Expertise in all things FDA
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 …
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 …
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.
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 …
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 …
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’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 …
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 …
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 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 …
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 …
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 …
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 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 …
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 …
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 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 …
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 …
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, …
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 …
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 & …
Washington Legal Foundation Vol. 32 No. 17 Additional information available here.
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 …
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, …
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 …
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 …
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 …
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 …
Two new draft guidances could affect how laboratory tests are developed in the future. Additional information available here.
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 …
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, …
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 …
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, …
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 …
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 …
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 …
Additional information available here.
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 …
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. 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 …
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 & …
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 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., …
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.
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 …
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 …
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 …
“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 …
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 …