News & Publications

  • 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, …

  • HPM Announces New Director and AssociateMay 11th, 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 & …

  • 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 …

  • Coordination Between FDA And CMS: Strategic Considerations For Medicare Coverage And Payment, And The Growing Impact Of CMS In The MarketplaceAugust 22nd, 2006

    Coordination Between FDA And CMS: Strategic Considerations For Medicare Coverage And Payment, And The Growing Impact Of CMS In The Marketplace was presented at the FDA Regulatory and Compliance Symposium at Harvard, August 22-25, 2006. Medicare is the largest purchaser of health care in the U.S., …

  • FDA’s Final Compliance Policy Guide for Marketed Unapproved Drugs ─ Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle?August 16th, 2006

    In June 2006, the FDA issued its long-awaited Compliance Policy Guide (“CPG”) concerning the Agency’s enforcement priorities and policies for marketed unapproved drugs. FDA’s final CPG is part of FDA’s ongoing drug safety initiative.

  • Medtronic Reaches Settlement over Allegations of Illegal Physician Payments to Promote Spinal ProductsJuly 18th, 2006

    On July 18, 2006, Medtronic, Inc. reached a settlement agreement with the U.S. Department of Justice pursuant to which Medtronic will pay $40 million to the United States and participating states to settle allegations stemming from two qui tam lawsuits, United States ex rel. [UNDER …

  • CMS Coverage with Evidence Development Policy Highlights Differences Between FDA and CMS Clinical Evidence RequirementsJuly 12th, 2006

    After much delay, the Centers for Medicare & Medicaid Services (CMS) issued its final policy on Coverage with Evidence Development (CED) on July 12, 2006. The policy revises the controversial draft policy, issued on April 7, 2005, in response to public comments that raised …

  • Medicare to Reconsider Clinical Trial PolicyJuly 10th, 2006

    On July 10, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Analysis (NCA) tracking document to reconsider its Clinical Trial Policy (to be renamed Clinical Research Policy), originally issued in 2000. The reconsideration is open for public comment through August …

  • New Law Reins in “Authorized Generics” Despite Generic Industry Court Losses, But Leaves Several AmbiguitiesJune 12th, 2006

    “Authorized generics” have increasingly been the subject of debate as brand-name firms more frequently incorporate them into lifecycle management strategies, often to dilute the effects of generic competition. The recently enacted Deficit Reduction Act of 2005 (DEFRA) may curb the marketing of some authorized generics …

  • Sponsor of Clinical Drug Trial Not Required to Continue Providing Drug to Participants After Termination of the StudyMay 6th, 2006

    The Sixth Circuit in the case of Abney v. Amgen, Inc. has affirmed the district court’s denial of the plaintiffs’ request to order Amgen to continue to provide an investigational drug. The plaintiffs participated in a clinical trial of a drug to treat Parkinson’s …

  • Safeguarding the Food Supply – FDA Given Sanitary Food Transport AuthorityMay 5th, 2006

  • Appeals Court Finds Right to Post-Phase I Investigational New Drugs; Makes Controversial Comments about Off-Label Use and PromotionMay 5th, 2006

    On May 2, 2006, the United States Court of Appeals for the District of Columbia Circuit concluded in a two-to-one ruling that mentally competent, terminally ill adult patients have the right to obtain potentially life-saving investigational new drugs that FDA has determined, based on Phase …

  • Health and Speech Rights at Risk from Attacks on Medical EducationApril 12th, 2006

    Continuing Medical Education (CME) plays a critical role in the healthcare system. Medical school is merely the start of a physician’s education; however, physicians need to remain current in the decades following completion of their formal education. With the rapid growth in medical information, the …

  • Federal Court Holds FDA to 180-day Statutory Deadline for Approving Drug Marketing ApplicationsApril 10th, 2006

    On April 10, 2006, the United States District Court for the District of Columbia issued a memorandum opinion in the case of Sandoz, Inc. v. Leavitt that is useful precedent for companies with drug applications languishing at the FDA. In this case, the court granted …

  • The Drug Enforcement Administration’s Final Rule on Theft and Significant Loss Reporting: We Can See More Clearly NowApril 1st, 2006

    The pharmacist in charge of Kilgoban Pharmacy is conducting a routine inventory. When comparing the actual on-hand quantity of schedule II drugs with a computergenerated printout of the theoretical count, the pharmacist finds that the oxycodone 40 mg. tablet counts do not match. In fact, …

  • Product liability drug case not preempted by FDC ActMarch 3rd, 2006

    On March 3, 2006, Judge Crabb in the Western District of Wisconsin denied the defendants’ motion to dismiss. Plaintiff contends he lost his sense of taste after taking Prilosec. Judge Crabb ruled that plaintiff’s state common law claims are not preempted by FDA regulations. …

  • Medicare CED: Considerations and ImplicationsMarch 1st, 2006

    In light of the rapid pace of development of new medical technology and treatment, the Centers for Medicare & Medicaid Services (CMS) is faced with a significant challenge in developing an efficient process to determine what technology and treatments effectively improve the health outcomes of …