Fda Law Blog

This blog covers topics of interest to Food and Drug Administration-regulated companies, fellow food and drug and health-care lawyers and regulatory personnel, as well as people just generally interested in FDA law. The blog provides timely updates on FDA enforcement actions, proposed rules, personnel changes, new and improved policies, along with related issues such as health-care fraud and abuse, drug and device reimbursement, HIPAA, and other topics of interest.

Author: Kurt R. Karst is an associate and Jeffrey N. Wasserstein is a partner at Hyman, Phelps & McNamara in Washington, D.C.

Blawg Related Categories: Administrative Law • Health Law • Tort Law • Product Liability Law • Associate • Partner

Recent Posts from FDA Law Blog

CPSC Posts Draft Guidance Document on CPSIA Testing And Certification Requirements – Silent On Products Subject to the PPPA’s Child-Resistant Packaging Requirements
By Anne Marie Murphy – The Consumer Product Safety Improvement Act of 2008 (“CPSIA”) made significant changes to the laws enforced by the Consumer Product Safety Commission (“CPSC”). CPSIA Section 102 amended the Consumer Product…
Yes, There is a Way to Market a Drug as a Supplement
By Ricardo Carvajal – Several Congressional representatives wrote a letter to FDA asking the agency to “fully implement” a provision of the FDCA that allows marketing as a dietary supplement of an article previously investigated…
GAO Issues Report on Surrogate Endpoint Accelerated Approvals; Calls for Enhanced Oversight
By Kurt R. Karst – A recent report from the Government Accountability Office (“GAO”), titled “FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints,” finds that weaknesses in FDA’s…
Supreme Court to Decide Whether an FDA Warning Letter Starts the Statute of Limitations in a Securities Fraud Case
By Carrie S. Martin – On November 30, 2009, the United States Supreme Court will hear oral argument in Merck & Co. v. Reynolds, No. 08-905, a securities class action. The case concerns the standard…
What is a Tobacco Product “Ingredient”?
By Ricardo Carvajal, David B. Clissold & Jeffrey K. Shapiro – FDA has published a draft guidance for industry on the listing of ingredients in tobacco products that manufacturers and importers are required to submit…
Senate Committee Seeks Improved Access to Controlled Meds for Long-Term Care and Hospice Patients; Drafts Legislation to Address Issue
By John A. Gilbert and Larry K. Houck – Senate Special Committee on Aging Chairman Herb Kohl (D-WI) and Member Sheldon Whitehouse (D-RI) have sent a letter to U. S. Attorney General Eric Holder seeking…
HPM Posts Summary of H.R. 3962 Provisions Directly Affecting Drug and Device Manufacturers
By Alan M. Kirschenbaum & Kurt R. Karst – Last Thursday we reported on the release by the House of H.R. 3962, the health care reform bill that will soon be considered on the House…
FDA’s Letter to P&G over VICKS DayQuil and NyQuil Plus Vitamin C is Back (for now?)
By Ricardo Carvajal – FDA has again posted a warning letter to Procter and Gamble stating that the company’s VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus Vitamin C are unapproved new drugs and…
From Various Quarters, Pleas to Tone Down Food Marketing Claims
By Ricardo Carvajal – We’re used to seeing the Center for Science in the Public Interest ("CSPI") take a stick to food marketers. It seems that CSPI now has plenty of friends. First, Connecticut’s Attorney…
Seventh Circuit Affirms Dismissal of FDA-related Lanham Act Case and Quotes William Blake to Boot
JP Ellison – In March of 2008, we reported on a Wisconsin federal district court opinion that dismissed a plaintiff’s Lanham Act claim against three manufacturers of generic prescription drug products. On October 29, 2008,…