Volume 60 Issue 1
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Table of Contents
> Lessons from Expanded Government Enforcement Efforts Against Drug Companies
by Marc J. Scheineson, head of the food and drug practice in the Washington, D.C. office of Alston & Bird LLP, and a former FDA Associate Commissioner
and
Shannon Thyme Klinger, Partner in the Washington, D.C. office of Alston & Bird LLP. Her practice focuses on the defense of healthcare fraud and abuse matters, with an emphasis on matters arising under the Civil False Claims Act
> Perception and Process at the Food and Drug Administration: Obligations and Trade-Offs in Rules and Guidances
by Erica Seiguer, an M.D.-Ph.D. candidate in the Doctoral Program in Health Policy at Harvard University and Harvard Medical School, Boston, MA
and
John J. Smith, Counsel at Hogan & Hartson, L.L.P., Washington, DC, and Advisor to Regulatory Affairs, Center for Integration of Medicine and Innovative Technology (CIMIT), Boston, MA
> Takings Issues in the Approval of Generic Biologics
by John C. Yoo, Professor of Law, University of California at Berkeley School of Law (Boalt Hall), Berkeley, CA, and a visiting scholar at the American Enterprise Institute.
> Medical Research on Humans: Regulation in Switzerland, the European Union, and the United States
by Markus Schott, Lic. iur. 96', Dr. iur. '00, LL.M. '04 (Harvard), and an attorney at law at Wenger Plattner, Basel, Switzerland.
> The World Health Organization's Prequalification Program and its Potential Effect on Data Exclusivity Laws
by David Childs, a 2005 J.D. candidate at The Florida State University College of Law.
A previous version of this article won First Place in the Food and Drug Law Institute's 2003-2004 H. Thomas Austern Memorial Writing Awards Competition (short papers).
Lessons from Expanded Government Enforcement Efforts Against Drug Companies
Authors: Marc J. Scheineson and Shannon Thyme Klinger
60 Food and Drug Law Journal 1-16 (2005).
As Food and Drug Administration (FDA) enforcement actions related to the promotion of pharmaceuticals have ebbed in the last five years, other government agencies have willingly filled the vacuum. Investigations have increased dramatically by the Office of the Inspector General for the Department of Health and Human Services and by state attorneys general. Recent actions are based on expansive new interpretations of the federal Anti-Kickback Statute, False Claims Act, Prescription Drug Marketing Act, and state consumer protection laws. The authors use their experience defending these claims to review and analyze the trends, summarize existing law and cases, review the criteria used by the government to evaluate new cases, and counsel companies about how to prepare for, and survive, this increased government scrutiny.
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Perception and Process at the Food and Drug Administration:
Obligations and Trade-Offs in Rules and Guidances
Authors: Erica Seiguer and John J. Smith
60 Food and Drug Law Journal 17-32 (2005).
Rulemaking has become increasingly complex as government agencies must cope with the twin challenges of multiple constituencies and intense time pressures. A commonly-held perception inside and outside the Food and Drug Administration (FDA) is that rulemaking is both time-consuming and resource-intensive, and this perception is believed to impact decisionmaking processes. In particular, FDA is seen by many as having turned to guidance documents, which represent a less formal means of communicating the agency's position on a wide range of issues.
This article examines rulemaking and guidance development at FDA, the perception of agency officials and FDA's various constituencies of these processes, the factors involved in choosing whether to pursue formal rulemaking or less formal controls, and the trade-offs represented by these choices. It also examines how rulemaking and guidance development takes place, providing appropriate examples to illustrate key points. The research presented suggests that agency officials are aware of the tension between rule and guidance development, and that there is an overall perception—confirmed by data analysis—that guidances are being used more frequently than notice-and-comment rulemaking.
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Takings Issues in the Approval of Generic Biologics
Author: John C. Yoo
60 Food and Drug Law Journal 33-44 (2005).
Recent efforts to streamline the Food and Drug Administration's (FDA's) drug approval processes include a proposal to rely on proprietary data supplied by branded companies in consideration of subsequent generic applications. In response, some brand-name industry sources have argued that such a practice might run afoul of the U.S. Constitution. For a variety of reasons, however, the proposed regulatory change would not constitute an unconstitutional taking of property in violation of the Fifth Amendment.
Brand-name pharmaceutical companies do not possess "reasonable, investment-backed expectations," regarding their previous submissions of data to FDA. While trade secrets are obviously protected by the Fifth Amendment, the internal agency use of these secrets surely is not. So long as FDA merely references innovator-submitted data for its own internal safety and effectiveness determinations, without publicly releasing innovator trade secrets, the proposed FDA procedure change is safe from constitutional attack. It should be evaluated solely on the basis of policy, not legal, arguments.
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Medical Research on Humans: Regulation in Switzerland, the European Union, and the United States Author: Markus Schott
60 Food and Drug Law Journal 45-78 (2005).
This article provides an overview of the regulations governing the conditions for clinical trials on an international level including the Nuremberg Code , the Declaration of Helsinki, the Convention on Biomedicine of the Council of Europe and the Guidelines of CIOMS (Council for International Organizations of Medical Science) and ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), as well as the regulations in Switzerland, the European Union, and the United States.
The general comparison of the different regulations reveals three common features: the high and increasing level of precision, the trend towards international harmonization, and the close interaction between state and private actors. With regard to substantive issues, the basic conflict between the public's interest in effective medical research and the conflicting interest of the human research subjects in the promotion and protection of their health requires careful balancing. Informed consent and the correlation of risks and benefits as well as approval by institutional review boards or ethics committees have become internationally recognized standards. Special groups of research subjects (i.e., children, incapacitated adults, pregnant or breastfeeding women, prisoners and military personnel), research in emergency situations, and placebo studies still pose normative problems that are handled quite differently by the various national and international regulations.
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The World Health Organization's Prequalification Program and its Potential Effect
on Data Exclusivity Laws
Author: David W. Childs
60 Food and Drug Law Journal 79-98 (2005).
The World Health Organization (WHO) developed a Prequalification Program that screens multisource pharmaceutical products for safety and efficacy approval without requiring the submission of a product dossier; instead, the manufacturer must show therapeutic equivalence to a referenced pharmaceutical product. WHO developed the program to increase access to effective treatment in the disease-plagued, impoverished nations of Africa. WHO does not require any lag period between the domestic approval of an innovative drug and the Prequalification Program's approval of its multisource counterpart, which typically originates in India or other developing nations. The upcoming years likely will witness the program's exponential growth, and consumer confidence in the safety and efficacy of drugs originating in countries such as India similarly will increase. Enhanced access to safe, inexpensive generic drugs in developing nations will increase the illegal importation of generic drugs into industrialized nations and will heighten the political pressures on the governments of industrialized nations to relax data exclusivity laws and thus facilitate access to generic medications.
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