Publications

Can FDA Seek Restitution or Disgorgement?January 1st, 2003
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 …
Claims for Functional Foods Under the Current Food Regulatory SchemeSeptember 30th, 2002
Claims for Functional Foods Under the Current Food Regulatory Scheme (Nutrition Today, Functional Foods issue, Vol. 37, No. 5, pp. 217-219)
U.S. Food and Drug Law and FDA – A Historical BackgroundJuly 20th, 2002
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”
First Amendment Implications of Labeling and Advertising RestrictionsJune 22nd, 2002
What You Say May Be Used Against YouMay 30th, 2002
How FDA’s New Labeling Rule Could Preempt State LawJanuary 1st, 2002
FDA’s Regulation of Internet Promotion and AdvertisingJuly 1st, 2001
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 …
FDA’s Crackdown on Cholesterol Structure – Function Claims – A Portent of Policies to Come?May 31st, 2001
Criminal Prosecutions Initiated for the FDAApril 23rd, 2001
The Washington Legal Foundation Litigation and Its AftermathFebruary 1st, 2001
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, …
Marketing Dietary Supplement/OTC Drug Combination ProductsOctober 1st, 2000
How to Transfer Ownership of a 510(k) ClearanceApril 1st, 2000
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) …
Sample Promotion Under the New PDMA Final RulesJanuary 30th, 2000
Comments, Pediatric Testing of Prescription Drugs: The Food and Drug Administration’s Carrot and Stick for the Pharmaceutical IndustryJanuary 1st, 2000
Regulation of Labeling and Advertising Claims, in Cosmetic Regulation in a Competitive EnvironmentJanuary 1st, 2000
Regulation of Labeling and Advertising Claims, in Cosmetic Regulation in a Competitive Environment (Norman F. Estrin and James M. Akerson, ed. 2000).
Keep Current with HPM’s FDA Law BlogJanuary 1st, 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 …
It’s the Law: Compliance with FDA’s Financial Disclosure RuleNovember 1st, 1999
A Voluntary Disclosure Programs for FDA – The Time has ComeJanuary 1st, 1999
“It’s Time to Make A Good Agency Better”: The Food and Drug Administration Modernization Act and the First AmendmentJanuary 1st, 1998
Additional information available here.
Displaying Investigational and Unapproved Medical Devices According to FDA PolicyOctober 1st, 1997
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 …
The History, Provisions and Implementation of the Generic Drug Enforcement Act of 1992January 1st, 1994
The Role of the Department of Justice in Enforcement Matters Relating to the Food and Drug AdministrationJanuary 1st, 1991
FDA and Radiological Health: Protecting the Public From Radiation Hazards in Food and Drug LawJanuary 1st, 1991
Richard M. Cooper editor Food and Drug Law Institue Series 1991
Administrative Inspections by the Food and Drug Administration: the Role of the Department of JusticeJuly 1st, 1989
FDA and Radiological Health: Protecting the Public From Radiation Hazards in Seventy-Fifth Anniversary Commemorative Volume of Food and Drug LawJanuary 1st, 1984
Food and Drug Law Institute Series 1984