Volume 62 Issue 2
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Table of Contents
> What Are Biologics? A Comparative Legislative, Regulatory and Scientific Analysis
by Edward L. Korwek, is a Senior Partner with the law firm of Hogan & Hartson LLP, Washington, DC. Any views expressed herein are solely those of the author and do not necessarily reflect those of Hogan & Hartson or any of its clients. The author sincerely thanks Shelley Castle, Mary Dennis, Joan Kohout and Connie See for their thorough legislative and regulatory history research and Katherine Danish for her excellent assistance in the preparation of this article
> Your Business in Court ― 2006
by John B. Reiss, Partner & member of the Health Law and Life Sciences Practice Groups, Saul Ewing LLP, Philadelphia, PA
and
Mark C. Levy, Partner in the Litigation Department and Chair, Life Sciences Litigations and Risk Containment Practice Subgroup, Saul Ewing LLP, Philadelphia, PA
and
Christopher R. Hall, Partner and member of the White Collar and Corporate Investigations Practice Group, Saul Ewing LLP, Philadelphia, PA
and
Gregory J. Wartman, Associate in the Litigation Department and member of the Life Sciences Litigation and Risk Containment Practice Subgroup, Saul Ewing LLP, Philadelphia, PA
> Pharmaceutical Global Marketing Practices: Increased Scrutiny Ahead
by Elizabeth I, Hack, Partner in the law firm McDermott Will & Emery LLP, Washington, D.C. where she is a member of the Firm’s Health Law Department. Ms. Hack represents global pharmaceutical manufacturers in matters involving government law enforcement as well as providing regulatory advice and counseling
> Monosodium Glutamate (MSG) and Food Labeling Regulations
by Amy Lavine, student at Albany Law School
> Disclaimers in Dietary Supplement Print Advertising:
The Bodybuilding Category as a Model Case for Change
by R. William Soller, Health Sciences Clinical Professor of Pharmacy and Executive Director of the Center for Consumer Self Care, UCSF School of Pharmacy, San Francisco, CA
and
Lorie G. Rice, Assistant Health Sciences Clinical Professor and Associate Dean of External Affairs, UCSF School of Pharmacy, San Francisco, CA
and
Peter J. Ambrose, Professor of Clinical Pharmacy and Vice Chair, Department of Clinical Pharmacy, UCSF School of Pharmacy, San Francisco, CA
> New Dietary Ingredient Notifications: A Comprehensive Review and Strategies for Avoiding FDA Objections
by Ashish R. Talati, Partner at Amin Hallihan, LLC, Chicago, IL
> The Case for Preemption of Prescription Drug Failure-to-Warn Claims
by Christine H. Kim, received her J.D. in 2007 from the University of Virginia School of Law. She was the second place winner in the 2005-2006 H. Thomas Austern Memorial Writing Awards short paper Competition. The author would like to thank Professor Richard Merrill for his invaluable assistance in writing this article and Dr. Monica Krieger for her mentorship in the regulatory affairs arena
> State of the FDA
by Andrew C. von Eschenbach, Commissioner of the Food and Drug Administration. This is the text of his prepared remarks at the 50th FDLI Annual Conference in Bethesda, MD, April 12, 2007, co-sponsored by FDLI and FDA
> New FDA Guidance Documents
by Sheldon T. Bradshaw, Chief Counsel, Office of the Chief Counsel, the Food and Drug Administration. His remarks were presented at the Food and Drug Law Institute/FDA Annual Educational Conference on April 12, 2007, in North Bethesda, MD
> Food for Thought: The FTC and Market Influences on Consumer Health
by Deborah Platt Majoras, Chairman, Federal Trade Commission (FTC). These remarks were presented as the Luncheon Address at the 50th Annual FDLI & FDA Educational Conference on April 12, 2007, Washington, D.C. The views expressed herein are those of the author and do not necessarily represent the views of the FTC or any other Commissioner
> Legal Developments Relevant to FDA Authority
by Daniel Meron, General Counsel, Department of Health and Human Services. This was his address at the 50th FDLI/FDA Annual Educational Conference in North Bethesda, MD, April 12, 2007
What Are Biologics? A Comparative Legislative, Regulatory and Scientific Analysis
Author: Edward L. Korwek
62 Food and Drug Law Journal 257-304 (2007).
The statutory provisions defining human and veterinary biologics have very similar legislative histories. Their implementation, however, often has been quite different, resulting in regulations covering a wide variety of diverse products. There are several reasons for the differences. Two federal agencies are involved, and a variety of technological developments have posed definitional challenges. The coverage of regulations, therefore, have been stretched in assorted and sometimes contradictory ways. Moreover, the scientific and regulatory complexities and nuances of the definitions themselves frequently defy attempts at defining their exact scope. These and other considerations explain why descriptions of the types of products that are biologics often are inaccurate, especially on the human side.
This article chronologically tracks the major changes in the definitions for human and veterinary biologics in the last 100 years. It also analyzes and compares the criteria for human and veterinary biological product status, particularly in the context of scientific and medical advancements related to the treatment of infectious diseases, gene and cell therapies, tissue engineering and cloning.
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Your Business in Court ? 2006
Authors: John B. Reiss, Mark C. Levy, Christopher R. Hall and Gregory J. Wartman
62 FOOD AND DRUG LAW JOURNAL 305-342 (2007).
This article reviews major legislative changes and agency and court decisions affecting pharmaceutical, medical device and biotechnology companies.
Review of the fraud and abuse decisions and settlements for 2006 demonstrate the high risk of substantial penalties and fines resulting from adverse jury verdicts, which emphasizes why companies tend to settle rather than fight. The article points out compliance requirements imposed on companies as a result of the Deficit Reduction Act of 2005, and reviews jurisdictional decisions that suggest whistleblowers may have increased difficulty receiving payment for their efforts.
It appeared that the FTC’s merger reviews in 2006 were focused more on the markets where purchases of health care products and services take place, and less on the markets involving the purveyors of services and products to the merging companies. The FTC is trying vigorously to diminish the effectiveness of patent litigation settlements between brand name and generic manufacturers that postpone entry of generic drugs into the market, though with little success at present. Finally, the FTC continues to take a strong position in attacking misleading and deceptive sales of drugs, devices and related products. The SEC continues to be concerned with the effect of companies’ misleading statements on their stockholders’ interest, whether such statements are affirmative misrepresentations or omissions of material facts. The SEC continues to investigate and penalize insider trading, and violations of the Foreign Corrupt Practices Act.
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Pharmaceutical Global Marketing Practices: Increased Scrutiny Ahead
Author: Elizabeth I. Hack
62 FOOD AND DRUG LAW JOURNAL 343-348 (2007).
On January 1, 2007, the International Federation of Pharmaceutical Manufactures and Associations (IFPMA) enacted an updated version of the Code of Pharmaceutical Marketing Practices (Code) to address the ethical promotion of pharmaceutical products internationally.
This article looks at whether the implementation of the updated Code will increase the level of scrutiny of international sales and marketing practices and if this will affect the daily operations of multinational pharmaceutical companies. In addition, the article compares and contrasts the IFPMA Code to the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Care Professionals (PhRMA Code) and highlights the new obligations placed on pharmaceutical companies operating abroad.
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Monosodium Glutamate (MSG) and Food Labeling Regulations
Author: Amy Lavine
62 FOOD AND DRUG LAW JOURNAL 349-374 (2007).
This article deals with food labeling, consumers’ right to know and various other issues sparked by food information debates through examining the treatment of an especially contentious food additive, MSG.
Included in the article is a short history of MSG and its place within the American regulatory framework, a description of the controversy surrounding the additive and a discussion of the costs and benefits connected to heightened food labeling requirements. The discussion is intended to highlight some of the food labeling issues that are likely to attain greater importance as food production technologies continue to become more complex.
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Disclaimers in Dietary Supplement Print Advertising:
The Bodybuilding Category as a Model Case for Change
Authors: R. William Soller, Lorie G. Rice and Peter J. Ambrose
62 FOOD AND DRUG LAW JOURNAL 375-386 (2007).
Voluntary use of disclaimer statements for structure/function (S/F) claims in dietary supplement print advertisements from bodybuilding magazines was assessed based on a cross-sectional sample of magazines having total circulation of 2.4 million.
Few advertisements provided references for clinical studies. Only a minority had disclaimer statements, and these were given poor prominence through location, type size, and other formatting. None were linked directly to S/F claims. Print advertisements in this category have limited fair balance to their claims. The findings support rectifying the legal disparity in use of disclaimers on print advertisements and product labels.
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New Dietary Ingredient Notifications: A Comprehensive Review and Strategies
for Avoiding FDA Objections
Author: Ashish R. Talati
62 FOOD AND DRUG LAW JOURNAL 387-398 (2007).
In the last three years, FDA’s acceptance rate of New Dietary Ingredient Notifications (NDINs) has decreased dramatically. Out of the about 43 notifications fi led in 2006, only three were accepted by FDA — less than 10 percent.
The NDIN is a vehicle used by companies to bring to market new dietary ingredients not marketed in the United States prior to October 15, 1994. The safety of the new dietary ingredient is determined by FDA on a reasonable expectation of safety basis. However, some in industry assert that FDA has reviewed NDINs through the prism of food additive petitions and, in turn, objected to the majority of NDINs for lack of safety data.
This article provides a comprehensive review of the NDIN process and suggests strategies for filing successful NDINs.
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The Case for Preemption of Prescription Drug Failure-to-Warn Claims
Author: Christine H. Kim
62 FOOD AND DRUG LAW JOURNAL 399-422 (2007).
FDA recently announced in the preamble to a new rule on prescription drug labeling that any agency-approved labeling preempts state tort claims. Critics claim that this practice allows the President to bypass both Congress and notice-and-comment rulemaking to achieve “silent tort reform.” Moreover, they argue, FDA’s preamble violated the procedural requirements of both the Administrative Procedure Act and an executive order on federalism and that judicial deference is unwarranted.
This article defends FDA’s preamble as both sound law and policy under the doctrine of implied preemption. It draws upon Supreme Court precedent to show that FDA has the authority not only to preempt state law impliedly through regulations, but also to evince its preemptive intent in a regulatory preamble. Furthermore, it maintains, FDA’s preamble complied with all relevant procedural requirements. Finally, it asserts that even though Chevron deference does not apply, the preamble is still entitled to strong judicial deference under an alternative line of cases.
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State of the FDA
Author: Andrew C. von Eschenbach
62 FOOD AND DRUG LAW JOURNAL 423-428 (2007).
This article contains the prepared text of remarks delivered at the 50th Annual Conference of the Food and Drug Law Institute, April 12, 2007. The speech discussed the current issues facing the Food and Drug Administration and FDA’s planned response to those challenges.
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New FDA Guidance Documents
Author: Sheldon T. Bradshaw
62 FOOD AND DRUG LAW JOURNAL 429-432 (2007).
This article is an edited version of remarks delivered at the 50th Annual Conference of the Food and Drug Law Institute, April 12, 2007. The paper discusses FDA’s enhanced enforcement role involving unapproved drug products in the following categories: drugs with potential safety risks; drugs that lack evidence of effectiveness; drug being fraudulently promoted; and drugs that present a direct challenge to the new drug approval process.
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Food for Thought: The FTC and Market Influences on Consumer Health
Author: Deborah Platt Majoras
62 FOOD AND DRUG LAW JOURNAL 433-440 (2007).
This article contains the prepared text of remarks delivered at the 50th Annual Conference of the Food and Drug Law Institute, April 12, 2007. The paper discusses FTC’s role in tackling childhood obesity and consumer fraud.
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Legal Developments Relevant to FDA Authority
Author: Daniel Meron
62 FOOD AND DRUG LAW JOURNAL 441-444 (2007).
This article contains the prepared text of remarks delivered at the 50th Annual Conference of the Food and Drug Law Institute, April 12, 2007. The paper analyzed two landmark cases impacting food and drug law: Abigail Alliance v. von Eschenbach and Medical Pharmacy v. Gonzales.
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