Publications

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 …

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 …

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 …

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 …

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 – …

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 they are confronted …

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, …

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 …

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 …

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

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 …

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 …

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.

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

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 …

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 …

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 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 …

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.

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 …

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 …

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 …

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 …

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 …

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 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, …

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 …

Pharmaceutical data mining may be described, in part, as the business of collecting information relating to prescribers’ (e.g. doctors, dentists, and nurse practitioners) prescribing habits. This information is then sold to other companies that use the information in their business. A specific example of this practice entails pharmaceutical data …

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 …

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 …

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 …