qualified, providing exemptions that allow specified parties to avoid a law's reach. The power to exempt parties from a prohibition is not limited to the federal government; it may be delegated to states or smaller polities as well. This is the structure that Congress employed when enacting the Mail Order Drug Paraphernalia Control Act: the Act bans, among other things, the sale and distribution of drug paraphernalia but provides an exemption for "any person authorized by local, State, or Federal law."

While …

Seeing Through The Murky Vial: Does The Fda Have The Authority To Stop Compounding Pharmacies From Pirate Manufacturing?, Michael Snow

Vanderbilt Law Review

In late 2012 and early 2013, tainted steroid shots from the New England Compounding Center ("NECC") caused fifty-five deaths and 745 cases of fungal meningitis in twenty states.' On October 1, 2012, the Food and Drug Administration ("FDA") inspected NECC and found vials of steroids filled with enough floating contamination to be visible to the human eye. These NECC steroid shots were distributed primarily to treat back pain, but the patients who received them were injected with foreign matter containing the deadly fungi Exserohilum rostratum or Aspergillus fumigatus. The earliest reported death from fungal meningitis caused by NECC was seventy-eight-year-old …

Giving The Terminally Ill Their Due (Process): A Case For Expanded Access To Experimental Drugs Through The Political Process, Linda K. Leibfarth

Vanderbilt Law Review

The stated purpose of the Food and Drug Administration ("FDA" or "Agency") is "to promote and protect the public health." In furtherance of this end, the FDA has created a regulatory framework to ensure that drugs marketed to the general public are both safe and effective. However, critics insist that the FDA's paternalistic drug approval process does little to achieve its goal. At the onset of the AIDS epidemic in the 1980s, criticism of the FDA intensified, as the FDA's lengthy and expensive drug approval process hindered terminally ill AIDS patients' access to potentially lifesaving treatment. Advocates for these patients …

Federalism And Drug Control, Michael M. O'Hear

Vanderbilt Law Review

Federalism issues have been neglected in the scholarship on drug control policy. This Article addresses both empirical and normative questions relating to federal-state-local relations in the "war on drugs." Contrary to common views of federal domination and national uniformity, drug control policy actually varies considerably from state to state. State diversity has increased since the mid- 1990s, when drug reformers began to use the ballot initiative to change state laws. While the federal government has contested these reforms, it has not sought to use its preemption powers to enforce federal preferences.

The Article employs public choice models to explain the …

Just What The Doctor Ordered: The Admissibility Of Differential Diagnosis In Pharmaceutical Product Litigation, Wendy Michelle Ertmer

Vanderbilt Law Review

In the decade since Daubert v. Merrell Dow Pharmaceuticals Inc., federal judges have exercised their role as gatekeepers of expert witness testimony to evaluate many different categories of scientific evidence. They have not done so without controversy, however. Because the element of causation in pharmaceutical product litigation is frequently dispositive, the application of Daubert to scientific evidence of causation has been particularly contentious. Plaintiffs in such cases must prove both general causation-that the product is capable of causing an injury of the type from which the plaintiff suffers-and specific causation-that the product was the actual cause of the plaintiffs injury. …

Drug Treatment Courts And Emergent Experimentalist Government, Michael C. Dorf, Charles F. Sabel

Vanderbilt Law Review

Despite the continuing "war on drugs," the last decade has witnessed the creation and nationwide spread of a remarkable set of institutions, drug treatment courts. In drug treatment court, a criminal defendant pleads guilty or otherwise accepts responsibility for a charged offense and accepts placement in a court-mandated program of drug treatment. The judge and court personnel closely monitor the defendant's performance in the program and the program's capacity to serve the mandated client. The federal government and national associations in turn monitor the local drug treatment courts and disseminate successful practices. The ensemble of institutions, monitoring, and pooling exemplifies …

Liquor And Lemon: The Establishment Clause And State Regulation Of Alcohol Sales, Steven L. Lane

Vanderbilt Law Review

Approximately half of the fifty states and numerous municipalities maintain and enforce legislation that prohibits the sale of alcohol close to churches. A number of other states allow their liquor- licensing authorities to consider proposed vendors' proximity to churches. Likewise, states and municipalities in all regions of the country have laws that restrict the sale of alcohol on Sunday. Notwithstanding the secular justifications offered by the proponents of such legislation, analysis reveals that it is religiously motivated. Although the Bible contains no clear mandate against the sale, purchase, or consumption of alcohol, history illustrates that prohibitions on the sale of …

Drug Diplomacy And The Supply-Side Strategy: A Survey Of United States Practice, Sandi R. Murphy

Vanderbilt Law Review

The illicit drug trade is gigantic. The United Nations reports that the annual value of the illegal drug trade worldwide is 250 to 300 billion dollars.' The United States leads the world in illicit drug consumption and suffers a myriad of drug-related problems. The majority of marijuana, cocaine, and heroin consumed in the United States through out the 1980s was supplied by six Latin American and Caribbean countries. These countries, like the United States, are plagued by drug-related problems. The governments and citizens of both drug producing and drug transit countries are increasingly victims of crime, violence,and corruption.

Attendant to …

Government Drug Testing: A Question Of Reasonableness, James M. Sokolowski

Vanderbilt Law Review

The 1980s were noted for the escalation of the war on drugs. The dominant public perception was that drug use is a hideous evil that must be stopped, even at a great cost of public resources and personal liberties. Parents, politicians, and law enforcement officials rallied to battle drug use.2 Tremendous expenses and limited victories did not slow the war on drugs.'It cannot be disputed that drug abuse is widespread. More than seventy million Americans have experimented with illegal drugs, and twenty-three million currently use an illegal drug.4 The costs to society include drug-related crimes, accidents, lost productivity, increased health …

Special Project: Current Issues In Drug Enforcement Law, S. Douglas Williams, Jr.

Vanderbilt Law Review

The illegal drug trade and its costs to society have grown exponentially in the past several years. Drug traffickers, both within the United States and abroad, have amassed incredible wealth trafficking illicit drugs while the United States, the world's leading consumer of those drugs,' has suffered drug related increases in lost productivity, insurance costs, and health care expenditures. As the impact of these problems has reached more Americans, popular support for increased enforcement efforts has grown. Politicians have successfully used the drug war as a get-tough-on-crime campaign message. Local communities have organized themselves to confront drug dealers and to attempt …

Drug Proceeds Forfeiture And The Right To Counsel Of Choice, Danton A. Berube

Vanderbilt Law Review

As part of the current war on drugs, Congress enacted 21 U.S.C.section 853, the drug proceeds forfeiture statute. The statute authorizes criminal forfeiture of assets that are used in the commission of, or constitute the proceeds from, a federal drug felony. When prosecutors began to use the statute to seek forfeiture of defense counsel's attorney's fees, defendants and the law firms that represented them argued that the provision violated the sixth amendment right to counsel.

The courts of appeals were divided on the question of whether the sixth amendment prohibits forfeiture of assets intended to be used to hire an …

Cocaine, Demand, And Addiction: A Study Of The Possible Convergence Of Rational Theory And National Policy, A. Morgan Cloud, Iii

Vanderbilt Law Review

As the "war against drugs" meanders through the century,' policy-makers continue to search for effective strategies for combating the illegal drug industry. For seventy-five years the dominant federal strategy has been to curtail supplies of prohibited substances.' In its many permutations, this supply-side approach has included attempts to eradicate crops, to intercept drugs at the Nation's borders, and to arrest, prosecute, and punish commercial participants at every level of the production and distribution system.

By any rational measure, the supply-side "war against drugs" has failed. Only ten to fifteen percent of the illicit drugs entering the country are intercepted and …

Thoughts On A Faded Peacock: The Effect Of Erisa's Preemption Provision On State Third Party Prescription Drug Program Statutes, Richard M. Rindler, Evan Miller

Vanderbilt Law Review

This Article analyzes the preemptive effect of ERISA on state third party prescription drug program legislation. It argues that such laws do not "relate to employee benefit plans" and that even if the courts were to view them as relating to employee benefit plans, the laws meet the statutory exception to preemption for state laws that "regulate . . . insurance."

The Article contends that third party prescription drug program statutes represent a type of "borderline preemption problem, and it offers a functional approach to resolve the problem. If a state law affects employee benefit plans without infringing on their …

Truth In Judging: Supreme Court Opinions As Legislative Drafting, Ray Forrester

Vanderbilt Law Review

The first thesis this Article postulates is that the history of food and drug regulation during the past twenty centuries has been the history of the development of analytical chemistry, not the history of the development of law and regulation. Statutory law during this period has remained relatively static, while general understanding of analytical chemistry has leapt ahead with unparalleled achievement. Increased scientific enlightenment, largely achieved through analytical chemistry, has produced every important advance in food and drug regulation. Indeed, the overwhelming success of the field of analytical chemistry has created entire scientific disciplines as well as improvement in government …

Reducing Diet-Induced Cancer Through Federal Regulation: Opportunities And Obstacles, Richard A. Merrill

Vanderbilt Law Review

For more than a decade, federal health regulatory agencies have devoted major attention to controlling human exposure to substances believed capable of causing cancer. These efforts have evoked a broad spectrum of criticism; government has been accused of both indolence in the face of an incipient epidemic' and reckless distortion of science to support restrictions on substances that present only trivial risks. A central object of regulatory concern has been the safety of the food supply. At least since the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act),'with its famous Delaney Clause, the Food …

Measuring Risks And Benefits Of Food Safety Decisions, Richard Zeckhauser

Vanderbilt Law Review

This Article discusses the assessment of risks and benefits as one approach to organizing information.The way information is organized should depend on the way it will be valued and used. For example, the decision making authorities within the regulatory process may choose to take different approaches to food substances consumed by young and old, or rich and poor. In that case, information should be organized into those categories. An exquisite breakdown of consumption patterns by counties would do little for an age-regarding regulatory process.The remainder of this Article is divided into four parts. Part II reviews the general nature of …

Criminal Liability Of Corporate Officers For Strict Liability Offenses - Another View, Kathleen F. Brickey

Vanderbilt Law Review

This Article offers an alternative analysis of the doctrine articulated by the Supreme Court in Dotterweich and Park and its subsequent application by the Ninth Circuit. In the course of so doing, it suggests that Professor Abrams has lost sight of the public welfare offense model that provided the analytical framework within which the cases were decided and that his postulates may thus be faulted as lacking in context. The analysis in this Article demonstrates that the responsible share standard of liability has, from the outset, incorporated the requirement of an act or omission to act and that of causation …

Drugs And Criminal Responsibility, Edward H. Benton, Andrew Bor, William H. Leech, Joyce A. Levy, Samuel D. Lipshie, Thomas B. Mitchell, Gary M. Brown

Vanderbilt Law Review

This Special Project has carried out three broad purposes.First, it has synthesized and organized materials concerning drugs and criminal responsibility into a useful guide for legal practitioners and others interested in the problems of the drug dependent defendant. Second, it has identified serious analytical flaws in many of the defenses available to the criminal defendant. Finally,it has responded to these deficiencies with proposals intended to protect not only the legal rights of the drug dependent defendant but also the rights of society pertaining to criminal justice. While these societal interests include the swift imposition of criminal penalties when warranted, they …

Narcotics Offenders And The Internal Revenue Code: Sheathing The Section 6851 Sword, John M. Fite

Vanderbilt Law Review

This Note first will analyze the Internal Revenue Code provisions supporting the current crackdown by the IRS on suspected narcotics dealers. Secondly, it will examine the split in the federal circuit courts of appeal on the issues of the availability of Tax Court review of an assessment made pursuant to a section 6851 termination of a taxable year and the availability of equitable or statutory protections to prevent the seizure and sale of property belonging to the taxpayer. Lastly, a discussion of the propriety of such conduct by the IRS and its constitutionality in light of recent Supreme Court decisions …

The Delaney Anticancer Clause: A Model Environmental Protection Law, James S. Turner

Vanderbilt Law Review

In October 1969, the artificial sweetener cyclamate was banned from sale in the United States by Secretary of Health, Education, and Welfare Robert Finch. To justify his action legally Finch chose to rely'on the so-called Delaney Anticancer Clause of the Food, Drug, and Cosmetic Act of 1938. Consequently, the Delaney Clause, with its requirement that any substance producing cancer in animals be removed from the American food supply, became an immediate center of controversy. The Secretary himself criticized the Clause as an undue restriction on administrative decision making and as an unscientific limitation on scientific discretion.

The Fair Packaging And Labeling Act: Its Legislative History, Content, And Future, Wesley E. Forte

Vanderbilt Law Review

The Fair Packaging and Labeling Act (FPLA), which became effective on July 1, 1967, was designed to protect consumers by requiring informative labeling and nondeceptive packaging for consumer commodities. The statute has been described as "an information bill. The first part is information largely about the label .... The second part of the bill is really, in a way, to try to eliminate the confusion in words so we have a common terminology, so we all speak the same language.... It is like establishing an alphabet ... in size designations." The author seeks to provide an insight into the new …

The Legalization Of Marihuana: A Realistic Approach, Part I, Law Review Staff

Vanderbilt Law Review

All present indications point to an increase in marihuana use throughout the United States. Twenty-five years ago, the drug was found almost exclusively among the working class and minority groups, but the present trend has been toward increased use among people in the middle and upper income and social strata of society. As a result of this trend, the "marihuana problem" is gaining wide-spread prominence. More and more individuals, especially youth,are being subjected to the severe penalties associated with possession and use of marihuana. Not only are people becoming more aware of the legal punishments, but existing facts as to …

The Department Of Consumers, W. E. Forte

Vanderbilt Law Review

In 1872, Congress began protecting the American consumer by enacting legislation to prevent mail fraud. From this modest beginning, the consumer protection activities of the federal government have proliferated until today there are at least 33 government agencies engaged in 296 consumer protection activities. In 1961, the estimated annual expenditures by the federal government for direct consumer protection activities totaled 272 million dollars and the number of full-time federal employees engaged in such activities was almost 22,000. Expenditures for consumer advancement, a broader concept, were estimated at 681 million dollars in 1961 and the number of full time federal employees …

Federal Control In The Food And Drug Industries, Thomas W. Christopher

Vanderbilt Law Review

If the attention or lack of attention law reviews give to a subject is indicative of the amount of governmental control therein, then one would conclude that there is little federal regulation in the food and drug fields. The fact is, however, that there are more than 1,200 pages of federal statutes and administrative regulations affecting the food and drug industries, and no industry is more tightly controlled. The antitrust, securities, and labor statutes, for example, are, if anything, less stringent.

In the main, the approach of food and drug regulation is from a different point of view than that …