FDLI Publications: Food and Drug Law Journal 61-4

Volume 61 Issue 4

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Any questions or concerns regarding this policy change should be directed
to Michael Levin-Epstein, FDLI's Editor-in-Chief.

> Presumption of Innocence: FDA's Authority to Regulate the Specifics of Prescription Drug Labeling
and the Preemption Debate

by Howard L. Dorfman, Vice President-Assistant General Counsel, Bayer HealthCare LLC, West Haven, CT. The views expressed in the article are those of the author(s) and do not necessarily reflect those of Bayer HealthCare

and

Vivian M. Quinn, Partner in Nixon Peabody LLP’s Products Liability Group, Boston, MA, New York, NY and Buffalo, NY

and

Elizabeth A. Brophy, Associate with Nixon Peabody LLP’s business litigation and pharmaceutical and medical device teams

> The Food and Drug Administration's Evolving Regulation of Press Releases: Limits and Challenges
by William W. Vodra, Partner in the Pharmaceutical and Medical Technology practice group of Arnold & Porter LLP, Washington, D.C. The views presented are those of the author

and

Nathan G. Cortez, Associate in the Pharmaceutical and Medical Technology practice group of Arnold & Porter LLP, Washington, D.C. The views presented are those of the author

and

David E. Korn, Assistant General Counsel with the Pharmaceutical Research and Manufacturers of America (PhRMA). He was Counsel to Arnold & Porter LLP, Washington, D.C., when this article was written. The views presented are those of the author

> When You Have a Hammer Everything Looks Like a Nail: Misapplication of the False Claims Act to Off-Label Promotion
by Ralph J. Hall, Visiting Associate Professor of Law at the University of Minnesota. He also serves as counsel to the Indianapolis law firm of Baker & Daniels. This firm represents a number of drug and device companies including Zimmer Holdings, Inc

and

Robert J. Berlin, Joint-degree student in law and public health (epidemiology) graduating in 2007

> Is Noerr-Pennington Immunity Still a Viable Defense Against Antitrust Claims Arising from Hatch-Waxman Litigation?
by Esther H. Steinhauer, Counsel in the New York office of Hunton & Williams LLP. The views expressed here are the personal views of the author and do not necessarily reflect those of her firm or the firm’s clients

> FDA v. Ephedra: Is It Time to Lift the Ban?
by Kenneth R. Pyle, 2006 graduate (cum laude) of Widener University School of Law in Wilmington, DE

> What Will it Take to Reap the Clinical Benefits of Pharmacogenomics?
by Barbara J. Evans, Director of the Program in Pharmacogenomics, Ethics, and Public Policy at the Indiana University Center for Bioethics; Research Professor of Medicine in the Indiana University Department of Medicine, and Visiting Professor of Law at the Indiana University Law School, Indianapolis, IN

> Enhancing Risk Management at ORA
by Margaret O’K. Glavin, Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs, the Food and Drug Administration. These remarks were s presented at the Food and Drug Law Institute’s (FDLI’s) 49th Annual Conference on April 6, 2006

> Science, Ethics and Economics in FDA Decision-Making: The Legal Framework
by Richard M. Cooper, Partner in the law firm of Williams & Connolly LLP, Washington, D.C. He represented the sponsor of the contraceptive drug, Plan B. The views expressed here are his own and do not necessarily reflect the views of that sponsor. This article is from a speech given at FDLI’s 49th Annual Conference in April 2006

> Protecting FDA’s Ability to Protect Public Health
by Michael R. Taylor, Professor, School of Medicine, University of Maryland. This article is the presentation made by Mr. Taylor at a panel discussion, What Role Should Scientific, Ethical and Economic Issues Play in FDA's Decisionmaking Process , which t took place at FDLI's 49th Annual Conference, “Celebrating the Centennial of the 1906 Pure Food and Drug Act,” April 5-7, 2006, in Washington, D.C.

> Ethics and FDA
by John Fielder, Professor Emeritus at Villanova University, Villanova, PA

Presumption of Innocence: FDA’s Authority to Regulate the Specifics of Prescription
Drug Labeling and the Preemption Debate

Authors: Howard L. Dorfman, Vivian M. Quinn, & Elizabeth A. Brophy

61 FOOD AND DRUG LAW JOURNAL 585-622 (2006).

This article examines the regulatory framework for labeling of pharmaceutical drugs and the debate that has erupted as a result of the Food and Drug Administration’s explicit interpretation of the preemptive effect of its 2006 Rulemaking for Labeling Requirements.
The FDA position has become the focus of intense debate, renewing the arguments between proponents and critics of preemption that have led to wide divergence of opinions and inconsistent appellate court rulings. The article traces the legal history of the preemption issue relating to pharmaceutical products and provides an analysis of the justification for its general adoption as a means to promote the societal benefit of providing scientifically reliable information to healthcare providers and the public.

The Food and Drug Administration’s Evolving Regulation of Press Releases: Limits and Challenges

Authors: William W. Vodra, Nathan G. Cortez, David E. Korn
61 FOOD AND DRUG LAW JOURNAL 623-651 (2006).

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising. Over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.
Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency’s approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. The agency has had to adjust its approach to account for First Amendment concerns and resource limitations, which has led FDA to cooperate with the Securities and Exchange Commission (SEC), and take more creative responses to allegedly violative press materials.

This article discusses how FDA has regulated press materials in the past, and how recent developments may signal new directions in the agency’s regulatory approach. The article proposes a framework for evaluating whether FDA might assert jurisdiction, and what the “rules” are if it does. The article considers the legal theories behind FDA’s approach and the implications for manufacturers.

When You Have a Hammer Everything Looks Like a Nail: Misapplication of the False Claims Act to Off-Label Promotion

Authors: Ralph J. Hall, Robert J. Berlin
61 FOOD AND DRUG LAW JOURNAL 653-677 (2006).

The federal government has collected literally billions of dollars alleging, among other claims, that off-label promotion of drugs and devices violates the False Claims Act (FCA). The huge potential penalties in these cases have led to their settlement and no court has yet fully tested the viability of the legal theory linking off-label promotion to FCA liability. This article assesses this theory and concludes that generally there should be no liability under the FCA for off-label promotion.

The basic legal theory underlying these cases is that a company’s illegal off-label promotion leads physicians to prescribe these products and then to seek reimbursement from the government for prescription of off-label products. Companies generally are unaware of whether doctors are seeking reimbursement through the government, or in some cases, whether the product will be prescribed off-label. Further, it is perfectly legal for doctors to prescribe off-label products, and, in some cases, .it is perfectly legal for physicians to seek reimbursement for these products.

This article argues that the lack of a nexus between the actions of the manufacturer and the substance and legality of the ultimate reimbursement submission negates the conclusion that a violation of the off-label promotion rules leads to liability under the FCA.

Is Noerr-Pennington Immunity Still a Viable Defense Against Antitrust Claims Arising from Hatch-Waxman Litigation?

Author: Esther H. Steinhauer

61 FOOD AND DRUG LAW JOURNAL 679-700 (2006).

It has become common that, ancillary to patent litigation initiated under the Hatch-Waxman Act, antitrust claims will be filed against one or more of the pharmaceutical manufacturers involved in the litigation, usually in subsequent class action suits. Almost any activity connected with Hatch-Waxman litigation can be (and has been) charged with giving rise to antitrust violations, often in concert with allegations of “sham” litigation. One defense to these charges is that the allegedly improper activities are protected from antitrust scrutiny under the Noerr-Pennington doctrine.

This article discusses several activities connected with Hatch-Waxman litigation that have been charged with giving rise to antitrust violations and the applicability of Noerr-Pennington protection, including associated uncertainties and risks. In particular, the article looks at: fraud allegations in connection with the issuance of a patent, largely governed by the Walker-Process exception to Noerr-Pennington protection; allegations of misrepresentations in connection with listing of patents in the “Approved Drug Products with Therapeutic Equivalence Evaluations,” or Orange Book; allegations of “sham” litigation in connection with the initiation and pursuit of Hatch-Waxman litigation and whether such suits were “objectively baseless”; and allegations that settlement of litigation was improper and entered into for the sole purpose of preventing generic competition.

The article also considers whether and how the 2003 Amendments to the Hatch-Waxman Act may impact the Noerr-Pennington defense, and concludes by recommending some practical steps to reduce antitrust risk.

FDA v. Ephedra: Is It Time to Lift the Ban?

Author: Kenneth R. Pyle
61 FOOD AND DRUG LAW JOURNAL 547-558 (2006).

In April 2004, FDA's Final Rule banning the sale and marketing of dietary supplements containing ephedra and ephedrine alkaloids went into effect, thus preventing consumer access to what has been called “the oldest medicinal plant in continuous use.”

Nutraceutical, a manufacturer of dietary supplements containing ephedra, challenged FDA's Final Rule in federal district court and won. The court held that FDA's use of a risk-benefit standard in deciding to ban ephedra was “improper” under the Food, Drug and Cosmetic Act (FDCA). FDA appealed to the Tenth Circuit Court, and a three-judge panel reversed, ruling that the risk-benefit standard was permissible under the FDCA. Nutraceutical has since appealed the decision to the full Tenth Circuit Court.

This article advocates the affirmation of the district court's earlier decision that overturned FDA's Final Rule and charged FDA with further rulemaking consistent with the FDCA's “dose-specific” standard rather than a risk-benefit standard. The district and circuit court decisions, as well as other relevant cases, are examined, leading to the conclusion that FDA's ban of ephedra does not have a firm legal and scientific basis and should be lifted in favor of a more reasonable approach, such as warning labels, to address any safety concerns regarding the use of ephedra. The legislative history of the Dietary Supplement Health and Education Act (DSHEA) also is analyzed to show that Congress never intended to give FDA the discretion to ban dietary supplements, which are foods, using a risk-benefit standard applicable to drugs and medical devices. A consideration of FDA's consistently negative policy toward dietary supplements in favor of pharmaceuticals is also presented to help the reader see why the right of consumers to have access to natural, alternative methods of addressing their health needs is ultimately at risk and must be preserved.

What Will it Take to Reap the Clinical Benefits of Pharmacogenomics?

Author: Barbara J. Evans
61 FOOD AND DRUG LAW JOURNAL 753-794 (2006).

Genetically targeted drug and biologic therapies promise a new era of personalized medicine, but there has been frustration with how slowly these therapies are moving from concept to actual clinical application. Various legal and regulatory barriers threaten to delay translation of basic discoveries into approved products and to slow the clinical uptake of new therapeutic products as they become available. There is a pressing need to reach consensus on what these barriers are, so that they can be addressed in a timely and effective manner.

This paper explores what some of the key barriers may be. It examines: (1) legal, regulatory, and commercial barriers to “successive improvement” of existing drugs through improved targeting strategies; (2) barriers to cooperative, multi-party development of targeted therapies; (3) methodological problems in assessing the incremental health and economic benefits of an improved targeting strategy; (4) limitations of traditional product labeling as a medium for communicating timely, clear information about drug targeting to clinicians and the need to create new mechanisms within the medical profession to manage and communicate this information; and (5) difficulty defining the appropriate line between regulation of medical products and regulation of medical practice, in the case of targeted therapies.

Enhancing Risk Management at ORA

Author: Margaret O’K. Glavin
61 FOOD AND DRUG LAW JOURNAL 795-798 (2006)

Pharmaceutical and medical device litigation has risen dramatically in the last 20 years in Canada, due mainly to the increased access to the courts afforded to plaintiffs.

This article is an edited version of the prepared text of remarks delivered at the 49 th Annual Conference of the Food and Drug Law Institute, April 7, 2006. The speech discussed the commitment of FDA's Office of Regulatory Affairs to enhance its use of science-based risk management policies.

Science, Ethics and Economics in FDA Decision-Making: The Legal Framework

Author: Richard M. Cooper
61 FOOD AND DRUG LAW JOURNAL 799-803 (2006).

This article is an edited version of the prepared text of remarks delivered at the 49 th Annual Conference of the Food and Drug Law Institute, April 7, 2006. The speech discussed several significant legal provisions relating to the application of science in administering the Federal Food, Drug, and Cosmetic Act.

Protecting FDA’s Ability to Protect Public Health

Author: Michael R. Taylor
61 FOOD AND DRUG LAW JOURNAL 805-808 (2006).

This article is an edited version of the prepared text of remarks delivered at the 49 th Annual Conference of the Food and Drug Law Institute, April 7, 2006. The speech asserted that FDA's job is to protect and promote public health by regulating the safety, effectiveness and proper labeling of products within its jurisdiction, in accordance with standards established by law and advocated that the agency discipline itself to stay within this role.

Ethics and FDA

Author: John H. Flelder
61 FOOD AND DRUG LAW JOURNAL 809-810 (2006).

This article is an edited version of the prepared text of remarks delivered at the 49 th Annual Conference of the Food and Drug Law Institute, April 7, 2006. The speech maintained that FDA is charged with protecting the health based on science, not the public morality, based on some ethical or religious conception.