DTC Prescription Drug Advertising: The History and Impact of FDA Regulation

This paper traces the history of direct-to-consumer (DTC) advertising for prescription drugs in the United States, beginning with the enactment of the Federal Food, Drug, and Cosmetics Act in 1938 and continuing through the current state of FDA regulation. A detailed analysis of how the promulgation of DTC ads has affected a variety of groups (including consumers, the medical profession, pharmaceutical companies, the government, and advertisers) is followed by a brief look at a well-known DTC ad campaign (Schering-Plough’s Claritin). The paper questions whether DTC ads are a constructive or a deconstructive element of the American healthcare system and concludes by offering an opinion on the current state of DTC advertising regulation and enforcement by the FDA

Paradise Found? Food Transportation Regulation: A Detour Through Regulatory Purgatory

On January 31, 2014, the Food and Drug Administration ( FDA ) issued a Notice of Proposed Rulemaking ( NPRM ) that would set requirements for shippers, carriers and receivers of food transported in intrastate and interstate commerce. The NPRM marks a potentially important step in a long history of the (non-)regulation of food transportation. In Parts I and II, this paper will provide some context of the history of food transportation, as well as the major incidents that placed the food transportation industry on the regulatory map. In Parts III and IV, the paper will consider the history of food transportation regulation from the Food, Drug and Cosmetics Act ( FDCA ) to the most recent NPRM. Finally, in Part V, the paper will consider the potential efficacy of the NPRM from the standpoint of its ability to correct market failures

Do Off-Label Drug Practices Argue Against FDA Efficacy Requirements? Testing an Argument by Structured Conversations with Experts

The Food, Drug and Cosmetics Act of 1938 with amendments in 1962 is inconsistent regarding FDA certification of a drug’s efficacy. The act requires efficacy certification for the drug’s initial (“on-label”) uses, but does not require certification before physicians may prescribe for subsequent (“off-label”) uses. Are there good reasons for this inconsistency? Using a sequential online survey we carried on a “virtual conversation” with some 500 physicians. The survey asked whether efficacy requirements should be imposed on off-label uses, and almost all physicians said no. It asked whether the efficacy requirements for initial uses should be dropped, and most said no. We then gently challenged respondents asking them whether opposing efficacy requirements in one case but not the other involved an inconsistency. In response to this challenge we received hundreds of written commentaries. This investigation taps the specialized knowledge of hundreds of physicians and organizes their insights into challenges to the consistency argument. Thus, it employs a method of structured conversations with experts to test the merit of an argument. Is the consistency argument a case of “foolish consistency,” or does it hold up even under scrutiny?Food and Drug Administration; drug approval; efficacy requirements; off-label uses; on-label uses; certification; liberalization

Regulating the Export of Unapproved Drugs

Prior to 1986, it was not possible under the Federal Food Drug and Cosmetics Act to export drugs which did not have FDA approval. The law was changed by the Drug Export Amendments Act of 1986 after nearly a decade of debate. Those who favored liberalizing the drug export law argued that American companies were at a competitive disadvantage in foreign markets because of the prohibitions, and the pharmaceutical industry suffered as a result. They argued that the national sovereignty of those countries that decided that unapproved drugs were appropriate for use by their citizens should be respected, and that it would be excessively paternalistic to deny these countries the products they desired. Those who opposed lifting the ban on exporting unapproved drugs argued that economic concerns were not sufficient to overcome the ethical difficulty in creating a double standard which allowed drugs that had not been determined safe and effective for use by U.S. citizens to be used by the citizens of foreign nations

Cosmetic Crisis: The Obsolete Regulatory Framework of the Ever-Evolving Cosmetic Industry

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 for cosmetics has expanded drastically, and consumers use more products daily. Further, scientific advancements now reveal the safety or danger of chemicals within the products. Given the multitude of studies indicating the presence of dangerous chemicals latent in cosmetics, the regulatory system requires modernization. Unfortunately, legislators consistently fail to pass legislation to regulate the industry and protect cosmetic consumers. Do legislators still consider the cosmetic market too inconsequential to regulate? This Note advocates for stricter cosmetic regulations, discusses alternative means of regulation reform, and evaluates the likelihood of legislators enacting such reform

FQPA IMPLEMENTATION TO REDUCE PESTICIDE RESIDUE RISKS: PART II: IMPLEMENTATION ALTERNATIVES AND STRATEGIES

Implementation of the Food Quality Protection Act (FQPA) is fraught with difficulty due to the divergent perspectives and demands of stakeholders in the process. In "Part I: Agricultural Producer Concerns," the authors reviewed the concerns of food producers about potential FQPA threats to farm profitability, international competitiveness, consumer perceptions, and the development of pest resistance to remaining pesticides. Fortunately, lessons from past environmental policy and economic theory offer useful principles for how to implement the FQPA. This paper, "Part II: Implementation Alternatives and Strategies" addresses ways to accommodate producer concerns while meeting the policy mandate of reducing risk from pesticide exposure, especially for infants and children. In so doing, the authors are neither advocating nor criticizing this FQPA policy mandate; rather, they are providing policy analysis of alternative implementation strategies.Crop Production/Industries, Food Consumption/Nutrition/Food Safety,

Got Controversy - Milk Does

This article analyzes ongoing controversy over how to best label rBST-free milk. Recombinant bovine somatotropin is a genetically engineered drug administered by some farmers to their dairy herds to increase milk production. FDA first approved its use in 1994, despite great controversy. The FDA also issued labeling guidelines that allowed voluntary disclosure of rBST-free milk, so long as it carried the disclaimer that no difference could be detected between milk produced with rBST and rBST-free. The controversy continues today as consumers express a preference for rBST-free milk and many rBST-free producers label their milk this way. Conventional milk (with rBST) is viewed by the FDA as materially the same as rBST-free. So, conventional producers have continually challenged marketing that is meant to convey rBST free milk is superior or more nutritious. This article specifically analyzes the recent activities surrounding rBST - an FTC petition, an FDA petition to withdraw rBST approval, and several states\u27 rulemaking and legislation to tighten rBST-free labeling. One of the state\u27s rules has also spawned federal litigation. The article recommends that stakeholders must generate consumer survey data to understand the effect of rBST labels on consumers, and then use that data to design better milk labels