News & Publications

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 …

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 …

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 …

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 …

Additional information available here.

Displaying investigational and unapproved devices at trade shows, in directed mailings, and on the Internet is important to the vitality of the medical device industry. For instance, to attract investment capital, manufacturers need to educate potential investors about the kinds of technology under development. In …

Richard M. Cooper editor Food and Drug Law Institue Series 1991

Food and Drug Law Institute Series 1984