Volume 54 Issue 1
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Table of Contents
> Remarks
of the Commissioner of Food and Drugs
> A
Message to the New FDA Commissioner
> The
History of the Public Health Service and the Surgeon General's
Priorities
> FDAMA
Update
> Structure/Function
Claims in Dietary Supplement Labeling:
Not All of These
Claims Need to Be Submitted to FDA and Accompanied in Labeling
by the DSHEA Disclaimer
> An
Overview From the Director of the Center for Food Safety
and Applied Nutrition
> The
New RAC: Restructuring of the National Institutes of Health
Recombinant DNA Advisory Committee
> The
SPS Agreement of the World Trade Organization and the International
Trade of Dairy Products
> Sublicense
or Supply Agreement? Supreme Court of Canada Interpretation
Benefits Generic Pharmaceutical Industry
> When
Unexpected Government Agents Drop In: Responding to Requests
for Immediate Interviews
> If
It's Regulated Like a Duck . . . Uncertainties in Implementing
the Patent Exceptions of the Drug Price Competition and
Patent Term Restoration Act
> Will
FDA Relinquish the "Gold Standard" for New Drug
Approval?
Redefining "Substantial Evidence" in
the FDA Modernization Act of 1997
> The
Potential for Self-Interested Behavior by Pharmaceutical
Manufacturers Through Vertical Integration
With Pharmacy
Benefit Managers: The Need for a New Regulatory Approach
Remarks
of the Commissioner of Food and Drugs
Author:
Jane E. Henney
Issue: 54 Food and Drug Law Journal 1-4 (1999).
In October
1998, Jane E. Henney was confirmed as the new Commissioner of Food
and Drugs. In this article, based on a presentation at FDLI's 42nd
Annual Educational Conference in December 1998, Dr. Henney discusses
the importance of leadership to the position of Commissioner of
Food and Drugs. Dr. Henney also lays out the priorities for her
tenure, including: the full and effective implementation of the
Food and Drug Administration Modernization Act (FDAMA); strengthening
the agency's science base; improving food safety and the safety
of the nation's blood supply; and tobacco.
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A
Message to the New FDA Commissioner
Author: Orrin
G. Hatch
Issue: 54
Food and Drug Law Journal 5-12 (1999).
In this article,
based on a presentation at FDLI's 42nd Annual Educational Conference
in December 1998, the Honorable Orrin G. Hatch welcomes Dr. Jane
E. Henney to the position of Commissioner of Food and Drugs. Senator
Hatch discusses several challenges that the Food and Drug Administration
likely will face in the coming years, including: the struggle to
provide the agency with adequate resources, facilities, and to maintain
a highly skilled staff; reviewing regulated products within statutory
timeframes; tobacco regulation; and dietary supplements. Senator
Hatch also briefly discusses upcoming congressional hearings on
the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman).
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The
History of the Public Health Service and the Surgeon General's Priorities
Author: David
Satcher
Issue: 54 Food and Drug Law Journal 13-20 (1999).
For two centuries,
the Public Health Service has had as its mission the goal of addressing
the health concerns of the nation's most vulnerable populations.
The PHS includes the Commissioned Corps, a part of the federal uniformed
services, but instead of using guns and missiles, it arms itself
with the weaponry of the best available science to secure and advance
the nation's health. Leading the charge have been sixteen Surgeons
General, who at times have had to essentially "wage war"
as they fought to protect the health of the nation. From the first
Surgeon General, John Woodworth, in 1871, who fought for quarantine
rights, all the way down to today, these leaders have come up against
very difficult political, social, and economic odds as they sought
to bring the best medical advice to the nation. Today, the Surgeon
General's priorities still focus on the health needs of the most
vulnerable populations. We have adopted as one of our top priorities
the elimination of racial and ethnic health disparities. To do that,
we see the need for this nation to move toward a balanced community
health system, consisting of health promotion, disease prevention,
early diagnosis and universal access to care. This system hopes
to achieve several goals: ensuring that every child has a healthy
start in life, promoting healthy lifestyles, and strengthening the
mental health system and removing barriers to access to care. In
addition, we recognize the need for the nation to maintain a global
perspective on issues of public health.
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FDAMA
Update
Author: Linda
A. Suydam & David K. Elder,
Issue: 54 Food and Drug Law Journal 21-34 (1999).
The Food and
Drug Administration Modernization Act of 1997 (FDAMA) is a sweeping
piece of legislation that impacts all significant areas of FDA regulation.
The law explicitly requires the agency to complete seventeen regulations,
eleven guidance documents, six regulatory notices, nine reports
and at least eighteen other tasks. The agency determined, however,
that substantially more tasks and activities are required than those
explicitly contained in the law. Through the extraordinary efforts
of many, and under the leadership of Commissioner Henney, considerable
progress is being made to implement both the letter and the spirit
of the law. Remarkably, the agency is progressing despite a chronic
erosion of funding that has led to a decrease in FDA employees.
One unique and significant aspect of FDAMA is a requirement to include
stakeholder feedback in the strategic planning process. Indeed,
stakeholders have seized the opportunity and contributed to the
transformation of FDAMA requirements into strategic directions that
will lead the agency into the new millennium. Modernization is an
ongoing and evolving process, to which the FDA is fully committed.
To ensure success, the agency recognizes the need for both stakeholder
input and congressional support.
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Structure/Function
Claims in Dietary Supplement Labeling: Not All of These Claims Need
to Be Submitted to FDA and Accompanied in Labeling by the DSHEA
Disclaimer
Author: Stephen
H. McNamara
Issue: 54 Food and Drug Law Journal 35-42 (1999).
"Structure/function"
claims in labeling are an important means of promoting dietary supplements.
The Dietary Supplement Health and Education Act of 1994 (DSHEA)
was intended to increase the freedom of dietary supplement labeling
to provide useful structure/function information. Too many companies,
however, unnecessarily notify the Food and Drug Administration (FDA)
about structure/function claims that do not require such notification
and unnecessarily use the statutory disclaimer to accompany those
claims in labeling. If a company possesses competent and reliable
scientific evidence that substantiates that its dietary supplement
helps support a normal, healthy structure or function of the body,
such a claim may be used properly in labeling without any notification
to FDA, and without use of the DSHEA disclaimer in labeling. The
author has observed the evolution of FDA's regulation of dietary
supplement labeling since the enactment of DSHEA, and offers several
conclusions about the current situation.
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An
Overview From the Director of the Center for Food Safety and Applied
Nutrition
Author: Joseph
A. Levitt
Issue: 54 Food and Drug Law Journal 43-48 (1999).
In February
1998, Joseph A. Levitt was appointed Director of the Food and Drug
Administration's Center for Food Safety and Applied Nutrition (CFSAN).
In this article, based on a presentation at FDLI's Food Regulatory
Update meeting in June 1998, Mr. Levitt provides a broad overview
of CFSAN — specifically, the values he hopes to instill throughout
the organization; the vision of CFSAN as a worldwide leader in food
safety; implementation of the President's Food Safety Initiative;
establishment of program priorities; and challenges the Center faces
in fulfilling its broad public health mission.
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The
New RAC: Restructuring of the National Institutes of Health Recombinant
DNA Advisory Committee
Author: Judith
E. Beach
Issue: 54 Food and Drug Law Journal 49-54 (1999).
The National
Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC)
was established in October 1974, in response to public concerns
regarding the safety of manipulation of genetic material through
the use of recombinant deoxyribonucleic acid (DNA) techniques. The
goal of the RAC is to consider the current state of knowledge and
technology regarding DNA recombinants and to recommend guidelines
for the conduct of recombinant DNA experiments. This article briefly
attempts to recount major changes to the RAC and their effects on
the procedures for submission of human gene transfer protocols.
Although the RAC has retained its role as a public forum for discussion
of issues relating to research proposals involving the deliberate
transfer of recombinant DNA into human subjects, its former responsibility
for approving specific human gene transfer protocols now lies with
the Food and Drug Administration, which retains statutory authority
for such approval. The RAC, however, continues to discuss and make
recommendations on novel or controversial gene therapy protocols.
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The
SPS Agreement of the World Trade Organization and the International
Trade of Dairy Products
Author: Terence
P. Stewart & David S. Johanson
Issue: 54 Food and Drug Law Journal 55-72 (1999).
The Agreement
on the Application of Sanitary and Phytosanitary Measures (SPS Agreement)
of the World Trade Organization (WTO) could bring significant changes
to the international trade of food and agricultural products. This
article examines the SPS Agreement and its possible impact on one
area of the food sector, the dairy industry. The SPS Agreement requires
that the health and safety measures of countries regarding imported
food and agricultural products be scientifically based, be supported
by risk assessments, and not operate as disguised barriers to trade.
As such, the SPS Agreement could facilitate the international trade
of dairy products by removing scientifically unfounded trade barriers.
The article briefly describes the provisions of the SPS Agreement
as they affect the dairy industry, examines the three disputes that
have to date reached WTO panels, and discusses certain disputes
involving dairy products that might be resolved in the future through
the SPS Agreement.
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Sublicense
or Supply Agreement?
Supreme Court of Canada Interpretation Benefits
Generic Pharmaceutical Industry
Author: Sheldon
Burshtein
Issue: 54 Food and Drug Law Journal 73-92 (1999).
The Supreme
Court of Canada rarely considers intellectual property, licensing,
or drug regulatory cases. In two decisions involving three related
cases, however, the court found an agreement between Canada's two
largest generic drug manufacturers to be a supply agreement rather
than a sublicense. Amendments to the Patent Act in 1993 eliminated
Canada's compulsory licensing regime. Apotex and Novopharm, however,
hold numerous valuable compulsory licenses that were grandfathered
and still have many years to run; those licenses expressly prohibit
sublicensing. Apotex and Novopharm agreed that if either held a
compulsory license, that party would supply the others' requirements.
If the agreement constituted a sublicense, the licensors could terminate
the licenses, which would have been disastrous to the generic pharmaceutical
industry. In its decisions, the court expressed views on the right
of a licensee to grant a sublicense, what constitutes a sublicense,
and the right of one who acquires a patented drug to further formulate
it into a dosage form. The court also commented on Canada's unique
scheme of tying regulatory approval of a patented drug to patent
legislation. The decisions provide insight into the chess-like battle
in Canada between innovators and generics, a game involving statutory
and regulatory amendment, litigation, and contractual arrangements.
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When
Unexpected Government Agents Drop In: Responding to Requests for
Immediate Interviews
Author: Steven
M. Kowal
Issue: 54 Food and Drug Law Journal 93-110 (1999).
The first line
of defense in a complex criminal investigation often must be provided
by lawyers who do not practice criminal law. Many formal investigations,
including those conducted by the Food and Drug Administration's
Office of Criminal Investigations, often are commenced with unannounced
"ambush" interviews of potential targets; executives often
are contacted in the office or at home without prior notice. These
initial interviews afford the government enormous advantages. Executives
do not want to appear uncooperative, and are uncertain of their
rights and obligations. There will not have been an opportunity
to prepare or to review relevant documents before responding to
important questions. Answers that are ill-considered or incomplete
can fuel the investigation, and in some instances can support separate
criminal charges. The peril of such interviews extends to the attorney
who advises the executive; charges for obstruction of justice can
be premised on advice that is motivated by a "corrupt"
purpose. Because the government seems to have increased its pursuit
of these cases, the most effective response is education and preparation
long before such an investigation is commenced. Executives must
understand the importance of this encounter and realize that they
have choices — the interview cannot be compelled. Lawyers must
be aware of the potential ramifications of the advice they convey.
Without this degree of preparation, an "ambush" interview
could ensnare both the executive and the lawyer.
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If
It's Regulated Like a Duck . . . Uncertainties in Implementing the
Patent Exceptions of the Drug Price Competition and Patent Term
Restoration Act
Author: David
J. Bloch
Issue: 54 Food and Drug Law Journal 111-126 (1999).
The Drug Price
Competition and Patent Term Restoration Act (DPCPTR Act) extended
the patent terms of products subject to substantial premarket regulatory
delay because of FDA approval requirements. It also created an exception
to the general rules of infringement so that competitors may prepare
for FDA review of their own products before a pioneer's patent term
expires. Although this new exemption from infringement initially
was understood to apply only to drugs, court decisions have extended
it to medical devices as well. In applying the statute in this context,
fundamental questions have arisen as to what devices are eligible
for the DPCPTR Act exceptions and the type of activities that will
be excepted from infringement. While consensus has been achieved
in some areas, ambiguities and disagreement remain.
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Will FDA Relinquish the "Gold Standard" for New Drug Approval?
Redefining "Substantial Evidence" in the FDA Modernization Act of 1997
Author: Jennifer Kulynych
Issue: 54 Food and Drug Law Journal 127-150 (1999).
Section 505(d)
of the Federal Food, Drug, and Cosmetic Act defines the legal standard
of proof for new drug effectiveness. Pursuant to section 505(d),
a sponsor must provide the Food and Drug Administration (FDA) with
"substantial evidence" that a new drug is effective. Prior
to 1997, section 505(d) defined substantial evidence as "evidence
consisting of adequate and well-controlled investigations, including
clinical investigations." FDA has interpreted section 505(d)
as a mandate to require, under normal circumstances, two independent
clinical trials for proof of effectiveness. This two-trial requirement
has long been the source of controversy, and with the passage of
the Food and Drug Administration Modernization Act of 1997 (FDAMA),
the statutory definition of "substantial evidence" was
amended. Section 115 of FDAMA now permits one-trial approvals, at
the Secretary's discretion. This article will examine political
and scientific issues surrounding the "substantial evidence"
debate, and the differing expectations of FDA and the industry as
the agency begins to implement section 115 of FDAMA.
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The
Potential for Self-Interested Behavior by Pharmaceutical Manufacturers
Through Vertical Integration With Pharmacy Benefit Managers: The
Need for a New Regulatory Approach
Author: Elizabeth
L. Mitchell
Issue: 54 Food and Drug Law Journal 151-184 (1999).
Pharmacy benefit managers (PBMs) arose in the 1980s as claims processors of pharmaceutical benefits. While they continue to serve this function, they have added the function of helping third-party payers and providers contain their overall pharmaceutical expenses. In this role, PBMs have a significant influence on the demand for and usage of pharmaceuticals. Recognizing this influence, pharmaceutical manufacturers have sought long-term contracts, partial ownership interests, and parent-subsidiary relationships with PBMs. While PBMs advance managed care's goal of cost-effectiveness, vertical integration between PBMs and pharmaceutical manufacturers may compromise this objective.
Vertical integration
facilitates unjustified preferences for the products of the aligned
manufacturer that simultaneously may produce higher prices and reduce
the quality of medical care. This article explores three avenues
of federal regulation that evince an interest in promoting pure
market outcomes and preventing illicit market behavior — the
anti-kickback statute, antitrust law, and FDA regulation. Concluding
that these regulatory models do not address a vertically-integrated
manufacturer's ability to bias the cost-effectiveness decisions
of an associated PBM, the article recommends federal regulation
directed specifically at these vertical arrangements.
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