Publications

In recent years, both industry and consumer groups have grown frustrated with the 510(k) notification process, the most common premarket review process for medical devices. In 2009, in response to these concerns, the Center for Devices and Radiological Health (CDRH) began an internal review of …

Nutritional Outlook – The manufacturer’s resource for dietary supplements & healthy foods and beverages. Additional information available here.

Pharmaceutical and medical device applicants faced with an adverse decision from FDA (e.g., regarding data requirements, study design, or regulatory pathway) may dispute that decision through multiple routes. The appeal processes in both CDER and CDRH offer numerous strategic and procedural advantages that, when used …

One of the key underlying issues facing the development of all drugs, and particularly orphan drugs, is what kind of evidence the Food and Drug Administration (FDA) requires for approval. The Federal Food, Drug, and Cosmetic [FD&C] Act provides that for FDA to grant approval …

On December 27, 2011, the Center for Devices and Radiological Health (CDRH) issued a draft guidance document on its appeals processes. While the guidance document is helpful in explaining the appeals processes, it does not go far enough. Even if the draft guidance is finalized, …

In the December 19, 2011 Federal Register, CMS published a long-awaited proposed regulation to implement the transparency report requirements of the Patient Protection and Affordable Care Act. Hyman, Phelps & McNamara, P.C. has prepared a summary of the proposed rule. The CMS proposal is unusual …

In a new Legal Backgrounder published by the Washington Legal Foundation, Jeffrey N. Gibbs and Karla L. Palmer write that a recent Florida federal district court ruling in United States v. Franck’s Lab, Inc., if upheld on appeal, will have implications that extend broadly to …

On December 2, 2011, Hyman, Phelps, & McNamara filed comments (here and here) to the controversial draft guidance on New Dietary Ingredient (“NDI”) notifications that FDA issued in July 2011. The current draft guidance ignores the balance struck by the Dietary Supplement Health and Education Act …

In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Of Counsel, and former diversion investigator for the Drug Enforcement Administration (“DEA”), Larry K. Houck, explains the scope of DEA pre-registration and cyclic inspections as a step-by-step guide to actions and procedures …

Many federal prosecutors and investigators believe that private counsel hinder the government’s ability to gather evidence in civil and criminal matters. To circumvent the involvement of company counsel in such investigations, government officials have increasingly turned to catching potential witnesses and defendants off-guard. Investigators frequently …

For decades, products labeled for research use only (RUO) have been widely sold and used in the United States, playing a pivotal role in the development of new diagnostic tests. During this period, neither the definition of this class of products nor the marketing restrictions …

This FDLI Update article discusses the recent and highly publicized directed verdict for Lauren Stevens, the former in-house lawyer at GlaxoSmithKline, who was on trial for charges that she, basically, lied to the federal government in response to a subpoena demanding documents. United States District …

At first glance, the draft guidance that the US Food and Drug Administration has issued on when to submit a new 510(k) pre-market notification for a change to an existing device does not appear to be too different from its 1997 predecessor. Both the …

Molecular diagnostics are playing an increasingly important part in the practice of medicine. However, molecular diagnostics have not yet made the clinical impact that many had predicted. Multiple factors affect the uptake and utilization of molecular diagnostics, including government regulation. Current regulatory …

Personalized medicine has provided both great hope and great hype. Even partial realization of the potential of personalized medicine could significantly change medicine by enabling the right patients to get the right medicine at the right time in the right dose. Yet while new diagnostic …

This FDLI Update article examines the increasing legislative efforts by states to require prescriptions for products containing methamphetamine precursors (such as pseudoephedrine and ephedrine), and to list them as Controlled Substances. It suggests that such laws would tend to encroach upon the practice of …

After more than 15 years of related cases in the larger matter of The First Amendment v. Dietary Supplement Health Claims, FDA mostly won one. And its winning card? Knowing that the courts will not, and cannot, independently assess whether the scientific evidence provided to …

Research use only (RUO) products are ubiquitous in the life science industry. They are widely sold, prominently displayed at major conferences and routinely used by laboratories. Yet, as common as RUOs are, their regulatory status is not well understood or defined. That is not surprising because …

It is an oft-cited feature of the food and drug enforcement landscape that the Federal Food, Drug and Cosmetic Act (FDCA) does not authorize a private cause of action. Increasingly, however, we see suits brought by private citizens under the Federal False Claims Act(FCA) to …

Ever wonder what happens to the thousands of medical device reports that are filed every month with FDA? Are they being put to good use? In October 2009, the HHS Office of Inspector General(OIG) issued a report titled, “Adverse Event Reporting for Medical Devices. This report …

Food and Drug Law Institute Monograph, Vol. 2., No. 3 Additional information available here.

It is obviously unlawful to discriminate because of race, religion and numerous other criteria. However, one factor generally thought not to be in the “prohibited factors” category is the location of a place of business. Should one business be held to a high degree of scrutiny …

For over 50 years, U.S. food manufacturers and consumers have benefited from a provision of law that enables manufacturers to market a food ingredient without prior government approval – provided that the use of the ingredient is “generally recognized as safe” (GRAS). The right of …

Although FDA appears reluctant to take an aggressive stance with respect to substantiation of health-related claims for foods, FTC has forged ahead with a number of investigations of allegedly false or misleading advertising that have resulted in restrictive settlements – and the plaintiffs’ bar has …

In criminal prosecutions of corporate executives, ignorance of the law and the facts is often no defense. FDA’s application of the Park Doctrine has taken different forms in the decades since its inception. In the 1960’s through 1980’s, FDA frequently prosecuted company officials without any …

Recent developments in the European Union’s regulation on health claims used in food labeling could have the effect of suppressing publication of scientific research on the health benefits of food substances. Given that scientific research and collaboration is an international phenomenon, the negative effect …

In a January 2010 report on off-label promotion and Medicare fraud, television reporter Dan Rather asked Lewis Morris, the Chief Counsel of the Department of Health and Human Service’s Office of Inspector General (OIG): “The executives of these big pharmaceutical companies are never putting on …

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 …