News & Publications

FDA’s Regulation of Combination Products: The Road AheadNovember 1st, 2003
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 …
Close but No Cigar: The WHO Framework Convention on Tobacco Control’s Futile Ban on Tobacco AdvertisingOctober 1st, 2003
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).
Enforcement and Litigation Conference: Actions Against CompetitorsSeptember 23rd, 2003
Avoid FDA Problems: Implementing a Corporate Compliance ProgramJune 5th, 2003
When All Else Fails: Understanding the Medical Devices Dispute Resolution PanelJune 1st, 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 …
HIPAA and Drug Company Interactions with Physicians – Beyond Clinical ResearchMay 30th, 2003
FDA’s Regulation of Analyte-Specific ReagentsFebruary 1st, 2003
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 …
Promoting Devices for Specific Indications Based Upon a General ClearanceFebruary 1st, 2003
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 …
Western States Medical Center: A Watershed Moment for FDA’s Regulation of Commercial SpeechJanuary 31st, 2003
Universal health coverage anchored in the right to healthJanuary 17th, 2003
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 …
Ripe for Revision: Reassessing the Contitutionality of Food and Drug Administration Restriction on Protected SpeechJanuary 1st, 2003
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 …
Medical Device Reporting: A Risk-Management ApproachJanuary 1st, 2003
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 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