Publications

Medical device companies spend considerable time and resources conducting clinical studies to demonstrate the “reasonable assurance of safety and effectiveness” that is needed to gain approval from the Food and Drug Administration (FDA) of a premarket approval application (PMA). But when FDA’s Center for Devices and …

Medical research studies with human subjects are essential to develop lifesaving drugs and medical devices. The medical community needs volunteers—both healthy individuals and those with the disease or condition being investigated—for such studies. The subject’s in- formed consent is key to ensuring that participation is …

In recent years, the Food and Drug Administration (FDA) has embarked on a campaign to add restitution and disgorgement – remedies aimed at correcting past conduct – to FDA’s enforcement armamentarium, notwithstanding the absence of any statutory authority to do so. FDA entered into several high-profile …

The Food and Drug Administration (FDA) is close to finalizing its program for the regulation of human cells, tissues, and cellular or tissue-based products (HCT/Ps). On May 25, 2005, the donor eligibility and current good tissue practice (CGTP) final rules take effect, putting into place …

To review the pharmacology, safety, and efficacy of the prokinetic agents metoclopramide and erythromycin in children.

In the last five years, FDA has entered into a number of high-profile settlements with companies that have agreed to disgorge (forfeit) profits from their sales of products that FDA believed violated the FDC Act. These actions followed a ruling by the Sixth Circuit that …

The Food and Drug Administration (“FDA”) has, in recent years, embarked on a campaign to add restitution and disgorgement – remedies aimed at correcting past conduct – to its enforcement armamentarium. Several high-profile court settlements with large drug and medical device manufacturers seemed to indicate …

Legally, medical device companies may promote their devices with claims of superiority over competing products-or over previous versions of the company’s own products. However, FDA scrutinizes such claims carefully. The agency views comparisons with suspicion, believing that they are potentially misleading and seldom complete. Over …

New Price Disclosure Law: In June 2004, Vermont enacted a drug price disclosure law which requires pharmaceutical companies doing business in Vermont to disclose the Average Wholesale Price (AWP) as reported to a nationally recognized drug pricing file, such as First DataBank, for the …

The Food and Drug Administration (FDA) applies different regulatory requirements to products depending upon whether they are medical devices, drugs or biologics. The agency has established different centers to handle these different types of products: for drugs, the Center for Drug Evaluation and Research (CDER); for …

Christine P. Bump, Comment, Close but No Cigar: The WHO Framework Convention on Tobacco Control’s Futile Ban on Tobacco Advertising, 17 Emory Int’l Rev. 1251 (2003).

Nearly five years ago, Congress directed FDA to set up an advisory panel to help resolve scientific disputes between the agency and industry. The result was the Medical Devices Dispute Resolution Panel. Operating under FDA’s Medical Devices Advisory Committee, the panel helps resolve product-specific scientific …

One of the most confusing areas of FDA regulation surrounds the requirements governing analyte-specific reagents (ASRs). ASRs are raw materials and components used to develop laboratory assays. This article will provide a brief background on FDA’s regulation of ASRs, summarizing the key ASR requirements and …

Many medical devices receive 510(k) clearance from FDA for general indications but are labeled and promoted for more specific indications. Frequently, FDA asserts that such specific uses are not covered by the original clearance and require separate 510(k) clearance or even premarket application (PMA) approval. For …

European Commissioner for Develop-ment Andris Piebalgs recently pointed out the need for “updated and modernised [Millennium Development Goals], pro-viding decent living standards for all – a set of minimum floors below which no one should fall”.1 He added that “these ‘MDGs plus’ would provide the …

In the past few years, the FDA has obtained some very large settlements from companies under the novel legal theories of “restitution” and “disgorgement.” Although the Federal Food, Drug, and Cosmetic Act doesn’t explicitly provide for restitution or disgorgement, the FDA has argued that courts …

Filing medical device reports (MDRs) is undesirable and presents a certain amount of risk to the manufacturer. Fortunately, this risk can be ameliorated by approaching event reporting mindfully and carefully. Most importantly, device makers must not underestimate the risk involved in choosing not to file.

Claims for Functional Foods Under the Current Food Regulatory Scheme (Nutrition Today, Functional Foods issue, Vol. 37, No. 5, pp. 217-219)

Chapter in A Practical Guide to Food and Drug Law and Regulation, Second Edition: “U.S. Food and Drug Law and FDA – A Historical Background”

When internet use accelerated in the late 1990s, some observers predicted that the new technology would add an impossible burden to FDA’s regulation of promotion and advertising. The World Wide Web made possible nearly instantaneous global transmission of information about medical products. It appeared that …

The lawsuit brought by the Washington Legal Foundation (WLF) against the Food and Drug Administration began in 1994 and recently was put to rest, at least temporarily. Amazingly, despite six years of fierce legal combat, two decisions by a district court, an act of Congress, …

Many medical devices require 510(k) clearance or premarket application (PMA) approval from FDA prior to commercial distribution. A firm that is purchasing or licensing medical device technology already on the market needs to make certain that the deal also includes a valid transfer of the 510(k) …

Regulation of Labeling and Advertising Claims, in Cosmetic Regulation in a Competitive Environment (Norman F. Estrin and James M. Akerson, ed. 2000).

Hyman, Phelps & McNamara, P.C. maintains the FDA Law Blog. It covers topics of interest to FDA-regulated companies, fellow food and drug and healthcare lawyers and regulatory personnel, as well as people just generally interested in FDA law. First and foremost, the blog brings you …