Publications

  • 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 …

  • BioShield II: A Step in the Right Direction?July 26th, 2007

    The Department of Health and Human Services (“DHHS”) is convening a four day stakeholders workshop in Washington, D.C. beginning on July 31, 2007 to enable representatives from government, industry, and academia to discuss the government’s evolving plans to develop and procure medical countermeasures to respond …

  • FDA Issues Second Draft Version of IVDMIA GuidanceJuly 25th, 2007

    FDA has released a new draft guidance for In Vitro Diagnostic Multivariate Index Assays (“IVDMIAs”). The first version, which was released on September 7, 2006, attracted many critical comments. The new draft seeks to address some (but not all) of those concerns. Creating …

  • Diet and Weight-Loss Ads Are Fat Targets for FTC ActionJuly 19th, 2007

    Before you do, be sure to become familiar with the Federal Trade Commission’s (FTC’s) regulation of the advertising of such products. The FTC has stepped up its enforcement activity against weight-loss and diet products, and you can expect that trend to continue as companies market …

  • Who Decides Your Fate in FDA Enforcement Matters?May 31st, 2007

    John Fleder has written an FDLI Update article that sets forth the first ever published outline of the agencies and offices that get involved in decisions to commence FDA enforcement actions, such as FDA Warning Letters, seizures, injunctions (consent decrees), and criminal prosecutions. Mr. Fleder, …

  • Jeff Gibbs Cited as FDA Law Authority by Federal Appeals CourtMay 10th, 2007

    On May 7, 2007, the United States Court of Appeals for the Fourth Circuit decided the case of Pharmacists Mutual Insurance Company v. G. David Scyster, No. 06-1334. The case relates to a lawsuit where the plaintiff asserted that it had no liability for injuries …

  • HPM Announces New Director and AssociateMay 3rd, 2007

    Hyman, Phelps & McNamara, P.C. is very pleased to announce that Jeffrey K. Shapiro has joined the firm as a director and Carrie S. Martin has joined the firm as an associate. Prior to joining the firm, Mr. Shapiro was a partner at Hogan & …

  • The Drug User Fee Catch-22May 1st, 2007

    Washington Legal Foundation Vol. 32 No. 17 Additional information available here.

  • NOTE: The R.F.I.D. ACT OF 2006 and E-Pedigrees: Tackling the Problem of Counterfeit Drugs in the United States Wholesale IndustryApril 19th, 2007

    The U.S. Food and Drug Administration (FDA) regulates the drug distribution system within the country and is responsible for protecting public health by promoting access to safe and effective medicines. En-suring safety of the drug supply is clearly important in achieving this goal, but drug …

  • CMS Issues Draft of Revised Clinical Trial Policy, Renamed Clinical Research PolicyApril 11th, 2007

    On April 10, 2007, CMS issued a draft of its revised Clinical Trial Policy, renamed Clinical Research Policy. The draft policy was issued after CMS’s consideration of public comments on the agency’s July 10, 2006 coverage tracking sheet announcing the reconsideration of the September 19, …

  • Crossing the Line: Kickbacks Come Under Increased Government ScrutinyApril 6th, 2007

    During the past several years, government enforcement authorities have focused an increasing amount of attention on the marketing activities of medical device companies. This increased scrutiny has taken the form of investigations through subpoenas and intervention in qui tam lawsuits (lawsuits initiated by a third …

  • CMS Proposes Expanded Use of Part D Data – Will it Stay Confidential?April 3rd, 2007

    On October 18, 2006, the Center for Medicare & Medicaid Services (CMS) issued a proposed rule expanding the collection and permitted uses of Part D data. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) permits, and in some cases requires, CMS …

  • Are Food and Drug Lawyers ‘Real’ Lawyers?April 1st, 2007

    A recent California case raised the question of whether, within the context of the attorney-client privilege, regulatory advice provided by food and drug attorneys qualifies as “legal” (protected) advice or “business” (generally not protected) advice. This California court ruling demonstrates that regulatory advice that food …

  • Questions over FDA’s Authority to Regulate Laboratory Developed TestsMarch 26th, 2007

      Hyman, Phelps & McNamara, P.C. (HPM) submitted a citizen petition to FDA in 1992 asserting that the agency did not have the authority to regulate assays developed by clinical reference laboratories strictly for in-house use (laboratory developed tests). FDA responded to the petition nearly six …

  • ASRs and IVDMIAs: FDA’s New Draft GuidancesMarch 15th, 2007

    Two new draft guidances could affect how laboratory tests are developed in the future. Additional information available here.

  • Abigail Alliance v. von EschenbachMarch 2nd, 2007

    On March 1, 2007, the D.C. Circuit Court of Appeals heard an oral argument in Abigail Alliance v. von Eschenbach. Previously, a divided court of appeals had ruled that where there are no other FDA-approved treatment options, a terminally ill patient’s access to investigational …

  • Medicare Coverage with Evidence Development and Potential Impact on Your Clinical Trial PolicyJanuary 30th, 2007

    On July 12, 2006, Medicare finalized its Coverage with Evidence Development policy, which introduces two new concepts: Coverage with Appropriateness Determination and Coverage with Study Participation. Medicare’s Coverage with Study Participation will be of particular interest to clinical trial sponsors. Under Coverage with Study Participation, …

  • Corporate Compliance Officer – Gatekeeper or JailbirdJanuary 24th, 2007

    Most companies long ago acknowledged the government’s and the courts’ expectation that corporations should institute corporate compliance programs as an important tool to ensure their compliance with all applicable federal and state laws and regulations. An essential element of such programs is the retention of …

  • Winning Legal Strategies for Food & Drug CompaniesJanuary 10th, 2007

    John Gilbert has authored a chapter on regulation of controlled substances in a new book published by Aspatore Books called Winning Legal Strategies for Food & Drug Companies: A Detailed Look at Regulations, Compliance, and Other Major Legal Issues. The book is an authoritative, …

  • Justice Department Alters Its Policies for Prosecuting Business OrganizationsDecember 27th, 2006

    In 2003 and 2005 the U.S. Department of Justice issued policy statements outlining how and when it will criminally prosecute business organizations such as corporations. These statements, which were called the “Thompson Memorandum” and the “McCallum Memorandum” (the names of the two high-ranking DOJ …

  • Falling Short – Final Guidance on Coverage With Evidence DevelopmentDecember 20th, 2006

    The Centers for Medicare & Medicaid Services (CMS) has issued final guidance on Medicare coverage determinations conditioned on Coverage with Evidence Development (CED) that improves on the draft guidance but may require further revision. The final guidance issued on July 12, 2006 responds to …

  • FDA Announces Proposed Regulations to Overhaul and Expand the Availability of Experimental Drugs and to Clarify Permissible Charges to PatientsDecember 12th, 2006

    Yesterday, FDA announced that two proposed rules will be published in the Federal Register on December 14, 2006, that (if implemented) will “make experimental drugs more widely and easily available to seriously ill patients with no other treatment options and [will] clarify the circumstances and …

  • State of the Union: Drug-Device CombinationsNovember 15th, 2006

    Additional information available here.

  • FDA Enforcement of the Food Allergen Labeling LawOctober 23rd, 2006

    The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) took effect January 2006, requiring any food that is labeled to include a declaration of the major food allergens present in the product. Although the law seems very straightforward identify the major allergens in …

  • Pharmaceutical Law R&D 101: Legal Issues During Research and DevelopmentOctober 4th, 2006

    Developing a new drug or biological product is challenging and costly. Even minor missteps can significantly delay a product coming to market. Major missteps can add legal costs to the already mounting research and development costs that are required to prepare a new drug application …

  • Rep. Waxman and Sens. Schumer and Clinton Introduce Biogenerics BillOctober 3rd, 2006

    Rep. Henry Waxman (D-CA), Sen. Charles Schumer (D-NY), and Sen. Hillary Rodham Clinton (D-NY) introduced the “Access to Life-Saving Medicines Act” last Friday. If enacted, the legislation would establish an abbreviated application approval pathway for biological products – so-called “generic biologics,” “follow-on …

  • Application Of Health Care Fraud And Abuse Laws To Pharmaceutical MarketingSeptember 21st, 2006

  • Getting CMS Reimbursement for Medical Technology ProductsSeptember 7th, 2006

    Getting CMS Reimbursement for Medical Products was presented at the FDLI/Clinical Device Group E-conference, September 7, 2006. FDA approved or cleared products are eligible for Medicare coverage and payment. However, many manufacturers have discovered that the Medicare coverage process, administered by the Centers for Medicare & …

  • CMS Proposed Changes to ASP Calculation MethodologyAugust 30th, 2006

    On August 22, 2006, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register a proposed rule entitled “Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2007 and Other Changes to Payment Under Part B.” Although …