Volume 59 Issue 2
FDLI has initiated a policy regarding the Food and Drug Law Journal online: Only the Table of Contents and article abstracts for each issue will be posted to our website. Visitors can obtain a full text version of an entire issue. Your purchase will be processed quickly, and at reasonable rates.
Any questions or concerns regarding this policy should be directed to
Michael Levin-Epstein, FDLI's Editor-in-Chief.
Table of Contents
> Remarks of the Acting FDA Commissioner: FDLI’s 47th Annual Conference
by Lester M. Crawford, Acting Commissioner of Food and Drugs, Food and Drug Administration (FDA), Rockville, MD.
> The Ongoing Dialogue Between the Food and Drug Administration and the Federal Trade Commission
by Thomas B. Leary, Commissioner, Federal Trade Commission, Washington, D.C. This article is a written version of more informal remarks delivered at the Food and Drug Law Institute’s 47th Annual Conference, Washington, D.C. (Apr. 15, 2004).
> What a Food and Drug Lawyer Should Know About the Medicare Modernization Act
by Alex M. Azar II, General Counsel for the U.S. Department of Health and Human Services, Washington, D.C. These remarks were presented at the Food and Drug Law Institute’s (FDLI’s) 47th Annual Conference, Washington, D.C. (Apr. 15-16, 2004).
> Implementing Food Safety Policies at the U.S. Department of Agriculture :
Overcoming Challenges and Showing Results
by Merle D. Pierson, Deputy Under Secretary for Food Safety with the U.S. Department of Agriculture (USDA), Washington, D.C. This article is based on prepared remarks for his presentation at the Food and Drug Law Institute’s (FDLI’s) 47th Annual Conference, Washington D.C. (Apr. 15-16, 2004).
> Premarket Notifications of New Dietary Ingredients―A Ten-Year Review
by Michael McGuffin, President of the American Herbal Products Association, Silver Spring, MD
Anthony L. Young, Partner in the law firm of Kleinfeld, Kaplan and Becker, LLP, Washington, D.C.
> Express Preemption and Premarket Approval Under the Medical Device Amendments
by Gregory J. Scandaglia, Partner and founding member of the law firm of Scandaglia & Ryan, Chicago, IL.
Therese L. Tully, Associate in the law firm of Scandaglia & Ryan, Chicago, IL.
> State Regulation of Pharmaceutical Clinical Trials
by Jeffrey N. Gibbs, Director in the law firm of Hyman, Phelps & McNamara, P.C., Washington, D.C.
> A Brief History of 180-Day Exclusivity Under the Hatch-Waxman Amendments
to the Federal Food, Drug, and Cosmetic Act
by Erika King Lietzan, Assistant General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, D.C.
> The Errors of Error Testing: Potential Liability Issues for Medication Error Testing of Pharmaceutical Trademarks Under U.S. Law
by James A. Thomas, Partner in the law firm of Nelson Mullins Riley & Scarborough, L.L.P., Raleigh, NC.
> The Food and Drug Administration and Patent Law at a Crossroads: The Listing of Polymorph Patents as a Barrier to Generic Drug Entry
by Devesh Srivastava, Associate in the law firm of Sutherland Asbill & Brennan LLP, Atlanta, GA
> Public Health, Hypocrisy, and Brown-Skinned People
by Christopher T. Nidel, attorney at Baron and Budd, P.C., Dallas, Texas.
Remarks of the Acting FDA Commissioner: FDLI’s 47th Annual Conference
Authors: Lester M. Crawford
Issue: 59 Food and Drug Law Journal 201-208 (2004).
This article, which was delivered as a speech at the Food and Drug Law Institute’s 47th Annual Conference, is one of Dr. Crawford’s first presentations since re-assuming the post of Acting Commissioner of the Food and Drug Administration (FDA). He discusses the agency’s recent achievements in each of the five critical components to FDA’s Strategic Action Plan—a strong FDA, efficient risk management, counterterrorism, patient and consumer safety, and better consumer information—and offers a snapshot of what is in store as FDA moves forward.
| Back to top |
The Ongoing Dialogue Between the Food and Drug Administration and the Federal Trade Commission Author: Thomas B. Leary
Issue: 59 Food and Drug Law Journal 209-216 (2004).
This article, which is a written version of more informal remarks delivered at the Food and Drug Law Institute’s 47th Annual Conference, provides some personal views about the ongoing dialogue between the Food and Drug Administration and the Federal Trade Commission, with particular emphasis on the issues raised by direct-to-consumer advertising of prescription drugs. This dialogue is inevitable because each agency has authority in the area of consumer communications, but they have very different ultimate responsibilities.
| Back to top |
What a Food and Drug Lawyer Should Know About the Medicare Modernization Act
Author: Alex M. Azar II
Issue: 59 Food and Drug Law Journal 217-222 (2004).
Based on a presentation at the Food and Drug Law Institute’s 47th Annual Conference, this article is an overview of some of the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The article discusses some of the problems with existing Medicare that the President and Congress sought to address with the MMA. Then, it describes the transitional prescription drug discount card program and the prescription drug benefit that were created by the MMA. Reviewed next are some of the reforms the MMA made with regard to drug reimbursement under traditional fee-for-service Medicare. Finally, the article touches briefly on the changes the MMA made to Hatch-Waxman.
| Back to top |
Implementing Food Safety Policies at the U.S. Department of Agriculture:
Overcoming Challenges and Showing Results
Author: Merle D. Pierson
Issue: 59 Food and Drug Law Journal 223-228 (2004).
Based on a presentation at the Food and Drug Law Institute’s 47th Annual Conference, this article describes the U.S. Department of Agriculture’s (USDA’s) broad scope of responsibility—to ensure public health through food safety for millions of American consumers. The article provides statistics on USDA’s five-point food safety strategy to further reduce the incidence of foodborne illness: 1) improving the management and effectiveness of regulatory programs; 2) ensuring that policy decisions are based on science; 3) improving coordination of food safety activities with other public health agencies; 4) enhancing public education efforts; and 5) protecting meat, poultry, and egg products against intentional contamination. Also discussed is the single U.S. bovine spongiform encephalopathy (BSE) case, which led to changes and re-evaluations of food safety systems across the country.
| Back to top |
Premarket Notifications of New Dietary Ingredients―A Ten-Year Review
Authors: Michael McGuffin & Anthony L. Young
Issue: 59 Food and Drug Law Journal 229-244 (2004).
In 1994, the newly-enacted Dietary Supplement Health and Education Act (DSHEA) provided a statutory definition of a “new dietary ingredient” and imposed upon such ingredients the requirement that a notification be submitted prior to their use in dietary supplements. The premarket notification system for new dietary ingredients, in its current form and function, generally is working. Implementation of the system, however, has been less than perfect. The lag time between the closing of the file and its submission to the docket is not helpful for firms seeking up-to-date guidance on marketing a new product. Also, industry needs to learn to use this system, to avoid making dietary supplement submissions that are not required (e.g., submitting 75-day notices for ingredients that are not new dietary ingredients) and to avoid the waste of resources when 21 C.F.R. § 190.6 instructions are not followed. Innovative firms will peruse existing files to learn from others’ mistakes and to ascertain what the Food and Drug Administration has come to expect regarding substantive information about new ingredients.
| Back to top |
Express Preemption and Premarket Approval Under the Medical Device Amendments
Author: Gregory J. Scandaglia & Therese L. Tully
Issue: 59 Food and Drug Law Journal 245-264 (2004).
This article explores federal preemption under the Medical Device Amendments (MDA) of 1976 and discusses whether and why conflicting state causes of action should be preempted by the MDA, when the Food and Drug Administration (FDA) approves the device at issue under the premarket approval process. The article first discusses FDA’s regulation of medical devices under the MDA. It then discusses and analyzes the split in the cases that address the MDA’s preemptive effect on state law claims arising out of injuries allegedly caused by an FDA-approved medical device. The article concludes by advocating the preemption of conflicting state law claims against devices approved under the premarket approval process and explaining why these state claims should be preempted under the MDA.
| Back to top |
State Regulation of Pharmaceutical Clinical Trials
Author: Jeffrey N. Gibbs
Issue: 59 Food and Drug Law Journal 265-286 (2004).
In conducting pharmaceutical clinical trials in the United States, sponsors need to comply with myriad regulatory requirements. Clearly, the most important requirements are those established by the Food and Drug Administration (FDA). Good clinical practice regulations concentrate on FDA and related international standards. Nevertheless, there are a large and increasing number of state requirements that apply to pharmaceutical clinical studies. Ironically, while there has been considerable discussion about the harmonization of international standards, within the United States there appears to be increasing divergence among the states. Some states have adopted their own statutes regulating informed consent in clinical trials. States also have promulgated their own laws and regulations governing genetic testing, privacy, and clinical research. Drug companies should give greater consideration to developing mechanisms to ensure compliance with various state requirements, and sponsors need to consider whether multiple states’ laws might apply to their investigations.
| Back to top |
A Brief History of 180-Day Exclusivity Under the Hatch-Waxman Amendments
to the Federal Food, Drug, and Cosmetic Act
Author: Erika King Lietzan
Issue: 59 Food and Drug Law Journal 287-324 (2004).
This article summarizes the history of the 180-day exclusivity provision in the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA). First, it presents the statutory language, as amended in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), and summarizes the law that applies to new abbreviated new drug applications (ANDAs), as well as the law that applies to all other (“old”) ANDAs. Then the article describes the legislative history of the original 1984 provision and traces its judicial and administrative history. Finally the history of the 2003 amendments and its key changes are described. While Congress addressed in 2003 a number of the i nterpretive issues that had arisen since 1984, the new law is intricate and undoubtedly will give rise to new interpretive questions in the future.
| Back to top |
The Errors of Error Testing:
Potential Liability Issues for Medication Error Testing of Pharmaceutical Trademarks Under U.S. Law
Author: James A. Thomas
Issue: 59 Food and Drug Law Journal 325-338 (2004).
Medication error testing is increasingly popular for potential pharmaceutical trademarks. The Food and Drug Administration (FDA) is close to introducing rules regarding such testing as part of a new pharmaceutical product’s approval. Such tests, however, have not yet been verified and are often the origin of “false positive” results (i.e., indications of possible confusion that, in fact, are not likely at all). Pharmaceutical companies, therefore, often must interpret test results and proceed with a mark despite such results. This article explores the potential products liability that may arise from such testing, and considers the impact of FDA guidance in this area.
| Back to top |
The Food and Drug Administration and Patent Law at a Crossroads:
The Listing of Polymorph Patents as a Barrier to Generic Drug Entry
Author: Devesh Srivastava
Issue: 59 Food and Drug Law Journal 339-354 (2004).
Pharmaceutical and therapeutic evaluation of two drug compounds, and a patent infringement analysis of the same two compounds are not the same. Generic drugs may be pharmaceutically and therapeutically equivalent to a brand-name drug without infringing the innovator patents that the drug references. A recent rule change by the Food and Drug Administration (FDA), however, will unnecessarily delay the agency’s approval of generic drug applications. The rationale behind the rule change is an effort to create consistency with pharmaceutical and therapeutic equivalence upon which FDA reviews abbreviated new drug applications (ANDAs). The rule change allows the listing of patents in the Orange Book that do not cover the approved drug and would inappropriately trigger a thirty-month stay upon the filing of a patent infringement suit. It is an inappropriate trigger because the rule change requires the listing of patents claiming structurally-similar drug compounds when those drug compounds are not actually approved by FDA. If it was not the drug approved by FDA, then the controlling statute regarding the listing of patents in the Orange Book (21 U.S.C. § 355(b)(1)) would not be satisfied. If the patent at issue does not claim the approved drug, then no claim of patent infringement reasonably may be asserted. Therefore, the rule change is inconsistent with the controlling statute, and the listing of such patents in the Orange Book would be wrong.
| Back to top |
Public Health, Hypocrisy, and Brown-Skinned People
Author: Christopher T. Nidel
Issue: 59 Food and Drug Law Journal 355-382 (2004).
Advances in science over the last fifteen years have generated new medicines that effectively can be used to treat HIV/AIDS. Despite private and public financial contributions and efforts made to reduce drug prices, these drugs continue to be available to a select few. Generic drug producers offer the same treatments at a fraction of the cost, but often are accused of being in violation of domestic and international patent laws. The mounting recognition of the magnitude of the HIV problem, balanced against the interest in protecting the intellectual property rights of individuals, creates a definite conflict. This tension has been addressed under U.S. laws in cases dealing with compulsory immunizations and forced isolation of those suspected to be infected with tuberculosis. In these cases, the courts found that private rights are subordinate to greater public health interests, and that the sovereign government may use its inherent police power to limit the extent of private rights. More recently, this valuation was echoed in comments that U.S. government officials made when dealing with the pricing and availability of drugs needed to treat a potential anthrax attack; they threatened to disregard manufacturers’ patent rights if the cost and availability requirements of the U.S. government were not met. Acknowledging that U.S. law may recognize an exception based on current public health needs, this article goes a step further to assess the possibility that a sovereign government may exercise its police power to limit the private patent rights of drug manufacturers. A bioethical framework is applied, accounting for the purposes of the patent system as well as its limitations. The article concludes that a sovereign government, when faced with a crisis of HIV proportions, inherently has the power to act on behalf of the public and that intrusion into private rights, namely private intellectual property rights, appears justified within the proposed bioethical framework.
| Back to top |