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News & Publications

  • Uncertainty Persists with RUO Products – FDA May Be Considering More Restrictive Approach with Research Use Only AssaysApril 1st, 2011

    Research use only (RUO) products are ubiquitous in the life science industry. They are widely sold, prominently displayed at major conferences and routinely used by laboratories. Yet, as common as RUOs are, their regulatory status is not well understood or defined. That is not surprising because …

  • Drug Regulation DVDs AvailableMarch 22nd, 2011

    HPM and Virginia Tech are pleased to announce the availability of the first two DVDs of the VERSUS series that is being sponsored by the University. They provide an overview of the processes a prescription drug must follow to be approved by the United States …

  • HPM Calls On FDA to Post on the Internet All Court Filings Regarding Enforcement ActionsMarch 11th, 2011

    On January 18, 2011, the President issued a significant Order entitled a “Memorandum for the Heads of Executive Departments and Agencies.” The Memorandum directs “agencies with broad regulatory compliance and administrative enforcement responsibilities” to, within 120 days, “develop plans to make public information concerning …

  • D.I.Y. Enforcement: Relators, the False Claims Act and the FDCAFebruary 1st, 2011

    It is an oft-cited feature of the food and drug enforcement landscape that the Federal Food, Drug and Cosmetic Act (FDCA) does not authorize a private cause of action. Increasingly, however, we see suits brought by private citizens under the Federal False Claims Act(FCA) to …

  • What Happens to Medical Device Reports Once They Reach FDA?January 3rd, 2011

    Ever wonder what happens to the thousands of medical device reports that are filed every month with FDA? Are they being put to good use? In October 2009, the HHS Office of Inspector General(OIG) issued a report titled, “Adverse Event Reporting for Medical Devices. This report …

  • Can We Say That? A Practical Guide to Substantiating Claims for Food and Consumer Health ProductsJanuary 1st, 2011

    Food and Drug Law Institute Monograph, Vol. 2., No. 3 Additional information available here.

  • Must FDA Treat Similarly-Situated Competitors the Same Way?December 28th, 2010

    It is obviously unlawful to discriminate because of race, religion and numerous other criteria. However, one factor generally thought not to be in the “prohibited factors” category is the location of a place of business. Should one business be held to a high degree of scrutiny …

  • On FDA And Food Ingredient Safety: Is The “Gras” Henhouse At Risk?December 3rd, 2010

    For over 50 years, U.S. food manufacturers and consumers have benefited from a provision of law that enables manufacturers to market a food ingredient without prior government approval – provided that the use of the ingredient is “generally recognized as safe” (GRAS). The right of …

  • Firm Announces New Director and Of CounselNovember 15th, 2010

    Hyman, Phelps & McNamara, P.C. is very pleased to announce that Ricardo Carvajal has been named Director of the firm, and that Dara Katcher Levy has been named Of Counsel. Mr. Carvajal’s practice focuses on providing FDA and FTC regulatory counseling and litigation support …

  • The Cost of Inadequate SubstantiationNovember 5th, 2010

    Although FDA appears reluctant to take an aggressive stance with respect to substantiation of health-related claims for foods, FTC has forged ahead with a number of investigations of allegedly false or misleading advertising that have resulted in restrictive settlements – and the plaintiffs’ bar has …

  • The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park DoctrineOctober 8th, 2010

    In criminal prosecutions of corporate executives, ignorance of the law and the facts is often no defense. FDA’s application of the Park Doctrine has taken different forms in the decades since its inception. In the 1960’s through 1980’s, FDA frequently prosecuted company officials …

  • Publish and Perish: A Disturbing Trend in the European Union’s Regulation of Nutrition Health Claims Made on FoodsOctober 1st, 2010

    Recent developments in the European Union’s regulation on health claims used in food labeling could have the effect of suppressing publication of scientific research on the health benefits of food substances. Given that scientific research and collaboration is an international phenomenon, the negative effect …

  • New Use of Old Tools: Career-Ending OIG Exclusion and FDA DebarmentOctober 1st, 2010

    In a January 2010 report on off-label promotion and Medicare fraud, television reporter Dan Rather asked Lewis Morris, the Chief Counsel of the Department of Health and Human Service’s Office of Inspector General (OIG): “The executives of these big pharmaceutical companies are never putting on …

  • U.S. News & World Report Ranks HPM as Top Tier FDA Law FirmSeptember 20th, 2010

    Hyman, Phelps & McNamara, P.C. is proud to announce that the inaugural “Best Law Firms” survey by U.S. News & World Report has ranked HP&M as a “Tier 1” law firm in the area of FDA Law. Only six firms made it to the …

  • Regulating Laboratory-Developed TestsSeptember 15th, 2010

    The U.S. diagnostic market has long been divided into two major regulatory branches. In vitro diagnostic (IVD) kits that are sold by manufacturers to laboratories are regulated by the FDA. Tests developed by a laboratory and offered as a diagnostic service by that laboratory are …

  • Using Social Media in FDA-Regulated Industries: The Essential GuideSeptember 13th, 2010

    Jeff Wasserstein has written a chapter in this book. The Regulation of Social Media: Whither FDA? This chapter provides a foundational understanding of FDA’s regulation of social media and Web 2.0 and offers a practical approach to marketing in this environment. The first section briefly introduces …

  • 15th Anniversary Essay: Regulation Then and NowAugust 30th, 2010

    In the fifteen years since the founding of IVD Technology, the IVD industry-and its regulation by FDAhave both changed. The diagnostic capabilities of IVDs have improved dramatically during that period. Some of the advances, such as high-speed, lower-cost genomic sequencing, seemed like the stuff of …

  • Advertising and Promotion: FDA Is Not the Only Cop on the BeatAugust 18th, 2010

    Companies involved in advertising and promotion of foods, dietary supplements, cosmetics, over-the-counter (OTC) drugs, and devices understand that the United States Food and Drug Administration (FDA) is active these days in enforcing the Federal Food, Drug, and Cosmetic Act (FDCA). However, companies must also be …

  • The Problem of Regulatory UncertaintyJuly 19th, 2010

    IVD manufacturers are accustomed to risk. Taking risks is part of their business. Companies develop plans to identify and mitigate risks, from product development to finished product manufacturing. While risks cannot be eliminated, generally they can be recognized and managed. One category of risks-regulatory risks – …

  • Whistleblowers: Treat Them With Kid GlovesJuly 15th, 2010

    In the May/June 2010 edition of FDLI Update, HPM Director John R. Fleder published his latest article on enforcement matters. This article is entitled “Whistleblowers: Treat Them With Kid Gloves”. [link to article]. The article addresses various issues that companies face when …

  • Regulatory Pathways for Clearance or Approval of IVDsMay 24th, 2010

    Jeff Gibbs has authored a chapter in FDLI’s In Vitro Diagnostics: The Complete Regulatory Guide book. His chapter focuses on IVDs that are developed and submitted to FDA for commercialization and addresses some of the key aspects of marketing IVDs, including the regulatory review processes, …

  • The Lanham Act: Another Vehicle to Enforce the Food, Drug, and Cosmetic Act?April 1st, 2010

    Increasingly, plaintiffs have brought Lanham Act claims which arguably asserted private enforcement of the FDCA. In those cases, defendants commonly argue that a plaintiff cannot use the Lanham Act to enforce the FDCA. In the absence of any bright-line rule from the Supreme Court or …

  • Oversight of Research Use Only ProductsMarch 1st, 2010

    The FDA actively regulates medical devices intended for diagnostic use. Diagnostic kits intended for diagnostic use face the full panoply of FDA regulation. In sharp contrast, research use only (RUO) products are essentially unregulated. In fact, although RUO products are often discussed as though they …

  • Court Empowers Qui Tam Defendants To Sue Third Parties For IndemnificationFebruary 26th, 2010

    The Washington Legal Foundation has published a Legal Opinion Letter authored by Jeffrey N. Wasserstein and Nisha P. Shah. Additional information available here.

  • Article, In the Name of Graduate Medical Education: What Mount Sinai Medical Center’s FICA Tax Victory Means for Today’s Teaching HospitalsFebruary 1st, 2010

    After a multi-year battle in federal district and appellate courts, a nonprofit teaching hospital in south Florida was able to walk through a door that the Eighth Circuit and a district court in Minnesota first opened in the cases of Minnesota v. Apfel and United …

  • But My Lawyer Told Me It Was OkayJanuary 29th, 2010

    For heavily-regulated companies, such as those regulated by the Food and Drug Administration, it is common for companies to seek advice from in-house and outside counsel regarding whether proposed conduct would violate the law. It has become increasingly popular for federal prosecutors to target the …

  • In Vitro Diagnostic Tests for Cancer: Regulation of Laboratory Developed TestsJanuary 5th, 2010

    Many new diagnostic tests, including protein-based ones, enter the market as a laboratory developed test. This article briefly describes regulation of these laboratory developed tests. Additional information available here.

  • Retailers on the Radar of FDA Under the Family Smoking Prevention and Tobacco Control ActDecember 28th, 2009

    The article in a recent issue of the Food and Drug Law Institute Update magazine focuses on the Tobacco Act’s impact on retailers.

  • Trends in FDA’s Use of Class-Wide REMSDecember 23rd, 2009

    As FDA becomes more comfortable with the authority provided to it by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), the frequency of Risk Evaluation and Mitigation Strategies (“REMS”) being applied to an entire class of drugs is increasing. The most notable example …

  • The Family Smoking Prevention and Tobacco Control Act: An OverviewDecember 15th, 2009

    This FDLI article summarizes the new Family Smoking Prevention and Tobacco Control Act’s major provisions and highlights some of the legal issues that implementation of the law is likely to raise. Early indications suggest that FDA will move expeditiously to implement the FSPTCA. FDA has …

  • Contracting with the Dietary Supplement cGMPs in MindSeptember 30th, 2009

    Dietary supplement cGMP regulations apply to all companies that manufacture, pack, label, hold, or distribute dietary supplements but not to suppliers of dietary ingredients, non-dietary ingredients, or other components. The regulations also apply to suppliers of bulk dietary ingredients that only need to be …

  • The Park Criminal Liability Doctrine: Is it Dead or is it Awakening?September 25th, 2009

    The so-called Park doctrine allows the government to seek a misdemeanor conviction against company officials for alleged violations of the Federal Food, Drug, and Cosmetic Act (FDCA) – even if a corporate official was unaware of the violation – if the official was in a …

  • 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 …

  • 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, …

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