Volume 63 Issue 2
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Table of Contents
The Call for a New Approach
by
Joseph J. Leghorn, Partner in Nixon Peabody, LLP’s Product Liability Group, Boston, MA
Elizabeth Brophy, Associate in Nixon Peabody, LLP’s Product Liability Group, Buffalo, NY
Peter V. Rother, Deputy General Counsel and Chief Compliance Officer for AGA Medical Corporation, Plymouth, MN
63 Food and Drug Law Journal 391-406 (2008).
Ethical considerations regarding individual health and welfare need not be carelessly disregarded during creation of policies aimed at protecting the health of the population at large. Unintended adverse consequences for individuals or a smaller population should be considered before implementation of any law or regulations aimed toward the greater good of the public.
This article attempts to harmonize FDA’s goal of protecting the public health with a physician’s goal of caring for patients on an individual basis in the context of dissemination of information regarding off-label uses of medical products. Regulations of off-label speech should be guided by a recognition that physicians and regulators are working with different perspectives ― yet seeking to achieve the same goal ― improvements in human welfare.
The authors argue that flexible rather than strict interpretation and enforcement is a more ethical approach to protecting and promoting both individual and the public health.
by
Jordan Paradise, Associate Director of Research and Education of the Joint Degree Program in Law, Health & the Life Sciences, the University of Minnesota Law School in Minneapolis, MN
Gail Mattey Diliberto, a J.D. candidate, the University of Minnesota Law School in Minneapolis, MN
Alison W. Tisdale, an M.S. candidate in Chemical Engineering and Materials Science, the University of Minnesota in Minneapolis, MN
Efrosini Kokkoli, Assistant Professor of Chemical Engineering and Materials Science, the University of Minnesota in Minneapolis, MN
63 Food and Drug Law Journal 407-420 (2008).
“Nanotechnology” expands across research domains, applications and products and remains a field with neither a single scientific definition nor a formal regulatory or statutory definition. However, health and medical applications are burgeoning. This article examines the field of nanomedicine, highlighting existing products and future applications in the research and development phases.
The authors present existing oversight mechanisms for products in the drug and device realm, examine nanodrugs and nanodevices approved by FDA and highlight emerging nanoproducts that may pose challenges for current regulatory schemes in the United States and internationally.
by
Richard B. Goetz, Partner at O’Melveny & Myers LLP, Los Angeles, CA
Karen R. Growdon, Counsel at O’Melveny & Myers LLP, Los Angeles, CA
63 Food and Drug Law Journal 421-438 (2008).
The learned intermediary doctrine provides that a prescription drug manufacturer fulfills its duty to warn by providing an adequate warning of the medicine’s risks to the medical practitioner ― the “learned intermediary” ― who prescribes the medicine. The doctrine was first recognized in case law more than 50 years ago, and since that time has been recognized and applied in nearly all jurisdictions in the country.
In the last two decades, the marketing of prescription drugs directly to potential end-users through television, radio, print and internet advertising had grown significantly. Claimants in products liability cases now seek to hold prescription drug manufacturers liable for failing to include adequate warnings of prescription drug risks in their advertisements. Although the vast majority of jurisdictions continue to apply the learned intermediary doctrine, nine years ago, the highest court in one state fashioned an exception to the doctrine when a prescription drug has been advertised directly to consumers. And last fall the highest court of another state refused to adopt the rule altogether, in large part because some prescription drugs are now marketed directly to consumers.
This article examines the rationale for the learned intermediary doctrine and considers whether the doctrine is now outdated in light of the prevalence of direct-to-consumer advertising of prescription drugs. The authors conclude that, when a prescription medicine is obtained in the course of a physician-patient relationship, the rationale for applying the learned intermediary doctrine is still valid.
There is little evidence to suggest that patients no longer look to their physicians to evaluate the risks and benefits medicines in light of their patients’ specific medical needs. Prescription drug manufacturers are subject to stringent and detailed risk disclosure requirements applicable to the drug information that they provide physicians and to advertisements for prescription drugs directed to consumers. Engrafting on those existing requirements a new rule that permits juries to impose tort liability on manufacturers for failing to warn consumers directly of the risks of an advertised drug would be counterproductive from a policy and a practical standpoint.
A Step Toward Increasing Scientific Validity and Compassion
by
Alice K. Marcee, May 2008 J.D. candidate, Dedman School of Law Southern Methodist University, Dallas, TX
63 Food and Drug Law Journal 439-458 (2008).
In light of the Supreme Court’s recent denial of certiorari in the Abigail Alliance case, FDA and Congress have an opportunity to advance clinical trials towards a more scientifically sound and humane system.
This article supports ethical, scientific and policy arguments favoring expanded access by terminally-ill cancer patients to post-phase I investigational drugs.
The author concludes that expanded access does not preclude FDA’s continued regulation of these drugs or meeting its congressional mandate.
A New Approach to Justify FDA Regulation of These Prescription Drugs
by
Bruce Patsner, Research Professor in the Health Law & Policy Institute at the University of Houston Law Center, Houston, TX
63 Food and Drug Law Journal 459-492 (2008).
FDA’s recent decision to send warning letters to several pharmacies compounding prescription drugs for “bioidentical” hormone therapy is the latest round in a long-standing dispute between the Agency and the pharmacy profession over regulation of pharmacy compounding of prescription drugs. FDA has stated that it recognizes the essential role of compounding of prescription drugs in patient care, and is not interested in interfering with those pharmacies engaged in “traditional” compounding. Previous efforts to regulate compounding pharmacies have revolved around efforts to either classify such pharmacies as manufacturers, thus subject to FDA jurisdiction, or to simply argue that the compounded drugs are new drugs and thus subject to the NDA requirements of the Food, Drug, and Cosmetic Act. Federal courts have not readily embraced either approach.
Recent activities by several predominately Internet-based compounding pharmacies involving aggressive promotion of bioidentical hormone therapy to a national patient audience as an effective and safer wholesale replacement for established commercial prescription drugs. This article argues that this activity does not constitute compounding in the traditional sense and thus should be subject to FDA regulation. The article suggests new terminology and suggests a novel way of arguing for FDA regulation of this pharmacy activity that is not based on either the manufacturing or new drug arguments, and that would allow FDA to distinguish between those compounding pharmacies that are engaged in traditional compounding from those that are not.
by
Eric S. Nguyen, J.D. student, Harvard Law School, Cambridge, MA
63 Food and Drug Law Journal 493-508 (2008).
Each year, millions of consumers purchase diet products ranging from herbal supplements to meal replacement drinks. Companies like Weight Watchers and Jenny Craig devote tens of millions of dollars of their annual budget to advertising. At the center of much of the industry's marketing efforts are television advertisements featuring consumers who have experienced great success with such products. Concerned that these testimonials consistently mislead consumers, the Federal Trade Commission has suggested that it may promulgate more restrictive advertising guidelines. Industry watchers have suggested concrete revisions.
The most aggressive proposal would restrict advertisers to featuring only those consumers who have experienced “typical” weight-loss results. Other proposals call for companies to include in their advertisements a table of detailed statistics on typical weight loss.
This article argues that these leading proposals for change are overly broad and likely to be found unconstitutional under the First Amendment. It suggests that Congress and the Commission should instead devote greater resources to the post-market enforcement of the existing guidelines, which already require that testimonials be both representative of what consumers will generally achieve” and confirmed by “adequate substantiation.”
by
Drew A. Harker, Senior Partner in the Government Contracts and White Collar Criminal Defense Groups, Arnold & Porter LLP, Washington, DC
Chad E. Miller, Associate in the Government Contracts and White Collar Criminal Defense Groups, Arnold & Porter LLP, Washington, DC
63 Food and Drug Law Journal 509-524 (2008).
The U.S. Foreign Corrupt Practices Act (FCPA) prohibits improper payments by U.S. companies and others to foreign government officials to obtain or retain business. U.S. enforcement officials are devoting more resources to enforcing the statute and enforcement actions have significantly increased in the last several years. These enforcement activities have found new life with a recent federal appeals court decision giving the statute an expansive interpretation.
Given the scope of foreign government regulation of the pharmaceutical industry and the extent of drug company activity overseas, interaction with foreign government officials occurs at all levels of a drug’s life cycle and is on the rise. While most companies have focused their FCPA compliance efforts on traditional sales and marketing activity after a drug goes to market, FCPA risks also abound in connection with the conduct of research and development activities, such as clinical trials, in overseas locations, even before a drug is approved for sale.
The use of third parties, such as principal investigators, contract research organizations, and institutional review boards, creates particular risks of FCPA exposure for a number of reasons. First, payments by these third parties to foreign government officials can create FCPA exposure for U.S. sponsoring organizations, even if the U.S. company did not know about the payments. Second, given that the medical and research sector in many foreign countries is small, it is very possible that third parties retained to assist in a clinical trial will be covered government officials, including officials who make drug purchasing decisions for the foreign government. Payments to such officials raise issues under the FCPA. As a result, care should be taken to comply with the FCPA before engaging such third parties to be responsible for clinical trials.
The article concludes that FCPA compliance efforts should be extended to foreign clinical trial and research activity. These efforts should include separation of the research and development organizations from sales and marketing activity. In addition, due diligence should be conducted on all third parties retained to conduct clinical trials. These third parties should also receive training on FCPA compliance.
by
John D. Winter, Partner, Paterson Belknap Webb & Tyler LLP, New York, NY
63 Food and Drug Law Journal 525-536 (2008).
Federal regulations adopted 30 years ago prohibit sponsors of clinical studies from including waiver of liability provisions in informed consent documents.
The article concludes that, given recent regulations and statutes mandating greater diversity in patients involved in clinical studies and greater transparency regarding the results of ongoing studies, it my be appropriate to revisit the current regulation when the stated legal rationale for the regulation is analyzed.
by
Leah A. Satine, Associate in the law firm of Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., Washington, DC. She was the 2nd place winner in the 2007 H. Thomas Austern Memorial Writing Awards Competition―long paper
63 Food and Drug Law Journal 537-578 (2008).
As scientific understanding of human physiological processes has increased, so has the recognition that diet and health are closely related. The American population is constantly hearing media reports of scientific studies linking particular foods or food ingredients to various health effects. Such heightened consumer awareness of the correlation between food and wellbeing has not gone unnoticed by the food industry. Many foods are now being marketed as having health benefits beyond basic nutritional value. These “functional foods” claim a wide array of health benefits. Companies, however, may be too quick in their marketing, placing wellness claims on their labeling that science cannot confidently support. Despite government oversight of the food industry, unsupported claims may be rampant among functional foods because when subject to regulation as “conventional foods,” these products have little check on claim validity for the most common wellness claim — the structure/function claim. Though the Federal Food, Drug, and Cosmetic Act requires labeling to be “truthful and not misleading,” this standard is undefined and thus unenforceable for food labeling structure/function claims.
This paper fills the hole in the regulatory scheme by establishing the extent of scientific substantiation necessary for these claims to be “not misleading.” The development of the regulatory framework specifically focuses on yogurts, since this functional food’s enormous popularity can be attributed in large part to the marketing of digestive and immunological benefits of the probiotics in these yogurts. Applying the framework to a claim on one of the probiotic yogurts emphasizes the importance of the framework’s establishment since the analysis suggests that the claim may indeed be misleading in violation of the law.
by Andrew C. von Eschenbach, Commissioner of the Food and Drug Administration, Rockville, MD
63 Food and Drug Law Journal 579-584 (2008).
This article contains the prepared text of remarks delivered at the 51st Annual Conference of the Food and Drug Law Institute, March 26, 2008. The paper discusses the current state of FDA and the agency’s plans for addressing important issues in the future, including the Food and Drug Administration Amendments Act of 2007.
by
Gerald F. Masoudi, Chief Counsel, Food and Drug Administration, Rockville, MD
63 Food and Drug Law Journal 585-592 (2008).
This article contains the prepared text of remarks delivered at the 51st Annual Conference of the Food and Drug Law Institute, March 26, 2008. The paper discusses recent developments affecting FDA, including the Food and Drug Administration Amendments Act of 2007, Abigail Alliance and Riegel v. Medtronic.
Anticipating New Consumer Protection Challenges in the Food and Drug Marketplace
by
Lydia B. Parnes, Director of the Bureau of Consumer Protection at the Federal Trade Commission, Washington, DC
63 Food and Drug Law Journal 593-600 (2008).
This article contains the prepared text of remarks delivered at the 51st Annual Conference of the Food and Drug Law Institute, March 26, 2008. The paper discusses the direction of the FTC and its flexibility in adapting to emerging marketplaces.