Volume 63 Issue 4
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Table of Contents
by
Nathan J. Bailey, Attorney at Greenblum & Bernstein, PLC, Reston, VA
63 Food and Drug Law Journal 735-752 (2008).
In an attempt to save lost profits, the meat industry is increasingly utilizing a particular type of modified atmospheric packaging (MAP) technique, which involves the addition of carbon monoxide (CO) to meat, in order to keep meat a bright and attractive reddish pink color. Carbon monoxide makes treated meat appear fresher than it actually is and can result in a misled consumer being ultimately harmed by masked pathogens. In 2002, however, the Food and Drug Administration (FDA) accepted the use of CO in MAP systems as being “generally recognized as safe” (GRAS), a classification that exempts the use of CO from premarket review and approval by the FDA. This commentary details the history of CO’s current GRAS designation and the current clash between retailer associations and consumer groups regarding the FDA’s acceptance of the meat industry’s use of CO in meats. Secondly, this commentary discusses the legal background of GRAS notifications and the differences between the use of the terms “food additive” and “color additive” in the Federal Food, Drug, and Cosmetic Act. Thirdly, policy and legal concerns regarding the adulteration of foods are discussed. And finally, the commentary offers a proposed solution to the problems caused by the use of CO in MAP and the FDA’s current GRAS notification process.
by
John B. Reiss, Partner in the Business Department, Saul Ewing, LLP, Philadelphia, PA
Jerome R. Aquino, a 2008 Summer Associate with the law firm of Saul Ewing, LLP, Philadelphia, PA
Monique A. Bair, a 2008 Summer Associate with the law firm of Saul Ewing, LLP, Philadelphia, PA
Christopher D. Belen, a 2008 Summer Associate with the law firm of Saul Ewing, LLP, Philadelphia, PA
Patrick M. Hromisin, a 2008 Summer Associate with the law firm of Saul Ewing, LLP, Philadelphia, PA
63 Food and Drug Law Journal 753-798 (2008).
This wide-sweeping survey article deals with how the courts have handled matters in a number of legal arenas affecting manufacturers of pharmaceuticals, medical devices or biotechnology products.
The article covers enforcement actions by FDA and activities involving FTC and SEC. The article pays particular attention to the latest fraud and abuse cases. Manufacturers may be especially interested in the issue of corporate officers being held liable individually, as evidenced in the OxyContin case, which is discussed in this article.
by
Rikin S. Mehta, a Clinical Hospital Pharmacist at Robert Wood Johnson University Hospital, New Brunswick, NJ
63 Food and Drug Law Journal 799-822 (2008).
This article explores the importance issue of “gifting.” Pharmaceutical industry sales representatives often visit physicians’ offices and pharmacies to provide medical information on their particular drug product. Competing pharmaceutical companies and sales reps vie for a physician’s time by proffering gifts, offering lunches or making available other incentives that will win a doctor’s attention. In the community pharmacy setting, sales reps regularly drop off items of daily utility such as pens and pill counting trays stamped with the company’s drug name and imprimatur where the use of those items naively incorporates into a pharmacist’s workflow. The concept of gifting items of value facilitates and encourages association between practitioners and industry sales reps. However, when excessive gifting hampers a physician or pharmacist’s independent judgment in drug therapy selection, regulations must be promulgated in order to curtail undue influence upon prescription writing.
Strategies to Protect Blockbuster Franchises
by
Daniel I. Gorlin, Consultant at the Boston Consulting Group, Chicago, IL
63 Food and Drug Law Journal 823-864 (2008).
At the turn of the 21st century, Schering-Plough and AstraZeneca, two of the world’s largest pharmaceutical companies, both anticipated losing marketing exclusivity on their largest and most profitable drugs. Both companies employed similar, multi-faceted strategies in their attempts to protect and extend these multibillion dollar franchises. Yet, the two companies experienced dramatically different results. Where AstraZeneca’s follow-on product flourished and earned the company billions of dollars, Schering- Plough’s product did not reach even a quarter of its predecessor’s sales, resulting in a major reorganization of the company’s operations and management. Ultimately, the differing results can be attributed to AstraZeneca’s ability to create the requisite pre-conditions for market acceptance of its follow-on product. AstraZeneca conducted head-to-head trials between the original blockbuster and its follow-on; controlled the transition of patients from the predecessor drug to the follow-on by launching the follow-on product while its predecessor still had marketing exclusivity; and secured preferential reimbursement positions on formularies for its follow-on product.
by
Abram S. Barth, General Attorney for the Food and Drug Administration,
Office of the Chief Counsel
63 Food and Drug Law Journal 865-890 (2008).
On November 14, 2007, the Food and Drug Administration (FDA) hosted a public meeting to hear the projected public health value of adding into the current prescription/nonprescription drug duality, a class of drugs that requires a pharmacist's intervention prior to dispensing: behind-the-counter (BTC) drugs. The public meeting, which renewed a debate initiated in 1974 when FDA first rejected the BTC class concept, was divided along professional lines: pharmacist-supporters and physician-opponents. Supporters charged that a BTC class holds the promise of expanding access to relatively safe drugs, whereas opponents contended that a BTC class could harm the public's health by pushing untrained pharmacists to the medical fore of diagnosing and prescribing. This article sets to answer two questions not resolved at the public meeting: can FDA create this BTC class (a legal discussion), and should FDA create this BTC class (a policy discussion).
The legal portion of this article lays out the current regulatory landscape and identifies what legal routes remain open to FDA to implement a BTC class within the confines of the Federal Food, Drug, and Cosmetic Act, FDA's regulations, and case law. The policy portion considers the effects a BTC class would have on healthcare access, quality, and costs. Supported by foreign and domestic experiences, the current practice of pharmacy, and the proven public health value of pharmacists, this article concludes with a recommendation that although FDA may have statutory authority to create a BTC class, policy counsels for administrative-restraint to leave intact America's current drug classification system.
of Follow-On Biologics: Issues and Opportunities
by
Lisa D. DiMartino, Clinical Research Manager at the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC
Lesley H. Curtis, Associate Professor in medicine at the Duke University School of Medicine, Durham, NC
Roger L. Williams, Executive Vice President and Chief Executive Officer of the United States Pharmacopeia, Rockville, MD
Darrell R. Abernethy, Chief Science Officer for the United States Pharmacopeia,
Rockville, MD
Kevin A. Schulman, Professor of medicine and an Associate Director of the Duke Clinical Research Institute at the Duke University School of Medicine, Professor of business administration and the Director of the Health Sector Management Program at the Fuqua School of Business, Duke University, Durham, NC
63 Food and Drug Law Journal 891-900 (2008).
By 2010, it is estimated that $10 billion in biologics will have lost patent protection and that generic versions, or “follow-on” biologics, will begin to emerge. The manufacturing processes required to produce biologics are complex, and safety and efficacy profiles may be specific to the manufacturer. Postmarketing surveillance studies may be required to detect rare safety signals. Medicare claims may provide a useful mechanism for postmarketing surveillance of follow-on biologics. The authors briefly describe the regulation of innovator and follow-on biologics, the need for postmarketing surveillance of follow-on biologics, and how Medicare claims data might be used to monitor postapproval safety.
Validity of the 510(k) Premarket Notification Process
by
James M. Flaherty, Jr., Attorney with Foley Hoag LLP in Boston, MA
63 Food and Drug Law Journal 901-928 (2008).
In September 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Included within this legislation was a provision requiring the Government Accountability Office (GAO) to conduct a study of the 510(k) premarket notification process, which is the premarket regulatory pathway for medium-risk medical devices. The 510(k) process is based on the concept of substantial equivalence, whereby a new device is compared to a legally-marketed device to determine whether the new device is as safe and effective as the marketed device. If the Food and Drug Administration determines that the new device is substantially equivalent to the marketed device, then the new device is “cleared” for commercial distribution.
Some courts, commentators and critics have questioned whether the 510(k) process adequately protects the public health. The 510(k) process, however, provides a reasonable assurance of safety and effectiveness through its substantial equivalence determination. Moreover, the 510(k) process strikes an appropriate balance between protecting public health while also promoting public health by providing access to medium-level risk devices as quickly as possible. Because of the crucial role the 510(k) process plays in the medical device regulatory scheme, the GAO should endorse the 510(k) process in its report to Congress.
by
Ruth K. Miller, Senior Counsel at The United States Pharmacopeial Convention,
Rockville, MD
Carlos Celestino, Counsel at United States Pharmacopeial Convention, Rockville, MD
Gabriel I. Giancaspro, Director for Dietary Supplements in United Stated Pharmacopeial Convention’s Division of Standards Development, Rockville, MD
Roger L. Williams, Executive Vice President and Chief Executive Officer of United States Pharmacopeial Convention, Rockville, MD
63 Food and Drug Law Journal 929-942 (2008).
The Food and Drug Administration’s (FDA’s) current good manufacturing practices (cGMP) regulations represent a substantial advance in ensuring the quality of dietary supplements. Under the rule, each manufacturer must develop quality standards for its dietary supplements. Yet manufacturers may keep those standards private, and the rule does not contemplate industry-wide standards for a particular ingredient or product. Thus, a consumer comparing two different brands of a dietary supplement on a store shelf will not be able to determine whether the two products are similar or how they differ.
The authors examine the role of the United States Pharmacopeial Convention (USPC) in establishing public standards and argue that the widespread use of USPC standards for dietary supplements and dietary ingredients, in conjunction with the cGMPs, could help ensure the quality and consistency of these products while conserving resources both on the part of the FDA and manufacturers. Reliance on USPC standards—public specifications containing tests, procedures, and acceptance criteria—would eliminate the need for repetitive development and review of validation and other data to ensure the identity and quality of a specified dietary supplement. Because the cGMPs and USPC standards differ in certain areas, potential safety gaps may result unless they are used in conjunction. Increased use and recognition of USPC standards through one of several options presented could improve the overall safety net for dietary supplements.
by
Yi-Chen Su, a 2009 LL.M., IP candidate at the George Washington University Law School, Washington, DC
63 Food and Drug Law Journal 943-962 (2008).
The U.S. Supreme Court recently held that FDA’s pre-market approval of medical devices preempts state common-law suits. In addition, the recent actions of the executive branch and the Congress both show signs of disfavoring juries in medical-related disputes. The time is probably ripe for the United States to consider adopting agency adjudication systems to supplant state tort actions. This Article employs the comparison of Factor VIII cases in the United States and Taiwan to demonstrate that an agency adjudication system is not only preferable in a plaintiff’s winning situation, but also favorable in a plaintiff’s losing situation where the plaintiff cannot prove causation as the common law requires.
However, the agency adjudication system adopted by a state must be based on a no-fault basis, so as not to offend the recent Supreme Court’s holding in Riegel v. Medtronic, Inc. Finally, the article suggests that the state Medicaid system may play a role in the agency adjudication system by providing victims with free or affordable long-term medical care. As a result, a large one-time payment is not necessary and the victims would not be further jeopardized by rising health insurance premiums following the injury.