On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) approved the first over-the-counter (“OTC”) at-home test kit used to detect human immunodeficiency virus (“HIV”). According to the FDA’s announcement, the OraQuick In-Home HIV Test allows the user to …
GlaxoSmithKline to Pay $3 Billion in Settlement with Government
On July 2, 2012, GlaxoSmithKline (“GSK”) announced its intention to plead guilty in its ongoing healthcare fraud case in what will result in the largest settlement of its kind in the United States. In particular, the pharmaceutical giant will be …
House Oversight Committee Finds that FDA Actions Cause Drug Shortages
On June 15, 2012, the U.S. House of Representatives Committee on Oversight and Government Reform issued a Staff Report, detailing the problem of drug shortages for key lifesaving drugs. According to the Report, the shortages are largely affecting the availability …
Marshals Seize Misbranded Drug Products at Maine Facility per FDA’s Request
On June 6, 2012, the U.S. Food and Drug Administration (“FDA”) announced the seizure of various drug products from a Portland, Maine facility. According to the FDA, U.S. Marshals seized the drug products upon the Agency’s request after it was …
FDA Releases Draft Guidance Updating Warnings for Labeling of Albumin, Highlighting Risk of Creutzfeldt Jakob Disease
On June 11, 2012, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled Draft Guidance for Industry: Amendment to ‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and …
Study Prompts OIG to Call for Further Training of FDA Medical Device Reviewers
On June 5, 2012, the Office of the Inspector General (“OIG”) published a report entitled, “Executive Summary: Scientific Disagreements Regarding Medical Device Regulatory Decisions.” The Summary, found here, details a study undertaken by the OIG, an office in the Department …
FDA Alerts Consumers of an Array of Dangers Associated with Reumofan Plus Supplement
On June 1, 2012, the U.S. Food and Drug Administration (“FDA”) issued an alert to consumers on the product Reumofan Plus. Purportedly marketed as a dietary supplement, Reumofan Plus is manufactured in Mexico by the company Riger Naturals. According to …
U.S. Marshals Seize Products from California Firm upon FDA ’s Repeated Finding of Violations
On May 22, 2012, the U.S. Food and Drug Administration (“FDA”) announced that U.S. Marshals, acting at the requests of the Agency, had seized certain products deemed to be unapproved new drugs. HybriSil (methylprednisolone acetate 1% in silicone gel), the …
FDA Notifies Consumers of Supplement Recall after Discovery of Undeclared Drug Ingredients
On May 18, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release announcing the voluntary recall of certain dietary supplements marketed as male enhancements. West Coast Nutritionals, Ltd., the firm responsible for the supplements, initiated the recall …
FDA Expands Use of Device to Detect both Viral and Bacterial Causes of Respiratory Infection
On May 15, 2012, the U.S. Food and Drug Administration (“FDA”) announced the clearance of expanded uses for the FilmArray Respiratory Panel, a medical device used to detect causes of respiratory infection. Manufactured by Idaho Technology, Inc., the device is …