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News & Publications

  • Efforts to Combat Prescription Drug Abuse Should Not Limit Access to Compounded Pain MedicineSeptember 18th, 2009

    John Gilbert has authored an article titled “Efforts to Combat Prescription Drug Abuse Should Not Limit Access to Compounded Pain Medicine” in the September/October 2009 issue of the International Journal of Pharmaceutical Compounding. Additional information available here.

  • The Custom Device Exemption: What Is It And Does It Ever Apply?September 8th, 2009

    Congress carefully defined the term “custom devices” in 1976, but questions about the meaning of that term have persisted ever since. A recent court case provided an opportunity to clarify the scope of the custom device exemption, for a device that qualifies as a custom …

  • Vindicated on Appeal – It Does HappenJuly 21st, 2009

    John R. Fleder has written an article in the July/August 2009 edition of Update Magazine, which is published by the Food and Drug Law Institute. The article discusses a recent ruling by a federal appeals court in Chicago. That decision vacated and reversed a felony …

  • Banked-Specimen Retrospective StudiesJune 15th, 2009

    Many marketing applications for in vitro diagnostics (IVDs) need to be supported by clinical data. This is especially likely for new analytes or new intended uses. In some instances, the only means to gather the requisite data is by conducting a prospective study. Sometimes, only …

  • Search Warrants – What Happens When the FDA Storm ArrivesMay 30th, 2009

    The thought of federal agents storming the offices of an FDA-regulated company may seem far-fetched to some, but it is becoming a common reality. FDA, in coordination with other federal agencies, is more aggressively using criminal search warrants to collect evidence, catching unsuspecting companies by …

  • Seeing Red Over “Green” – The Fight Over “Organic”, “Natural”, and “Sustainable”May 20th, 2009

    Published in Business Law Today (a publication of the American Bar Association’s Section of Business Law), this article provides an overview of federal regulation of “green” labeling claims such as “organic”, “natural”, and “sustainable”. The use of these valuable marketing claims is governed by …

  • Dermatologic TherapyMay 9th, 2009

    Dermatologists have at their disposal a wide range of products to recommend or prescribe to their patients, all of which are regulated in some way by the Food and Drug Administration (FDA). However, the degree to which FDA has confirmed the safety and efficacy of …

  • The Curious Case of the Prosecution of Lawyer Paul KelloggApril 1st, 2009

    The indictment, trial, conviction and sentencing of Paul Kellogg, the former in-house counsel for Berkeley Nutraceuticals, could be the plot of a movie. Even after the trial and sentencing, whether Kellogg is cast as a criminal mastermind or unwitting dupe remains an open question. Regardless, …

  • Hyman, Phelps & McNamara Issues Analysis Discussing the Implications of the Supreme Court’s Wyeth v. Levine DecisionMarch 16th, 2009

    In Wyeth, the Court ruled that, based on the facts of that case, the Federal Food, Drug, and Cosmetic Act does not preempt state law. Although the immediate effect was to let stand the state law tort judgment against Wyeth, the effects of the …

  • Making the Most of Pre-IDE MeetingsMarch 1st, 2009

    In order to sell diagnostic devices in the U.S., in vitro diagnostic (IVD) manufacturers need to get marketing authorization from FDA. That raises an obvious question: How does a company know what data to submit and which regulatory pathway to use? One way is to ask …

  • Application of Health Care Fraud and Abuse Laws to Pharmaceutical MarketingJanuary 31st, 2009

    Hyman, Phelps & McNamara P.C. has posted an updated version of its outline entitled “Application of Health Care Fraud and Abuse Laws to Pharmaceutical Marketing”. This 89-page outline, authored by Alan Kirschenbaum and Jeff Wasserstein, provides a comprehensive overview of how the federal health care …

  • Imported Products – FDA Is Not Fooling AroundJanuary 27th, 2009

    In light of recent public health scares over imported products, FDA is stepping up its enforcement actions through the creation of import alerts and increased scrutiny over individual shipments of FDA-regulated products. This article examines FDA’s recent activities and emerging issues.

  • FDA’S Implementation of FDAAA’S Food-Related Provisions: A Work in ProgressJanuary 26th, 2009

    This article, published in FDLI Update, provides an analysis of changes in the Federal Food, Drug, and Cosmetic Act (“FDCA”) brought about by the FDA Amendments Act of 2007 (“FDAAA”) that significantly affect the food industry. Title X of the FDAAA requires FDA and industry …

  • Taking control of the IVD submission processJanuary 21st, 2009

    IVD companies face many challenges as they seek to commercialize new tests in the United States, such as issues relating to intellectual property, reimbursement, competition, manufacturing, and pricing. There is also another major hurdle: FDA. Sometimes manufacturers need to make multiple efforts to clear this …

  • Adroit Crafting of “Intended Use” Critical – Regulatory Fate of a New IVD May Well Depend on a Few Dozen WordsNovember 15th, 2008

    In vitro diagnostic (IVD) devices are comprehensively regulated by the FDA. The FDA, however, does not regulate just the physical materials and software comprising an IVD. From a regulatory perspective, a key component of the IVD is an intangible attribute -the product’s intended use. It …

  • A Bad Fit: Qui Tam Actions and Off-Label Use AllegationsNovember 14th, 2008

    Over the past decade, there has been a rise in the number of whistleblower lawsuits filed under the federal False Claims Act in the health care arena. Companies which have allegedly marketed an approved drug product for a use that FDA has not approved have …

  • Surprise!…That Food Is Now a DrugOctober 1st, 2008

    Section 912 of the FDA Amendments Act of 2007 added section 301(ll) to the Federal Food, Drug, and Cosmetic Act (FDC Act), which prohibits the addition to food of an approved drug, a licensed biological product, or a drug or biological product for which substantial …

  • What is Natural?September 25th, 2008

    The question of when it is appropriate to use the term “natural” in food labeling and advertising is of intense interest to the food industry. This webcast for IFT members featured panelists from government and industry. The panelists explored FDA and USDA policies, …

  • Personalized Medicine – Panacea or Pipedream?September 18th, 2008

    “Personalized medicine” has been the subject of rhetorical extremes. On the one hand, there have been claims that personalized medicine is on the verge of revolutionizing healthcare, making it possible to tailor individual therapies to meet the specific needs of each patient. On the other …

  • Cosmetics Product Enforcement – Not an OxymoronSeptember 17th, 2008

    Cosmetic producers beware. Despite some who say that no one cares whether cosmetic products meet regulatory requirements, you may be the subject of an enforcement action. While the Food and Drug Administration (FDA) undoubtedly takes fewer enforcement actions against cosmetic companies and products than it …

  • Lessons Learned from the AbTox RulingSeptember 14th, 2008

    Jeff Gibbs and Susan Matthees recently published an article in MD&DI (Medical Device & Diagnostic Industry). The article provides an overview of the ruling against two AbTox executives in a case that could have significant implications for the medical device industry. Additional information available here.

  • Dietary Supplement GMPs: Legal PerspectivesSeptember 1st, 2008

    FDA has begun implementing its final rule on GMP’s for dietary supplements. Delivered at the American Society for Quality’s 19th West Coast Conference, this presentation explored the final rule’s principal requirements, and addressed compliance strategies with respect to handling of consumer complaints, FDA inspections, …

  • Food Allergens: Legal RequirementsSeptember 1st, 2008

    Labeling errors that involve a food allergen can lead to a Class I recall. Delivered at the American Society for Quality’s 19th West Coast Conference, this presentation explored allergen labeling requirements, the use of advisory labeling, and the interplay between dietary supplement GMP requirements …

  • Checking the Box Can Get You in the Hot SeatAugust 1st, 2008

    Some companies and their executives believe that when the government asks for a certification, the executives should simply make the government happy and sign the document. A recent criminal prosecution demonstrates that a false certification can get both the company and the executive signing that …

  • Regulatory Pathways for Molecular Dx – Detailing the Various Options Available and What Each RequiresAugust 1st, 2008

    Companies focusing on IVDs are regularly confronted with the need to make critical strategic decisions regarding how they commercialize their test. The novelty of the technology and its intended use are just some of the factors that govern what kind of application a firm can …

  • PhRMA Releases Revised “Code on Interactions with Healthcare Professionals” More Restrictive than July 2002 Version; HPM Issues Summary MemorandumJuly 10th, 2008

    On June 10, 2008, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) announced the release of a newly revised version of the “Code on Interactions with Healthcare Professionals,” which is a voluntary code focusing on the industrys interactions with healthcare professionals as they relate to …

  • Cosmetics Labeling and Process for Assigning INCI NamesJuly 10th, 2008

    Errors in determining cosmetic ingredient nomenclature can bring unwanted scrutiny from regulators and from competitors. In a reprise of a webinar delivered to members of the Personal Care Products Council in July, this presentation delivered at the Council’s Science Week delved into ingredient labeling …

  • Primer on Regulation of Diagnostic Assays – Essential Points that Pharmaceutical Companies Need to Know Right NowJuly 1st, 2008

    Historically, pharmaceutical and diagnostic companies in the U.S. have inhabited parallel regulatory universes. Although both sets of firms are overseen by the FDA and are subject to some identical provisions, they have been regulated independently. For the pharma industry, regulatory requirements that apply to in …

  • FDA Nutrition Labeling RequirementsJuly 1st, 2008

    FDA’s nutrition labeling requirements are extensive and detailed, yet they afford some flexibility. Delivered at the IFT 2008 Short Course on Food Labeling and Implications for Foods Marketed in the U.S., this presentation gave an overview of those requirements, with examples of the many …

  • Voluntary Labeling ClaimsJuly 1st, 2008

    FDA’s nutrition labeling requirements are extensive and detailed, yet they afford some flexibility. Delivered at the IFT 2008 Short Course on Food Labeling and Implications for Foods Marketed in the U.S., this presentation gave an overview of those requirements, with examples of the many …

  • Preemption of State Law Tort Suits against Medical Device and Drug ManufacturersJune 30th, 2008

    This question has been the subject of much litigation since the early 1990s. The U.S. Supreme Court has issued a string of decisions in this area, with one case pending. But the preemption waters are likely to remain roiled for some time to …

  • FDA’s Regulatory Extensions: An Overburdened Agency Assigns Itself New ResponsibilitiesJune 13th, 2008

    The Food and Drug Administration (FDA) has been given far-reaching responsibilities by Congress. FDA regulates a vast array of products, including foods, drugs, devices, animal drugs, biologicals, and radiationemitting products. The value of FDA-regulated products is estimated at around $1.5 trillion annually. The sheer scope …

  • The Pathway to Market for Your Medical Device: A Primer on Obtaining Information from FDAMay 28th, 2008

    A recent article in Food and Drug Law Institute’s “Update” magazine provides an overview of ways to obtain advance information from FDA on regulatory issues concerning medical device clearance. The article provides a helpful overview of the options available for approaching FDA as well …

  • FDA Moves Against Marketed Unapproved Human DrugsMay 28th, 2008

    A recent article in Food and Drug Law Institute’s “Update” magazine discusses recent FDA actions against companies marketing unapproved drugs. According to the article, the FDA began an enforcement initiative with respect to such drug products in June 2006 to “ensure that all drugs marketed …

  • The Battle Over rbST Labeling Comes to a Draw. Next Up, Animal ClonesMay 1st, 2008

    This article explains FDA’s approach to the use of labeling claims that address the use of recombinant bovine somatotropin (rbST) in dairy cattle (e.g., “rbST-free”), and explores the controversy over attempts to regulate such claims under state law.

  • FDA’s latest ASR guidance document creates more confusion and raises legal issuesApril 21st, 2008

    In September 2006, FDA issued a draft document, “Guidance for Industry and FDA Staff-Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.” Even though FDA issued the final guidance document one year later, its release has not ended the controversy over how ASRs should be …

  • FDAAA § 912 – A Fundamental Shift in the Dividing Line Between Foods and DrugsApril 16th, 2008

    This FDLI Insighter article examines the potential of § 912 not only to reduce the historic flexibility by which an article may be deemed a food or a drug, but more importantly to deter innovation in the research and development of new food ingredients. Additional information …

  • Courts Rule that Confronting FDA Has CostsApril 1st, 2008

    An article in the March/April edition of the FDLI Update discusses a recent court ruling showing the potential perils faced by a company and its officers who aggressively defend their position.

  • As Nanotech Goes to Market, What Lessons Can We Draw From Biotech?April 1st, 2008

    Delivered at the NanoBioNexus Conference in San Diego, California, this presentation explored the similarities and differences between FDA’s regulatory approach to biotechnology and its approach to nanotechnology. It also discussed the adequacy of FDA’s existing statutory authorities and the emerging interest in regulation of nanotechnology …

  • Nutrition Labeling – A Look at FDA’s Proposed RequirementsFebruary 13th, 2008

    On Nov. 2, 2007, the Food and Drug Administration (FDA) published an Advance Notice of Proposed Rulemaking (ANPR) to revise nutrition labeling requirements for foods and dietary supplements. FDA requested public comments on which nutrients should be listed in Nutrition Facts and Supplement Facts labels, what …

  • FDA Given New Enforcement Authority Under FDAAAFebruary 5th, 2008

    The latest FDLI Update article by Hyman, Phelps & McNamara, P.C., discusses the enforcement provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA). While the enforcement provisions of the new law have frequently been ignored in public discussions about the law, they …

  • FDA Regulation of Nanotechnology: What Are the Rules of the Road?February 1st, 2008

    FDA’s Nanotechnology Taskforce Report, issued in July 2007, identified numerous data gaps that the agency needs to fill, and recommended the issuance of guidance to clarify FDA’s regulatory approach to products derived through nanotechnology. This panel of senior FDA officials provided an update on …

  • Court case determines specimen ownershipJanuary 18th, 2008

    The use of banked specimens by diagnostic and pharmaceutical companies is increasing. As described in a recent article by Anne Marie Murphy and Jeffrey Gibbs describing recent federal litigation, the ability of companies to use these materials can hinge on the informed consent. Additional information …

  • Clinical Trial Participation Unaffected by Disclosure of Investigator’s Financial StakeDecember 21st, 2007

    The willingness to participate in a clinical investigation may not be affected by learning of the investigator’s financial stake, concludes a new study conducted by Gregory A. Guagnano, Ph.D., Associate Professor of Sociology and Anthropology at George Mason University and Jeffrey N. Gibbs of Hyman, …

  • The Pursuit of Civil Money Penalties – An Important Weapon in FDA’s Enforcement ArsenalDecember 4th, 2007

    The Food and Drug Administration (FDA) has a variety of weapons in its enforcement arsenal, including seizures, injunctions, criminal prosecutions, and civil money penalties. On July 6, 2007, FDA reminded regulated industry that it still uses the latter, civil money penalties, when Administrative Law Judge …

  • FDA’s Regulatory Scheme for Human TissueDecember 1st, 2007

    In recent years, industry has accelerated the development of novel cellular and tissue-based products that provide increasingly useful therapies for a wide range of medical conditions. The Food and Drug Administration (FDA) calls these products “human cells, tissues, and cellular or tissue-based products” (HCT/Ps). This …

  • Food, Dietary Supplements, and CosmeticsDecember 1st, 2007

    This presentation provided a detailed overview of FDA’s regulation of foods (including dietary supplements) and cosmetics as part of FDLI’s Fundamentals of Food and Drug Law and Regulation Workshop: Understanding How and Why FDA Regulates the Industries. The topics covered included food safety and …

  • FDA Amendments Act – HPM Issues Detailed Summary and AnalysisOctober 17th, 2007

    Hyman, Phelps & McNamara, P.C. issued a detailed summary and analysis of the FDA Amendments Act (“FDAAA”), which President Bush signed into law on September 27, 2007. FDAAA amends both the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. In addition …

  • The OxyContin Case – Something for EveryoneSeptember 25th, 2007

    The sellers of OxyContin recently agreed to settle government allegations of improper marketing, by entering into one of the largest monetary settlements ever entered into against a pharmaceutical company and its executives. Although the case dealt with controlled substances, it has broad implications for any …

  • CMS Final Rule on the Drug Rebate ProgramAugust 9th, 2007

    On July 17, 2007, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule with comment period to implement the Medicaid Drug Rebate Program. With certain notable exceptions, which are discussed in the referenced memorandum, the final rule is largely consistent with the …

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