Volume 64 Issue 3
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Table of Contents
Regulations for Off-Label Promotion Prosecutions
by
Gregory Gentry, Associate at the law firm of Morrision Mahoney, LLP, Boston, MA
64 Food and Drug Law Journal 441-458 (2009).
Your company has spent months designing a compliance program and training your sales representatives. They know never to mention the off-label uses of your product. If they are asked about the off-label uses by the physician they are detailing, they know to forward those inquiries to the scientific liaisons at headquarters. But, could your company still be in legal jeopardy simply because it knows that the product is being used for an off-label purpose? This article attempts to track the Food and Drug Administration’s (FDA’s) shifting interpretation of its “intended use” regulations, from focusing entirely on the statements of the manufacturers to focusing on the knowledge of the industry, indeed, of the consumers of products, in determining the true intended use of a product. It will look at several recent attempts by FDA to use that new interpretation of the regulations to expand its power: to regulate tobacco and to require pediatric indications for any new drug. Finally, it will look at several recent examples of how this new interpretation has manifested in actions by FDA and the Department of Justice (DOJ).
by
James T. O’Reilly, Professor, College of Law, University of Cincinnati, Cincinnati, OH
64 Food and Drug Law Journal, 459-472 (2009).
Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now “regulate” very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers’ continued sales, working at the margins, arranging the paperwork for protection of megafirms’ market share, and sitting by as the deaths and addictive behaviors continue. “Join the Public Health Service, inspired by a public health mission,” they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility.
This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.
American Consumers
by
Jennifer E.F. Butler, 2009 Graduate of the Lewis & Clark School of Law, Portland, OH
64 Food and Drug Law Journal 473-502 (2009).
Animal cloning is “a complex process that lets one exactly copy the genetic, or inherited, traits of an animal.” In 1997, Dolly the sheep was the first animal cloned and since then “scientists have used animal cloning …. to breed dairy cows, beef cattle, poultry, hogs and other species of livestock.” Cloned animals are highly attractive to livestock breeders because “cloning essentially produces an identical copy of an animal with superior traits.” The main purpose of cloning livestock is “more focused on efficiency and economic benefits of the producer … rather than the overall effect of cloning on an animal’s physical and mental welfare.”
The focus of this article is threefold. First, the science behind animal cloning is explained and some potential uses and risks of this technology are explored. Second, FDA’s historical evolution, current regulatory authority, and limitations of that authority, is described. Lastly, a new regulatory vision recognizes the realities of 21st century global markets and the dynamic evolution of scientific discovery and technology.
by
Ashish R. Talati, Partner and Chair of the Food and Drug Law Practice Group at Amin Talati, LLC, Chicago, IL
Abhishek K. Gurnani, First Year Associate at Amin Talati, LLC, Chicago, IL
64 Food and Drug Law Journal 503-514 (2009).
The Food and Drug Administration (FDA) works actively to ensure that all the dietary supplements currently in the market are safe for the public. Existing policies are often remodeled and new regulations are developed periodically. A recent change to supplement regulations includes the implementation of a system that allows consumers to contact the FDA or product manufacturer directly to report an adverse reaction as a result of dietary supplement consumption. FDA has employed an adverse event reporting (AER) system that is aimed to police postmarketing effects of dietary supplements.
This article will shed light on the importance of tracking serious adverse events with respect to dietary supplements that have already been marketed. Using this data, dietary supplement companies will be able to take the necessary steps to ensure that their products remain safe for the public by removing problematic ingredients from their products and engaging in more effective labeling and product disclaimer practices.
Health Policy Encounters Administrative Law
by
Michael S. Kolber, Law Clerk to the Hon. Amalya L. Kearse, U.S. Court of Appeals for the Second Circuit Court
64 Food and Drug Law Journal 515-530 (2009).
Medicare is the public health insurance program for elderly and disabled Americans. Established in 1965, today it is the primary health insurer for more than 40 million people. Like all insurance programs, Medicare must determine what benefits to cover. In the Medicare statute, Congress established coverage for broad categories of care—hospitalization, office visits and prescription drugs—and broad categories that were excluded, such as vision and dental care. Beyond these broad categories, Congress left the agency administering Medicare—now known as the Center for Medicare and Medicaid Services (CMS)—to determine whether certain treatments are “reasonable and necessary” and thus eligible for Medicare coverage.
Two “facts” about Medicare coverage determinations are well established in the health policy literature. First, CMS does not have criteria by which it makes coverage decisions. Second, CMS does not conduct cost effectiveness analysis in making these determinations. Although CMS approves coverage of most treatments it is asked to evaluate—99 percent of the time in one study—it does deny coverage of some procedures and devices. Therefore, some criteria for denying coverage must exist, even if they are not published or otherwise formalized. This article demonstrates that, as both a legal and policy matter, these explanations are inadequate.
by
Esther W.B. Bleicher, General Attorney, Office of the Chief Counsel, the Food and Drug Administration, Office of the Commissioner, Rockville, MD
64 Food and Drug Law Journal 531-564 (2009).
In September 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Title III of the FDAAA, the Pediatric Medical Safety and Improvement Act (Title III), created new incentives, mandates, Food and Drug Administration (FDA) authority and funding with the aim of increasing the availability of devices for pediatric populations while assuring the safety and effectiveness of those devices. This article describes the complex problem Title III addresses and situates Title III within the context of the regulatory scheme previously in place, particularly in relation to the one in place to address the parallel problem for pediatric drugs, and the concerns and policy recommendations of diverse stakeholders voiced leading up to Title III.
by
Haitham M. Ahmed, holds an MPH from Harvard School of Public Health, Boston, MA
64 Food and Drug Law Journal 565-576 (2009).
Regulations have historically been able to shape public behavior in various ways. As poor dietary practices and obesity continue to pose major health and economic threats to society, attention will continue to be directed towards the ethical and legal responsibilities of fast food manufacturers as potential contributors to these problems. In light of these considerations, several opportunities emerge that may impact dietary behavior and obesity through regulation of the fast food industry. This article addresses the health consequences of fast food consumption, as well as the historical and legal contexts of fast food regulation in the United States.
by
Sarah Taylor Roller, Partner in the law firm of Kelley Drye & Warren LLP, Washington, DC
Raqiyyah R. Pippins, Associate in the law firm of Kelley Drye & Warren LLP, Washington, DC
Jennifer W. Ngai, Associate in the law firm of Kelley Drye & Warren LLP, Washington, DC
64 Food and Drug Law Journal 577-598 (2009).
This article provides a summary of the expansion of FDA’s discretionary authority in the post-9/11 period, particularly with respect to FDA’s authority to monitor and publicize potential health risks linked to food, dietary supplements, nonprescription drugs, and other consumer health products. In addition, this article evaluates the need for FDA to establish procedural safeguards to reduce the significant risks of unintended and undue harm to people and regulated companies that can result from adverse publicity in the more “transparent” post 9/11 FDA regulatory environment. Specifically, Part I summarizes the amendments to the FDCA enacted during the post-9/11 period that have expanded FDA’s postmarket authority to monitor, evaluate, and publicize potential health risks linked to food, dietary supplements, nonprescription drugs and other consumer health products marketed in the United States, in conjunction with FDA’s Sentinel Initiative, Reportable Food Registry, and other adverse event reporting requirements.
Part II discusses the convergence of FDA’s expanded postmarket authority to publicize product-related risks with President Obama's transparency initiative aimed at fostering “open government” through increased public access to government information. In addition, Part II considers the nature of the procedural safeguards needed in the post-9/11 FDA regulatory environment, in view of FDA’s historical record and illustrative cases that help expose how adverse “transparency” surrounding FDA warning letters, recalls and safety alerts concerning products in the marketplace can have undue and unintended prejudicial and harmful effects for the people and companies that are legally responsible for such products. Finally, based on these analysis, this article concludes with some observations concerning the nature of the procedural safeguards needed to reduce the significant risks of “transparency” policy harms in the pos-9/11 regulatory environment.