Seventh Circuit Finds State Consumer Protection Claim Preempted by Food, Drug and Cosmetic Act
10/28/11
On October 17, 2011, the Seventh Circuit Court of Appeals affirmed a district court ruling dismissing a state law consumer … Learn More
Longest Prison Sentence to Date for Violations of the FCPA
10/27/11
On October 25, 2011, the former president and the executive vice president of Terra Telecommunications Corp. (Terra) were sentenced in connection with their convictions at trial for money laundering and violating the Foreign Corrupt Practices Act (FCPA). Learn More
Tax Court rules against corporate taxpayers who relied on advice from in-house professional
10/26/11
On June 7, 2011, Judge Foley in writing for the Tax Court held that corporate taxpayers cannot rely on the … Learn More
Tax Court Finds no “reasonable cause” for income omission where taxpayer provided information to and relied on tax return preparer
10/24/11
In Woodsum v. Commission, 136 T.C. No. 129 (June 13, 2011), Judge Gustafson addressed the taxpayers’ petition for redetermination of … Learn More
Bill Proposes to Change How FDA Reviews Medical Devices
10/24/11
On October 14, 2011, Representative Brian Bilbray introduced a bill before the U.S. House of Representatives, entitled the “Novel Device … Learn More
Par Pharma Brings Suit Against FDA Over Promotional Claims
10/20/11
On October 14, 2011, Par Pharmaceutical, Inc. (Par Pharma) brought suit against the U.S. Food and Drug Administration (FDA) challenging … Learn More
Company Pleads Guilty to Selling Misbranded Drug
10/19/11
On October 14, 2011, Medisca, Inc. pled guilty to introducing a misbranded drug into interstate commerce in violation of the federal Food, Drug and Cosmetic Act (FDCA). The Complaint, which was filed on October 14, alleged that Medisca purchased a drug called “Somatropin” from China and then proceeded to distribute the drug to various pharmacies throughout the United States. Learn More
U.S. Marshals Seize Detained Food under Authority of FSMA
10/19/11
An illustration of FDA’s increased powers, a recent seizure was the first directed by the FDA under the authorization of the Food Safety Modernization Act (FSMA). Specifically, on October 11, 2011, the U.S. Food and Drug Administration (FDA) announced that U.S. Marshals seized food products at the FDA’s request. The food, which was being held at a storage and processing facility in Washington, was originally detained due to an infestation found during a FDA inspection. After having ordered the detention of the food products on September 2, 2011, FDA sought a warrant for the arrest of the products in federal court, ultimately resulting in the seizure. Learn More
FDA and CMS Launch Voluntary Parallel Review for Innovative Products
10/19/11
On October 7, 2011, the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced the official launch of the parallel review program. An effort to increase patient access to a variety of medical devices and drugs, the program is designed to facilitate the development of innovative medical products and reduce the time between FDA approval and CMS national coverage determinations. Learn More
FDA Extends Comment Period for New Dietary Ingredient Draft Guidance
10/19/11
On September 8, 2011, the U.S. Food and Drug Administration (FDA) announced that the comment period for its draft guidance, entitled Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, will be extended until December 2, 2011. The draft guidance, issued on July 5, 2011, consists of more than 120 Q&As aimed at helping industry determine whether a dietary ingredient is a NDI, whether a notification is required, and what information should be included in the notification. Please see our previous report here for more information regarding NDIs. Learn More