Expertise in all things FDA
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 …
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 …
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.
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 …
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 …
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 …
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 …
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 …
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” 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 …
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 …
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.
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, …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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.
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, …
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 & …
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 …