Volume 57 Issue 2
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Table of Contents
> The Safe Harbor Provision
of the Hatch-Waxman Act: Present Scope, New Possibilities, and International
Considerations
by Brian D. Coggio, Senior Partner in the law firm of Pennie &
Edmonds LLP,
New York, NY
F. Dominic Cerrito, Partner in the law firm of Pennie & Edmonds
LLP,
New York, NY.
> Alternative Dispute Resolution in the Advertising
Industry: The Role of Government Regulation in the National Advertising
Review Council Ad Review Process
by R. Bruce Dickson, Partner in the law firm of Paul, Hastings,
Janofsky & Walker LLP, Washington, D.C.
> Coordination of Federal Regulation and Payment for
New Diagnostic Tests: A Proposed New Approach
by Michele Schoonmaker, Ph.D., U.S. Food and Drug Administration.
At the time this article was written, she was Director of Medical
Reimbursement and Government Affairs for Vysis, Inc., in Downers
Grove, IL
Grant P. Bagley, M.D., J.D., Partner in the law firm of Arnold
& Porter, Washington, D.C., and former Director of the Coverage
and Analysis Group in the Health Care Financing Administration's
Office of Clinical Standards and Quality
M. Kay Scanlan, J.D., formerly was an Associate in the law firm
of Arnold & Porter, Washington, D.C. and now consults for
the drug and device industry.
> Overview of Canadian Privacy Law for Pharmaceutical
and Device Manufacturers Operating in Canada
by Erika King, Assistant General Counsel at PhRMA, Washington,
D.C.
When this article was written, she was an associate with the law
firm of Covington & Burling, Washington, D.C.
John H. Fuson, Associate with the law firm of Covington &
Burling, Washington, D.C.
> The Food and Drug Law Institute's 45th Annual Educational Conference Keynote Addresses
by Orrin G. Hatch (R-UT), U.S. Senate
Lester M. Crawford, Jr., Food and Drug Administration Deputy Commissioner
Daniel E. Troy, Food and Drug Administration Chief Counsel
Sheila F. Anthony, Federal Trade Commission Commissioner
Alex M. Azar, II, General Counsel, Department of Health and Human
Services
> The Hatch-Waxman Act: Balancing Competing Interests
or Survival of the Fittest?
by Kristin E. Behrendt, Associate at the law firm of Darby &
Darby, P.C., New York, NY. A previous version of this article
won first place in the FoxKiser Annual Writing Competition in
Law, Science & Medicine in 2001.
> Fluoxetine-Induced Suicidal Ideation: An Examination
of the Medical Literature, Case Law, and the Legal Liability of
Drug Manufacturers
by Andrew E. Falsetti, Pharm.D., Cornell Law School, Ithaca, NY.
> Advising Under the Influence?: Conflicts of Interest
Among FDA Advisory Committee Members
by Elizabeth R. Glodé, Associate in the law firm of Fredrikson
& Byron, PA, Minneapolis, MN.
> PBMs: Ripe for Regulation
by Regina Sharlow Johnson. The original form of this article was
submitted by the author as her graduate thesis for a Masters in
Health Law degree from the Widener Law School Health Law Program. > Is the Fox Guarding the
Henhouse? Who Makes the Rules in American Nutrition Policy?
by Emily J. Schaffer, Associate at the law firm of Paul, Weiss,
Rifkind, Wharton & Garrison in New York, NY.
The Safe Harbor Provision of the Hatch-Waxman Act:
Present Scope, New Possibilities, and International Considerations
Author: Brian D. Coggio & F. Dominic Cerrito
Issue: 57 Food and Drug Law Journal 161-176 (2002).
The article summarizes the history of the safe harbor provision of the Hatch-Waxman Act, with particular emphasis on recent applications and developments. The article also discusses procedural aspects of the safe harbor defense in litigation as well as means for alleged infringers to avoid the safe harbor and test the validity of patents that would otherwise impede commercialization. Lastly, the article provides an overview of the safe harbor provision or its counterpart in various foreign countries.
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Alternative Dispute Resolution in the Advertising Industry:
The Role of Government Regulation in the National Advertising Review Council Ad Review Process
Author: R. Bruce Dickson
Issue: 57 Food and Drug Law Journal 177-194 (2002).
Disputes over allegations of false or misleading advertising have become common in the marketplace for both prescription and over-the-counter drugs. A frequently-used alternative forum for such disputes is provided by the National Advertising Division (NAD) of the Council of Better Business Bureaus. Advertisers whose ads are challenged before the NAD have sought to avoid NAD review by arguing that prior Food and Drug Administration (FDA) review provides an imprimatur sufficient to preempt a false advertising challenge. In several recent cases, the NAD has examined the limits of deference to agency review, making clear that it is only where the agency has approved or required specific language in ads that blind deference is appropriate. Where that criterion is not met, the NAD will occasionally defer, but will not abdicate its responsibility to review advertising claims independently and to recommend changes where claims are not adequately substantiated. This article reviews NAD cases and Lanham Act court decisions to examine the role of deference to FDA and other agency review in private advertising challenges.
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Coordination of Federal Regulation and Payment for New Diagnostic Tests: A Proposed New Approach
Author: Michele Schoonmaker, Grant P. Bagley & M. Kay Scanlan
Issue: 57 Food and Drug Law Journal 195-204 (2002).
Technical advances in healthcare are clinically useful only if they
are available, yet availability is typically slowed until the technology
is reimbursed by insurers. Payment facilitates access. Food and Drug
Administration (FDA) approval is often necessary for new products (e.g.,
new laboratory tests) to enter the marketplace, but is not sufficient
to obtain third-party coverage. Private insurers and public programs
such as Medicaid and Medicare increasingly demand further evidence of
the clinical utility of a new test before providing coverage, although
private insurers and government agencies often lack explicit criteria
for developing coverage and payment policies for laboratory tests. The
difficulty in designing adequate clinical trials during the FDA approval
process that will also meet insurers' requirements leads to an unexpected
hurdle; sponsors often mistakenly expect to gain reimbursement based
on FDA's determination that the technology is "safe and effective."
Efficient technology evaluation should assess not only safety and effectiveness,
but also the clinical utility (i.e., medical necessity) and added value
of new laboratory tests. Redundancy in the system should be eliminated;
methods of evaluation need to be standardized; and criteria for coverage
should be clarified to decrease the cost of assessment, maximize the
utility of information generated, stimulate further innovation, and
increase patient access to new beneficial laboratory tests. This article
explores a model that supports the potential for federal agencies, manufacturers,
and professional organizations to facilitate efficient new technology
assessments. The model could be applied to new genetic tests without
excessive overhaul of existing agency oversight structures.
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An Overview of Canadian Privacy Law for Pharmaceutical and Device Manufacturers
Operating in Canada
Author: Erika King & John H. Fuson
Issue: 57 Food and Drug Law Journal 205-226 (2002).
In 2001, Canada enacted the Personal Information Protection and Electronic
Documents Act (PIPEDA). PIPEDA establishes rights to the protection
of personal information collected, retained, used, or disclosed in the
course of commercial activities, and imposes obligations on organizations
that collect, retain, use, and disclose such information. Important
features of PIPEDA include the following: it applies retroactively to
information collected prior to its effective date; organizations subject
to its provisions will be held responsible for violative uses and disclosures
by subsequent transferees; and the Canadian Privacy Commissioner may
initiate wide-ranging audits on the strength of complaints by anyone,
including a competitor. This article provides an overview of PIPEDA
for pharmaceutical and device manufacturers operating in Canada.
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The Food and Drug Law Institute's 45th Annual Educational Conference Keynote Addresses:
Summaries or Remarks
Author: Orrin G. Hatch (U.S. Senate)
Lester M. Crawford, Jr. (FDA Deputy Commissioner),
Daniel E. Troy (FDA Chief Counsel), Sheila F. Anthony (FTC Commissioner), and Alex M. Azar, II (General Counsel Department of Health and Human Services)
Issue: 57 Food and Drug Law Journal 227-246 (2002).
These are summaries and prepared remarks of several individuals who
participated as speakers at the Food and Drug Law Institute's (FDLI's)
45th Annual Educational Conference in Washington, D.C. on
April 16-17, 2002. The Food and
Drug Law Journal has long served the archival purpose of documenting
a variety of meeting presentations. The institutional objective in publishing
these summaries is, of course, to convey the speakers' messages to the
Journal readership, but it is also to preserve those messages
in a fixed-point repository of information that may be referenced by
researchers in the future.
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The Hatch-Waxman Act: Balancing Competing Interests or Survival of the Fittest?
Author: Kristin E. Behrendt
Issue: 57 Food and Drug Law Journal 247-272 (2002).
The Hatch-Waxman Act, an amendment to the Federal Food, Drug, and
Cosmetic Act, was passed primarily to ease the approval process for
generic drugs. The Act also granted patent extensions to drug patent
owners denied patent term exclusivity because of a lengthy FDA review
process. The Act intended to benefit consumers, generic drug companies,
and brand name innovator drug companies. Strategic maneuvering by generics
and innovators, however, has skewed the intended purpose of the act.
Several areas of controversy also have emerged based upon interpretation
of the language of the Act. This article discusses the events prompting
creation of the Act, areas of controversy emerging from strategic maneuvering
tactics, and areas of controversy materializing from the language of
the Act. This article also explores the impact of the Act on the pharmaceutical
industry and the general public.
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Fluoxetine-Induced Suicidal Ideation:
An Examination of the Medical Literature, Case Law, and the Legal Liability of Drug Manufacturers
Author: Andrew E. Falsetti
Issue: 57 Food and Drug Law Journal 273-292 (2002).
Case reports of fluoxetine-induced suicidal ideation have appeared
in the medical literature since the early 1990s. Many studies and meta-analyses
thereafter have cast considerable doubt on the existence of any connection
between fluoxetine and the other selective serotonin reuptake inhibitors
and the emergence of suicidal ideation or behavior. Nonetheless, patients
or their families have filed a multitude of lawsuits against drug manufacturers.
This article examines the medical literature, the tort law applicable
to drug products liability actions, and issues and trends that have
emerged in the suits against drug manufacturers.
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Advising Under the Influence?: Conflicts of Interest Among FDA Advisory Committee Members
Author: Elizabeth R. Glodé
Issue: 57 Food and Drug Law Journal 293-322 (2002).
This article addresses the difficulties faced by the Food and Drug
Administration (FDA) as it attempts to locate "independent"
experts to serve on drug and biologics advisory committees. As academic
medical experts grow more dependent on private sources of funding, it
is increasingly difficult for FDA to find scientists and physicians
who are qualified to serve on committees and who can meet the agency's
financial conflict of interest requirements. To cope with this problem,
FDA has developed a system of waivers, allowing experts to serve on
advisory committees if the need for their services outweighs the dangers
posed by potential conflicts of interest. But waivers cannot resolve
the underlying conflict, even if they provide the agency with a means
of managing the problem. Consumer advocates, members of Congress, and
the press have accused FDA of approving dangerous drugs or vaccines
after relying on the recommendations of conflicted advisory committee
members. This article traces the development of FDA's methods for evaluating
experts' financial conflicts and considers whether the agency's current
policies do enough to protect the integrity of the advisory committee
process.
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PBMs: Ripe for Regulation
Author: Regina Sharlow Johnson
Issue: 57 Food and Drug Law Journal 323-370 (2002).
Current legislative proposals regarding the addition of prescription drug benefits to traditional Medicare envision an active role for pharmacy benefit management companies (PBMs). This article focuses on PBMs—their likely role in healthcare reform; how they operate and turn a profit; their pitfalls, particularly the lack of regulation of this industry; and the aspects of the industry that potentially violate federal law, including the False Claims Act, the Anti-Kickback Act, and RICO. The article concludes with a call for further regulation of PBMs before they are empowered with control over Medicare prescription drugs.
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Is the Fox Guarding the Henhouse? Who Makes the Rules in American Nutrition Policy?
Author: Emily J. Schaffer
Issue: 57 Food and Drug Law Journal 371-412 (2002)
This article explores the conflicts that have emerged as the federal government has tried to balance its varied and often inconsistent roles as regulator, educator, and provider in the context of evolving social, economic, and scientific conditions. It focuses on the historic alliance between the agricultural industry and government agencies charged with promoting public health, and how that alliance has been challenged by the shift in emphasis away from diseases associated with scarcity and toward diseases of nutritional excess. The article argues that the failure to question this alliance's continuing validity in an era of plenty has rendered policy makers unduly susceptible to the influence of food industry lobbyists. The article begins with a discussion of the case PCRM v. Glickman to illustrate how the nutritional interests of the American public may not be well served by government agencies charged with both encouraging healthful dietary habits and promoting American agricultural products. It presents an overview of today's conflicts; explores the history of nutrition policy in America; and articulates the conclusion that in order to promote optimal nutrition, the government must fundamentally rework its current nutrition policy to develop a more coherent policy whose primary concern is the health of the American public.
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