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FDA Approves First At-Home HIV Test

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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 collect an oral fluid sample by first swabbing the gums. Thereafter, the sample is placed in a vial where the results will be displayed within 20 to 40 minutes. Of course, like most other at-home tests, the FDA warns that the results of the test are not definitive in nature and that additional testing in a clinical setting should be…
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GlaxoSmithKline to Pay $3 Billion in Settlement with Government

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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 pleading guilty to marketing two of its drugs, Paxil and Wellbutrin, for unapproved uses and for failing to report post-marketing safety issues associated with its diabetes drug Avandia. In addition to the hefty fine, totaling some $3 billion dollars, GlaxoSmithKline will be subject to continued monitoring by the government for the next five (5) years. GSK's( GlaxoSmithKline ) Press Release discussing…
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House Oversight Committee Finds that FDA Actions Cause Drug Shortages

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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 of generic injectable medications. Despite finding a variety of factors responsible for the shortages, including the scarcity of raw materials and increasing demands, the House Oversight Committee concluded that the shortages were largely precipitated by the actions of the U.S. Food and Drug Administration (“FDA”).The full text of the Staff Report may be accessed here. In detailing how the FDA’s actions…
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Marshals Seize Misbranded Drug Products at Maine Facility per FDA’s Request

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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 discovered that the firm was making improper claims in various promotional materials, including the products’ labels and the firm’s website. The Press Release announcing the recent seizure may be accessed here. Global Biotechnologies, Inc., the firm targeted in the seizure, had been cited by the FDA before for the same type of deficiencies. In particular, the FDA issued a Warning…
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FDA Releases Draft Guidance Updating Warnings for Labeling of Albumin, Highlighting Risk of Creutzfeldt Jakob Disease

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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 Variant Creutzfeldt-Jakob Disease by Blood and Blood Products.’ Found here, the Document highlights the recommended changes to labeling in light of current scientific knowledge. Creutzfeldt-Jakob Disease (“CJD”) is a debilitating brain disorder that results in rapidly declining neurological functioning and ultimately death. Related to bovine spongiform encephalitis (“BSE” or “Mad Cow Disease”), variant Creutzfeldt-Jakob Disease (“vCJD”) is extremely rare and thought…
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Study Prompts OIG to Call for Further Training of FDA Medical Device Reviewers

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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 of Health and Human Services (“HHS”), wherein the Office examined the instances of disagreement that occurred during the medical device review process for the years 2008-2010. In conducting the study the OIG surveyed managers and reviewers from the U.S. Food and Drug Administration’s (“FDA’s”) Center for Devices and Radiological Health (“CDRH”) and asked these individuals to identify the scientific disagreements…
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FDA Alerts Consumers of an Array of Dangers Associated with Reumofan Plus Supplement

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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 the Agency the product poses a risk to consumers and those currently taking the product should cease use and contact a health professional immediately. The alert issued by the FDA may be accessed here. The FDA warned of several deficiencies it found with the product. In particular, the FDA noted that the label, which appears solely in Spanish, identifies the…
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U.S. Marshals Seize Products from California Firm upon FDA ’s Repeated Finding of Violations

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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 drug at issue was being marketed without FDA approval and therefore in violation of the Federal Food, Drug and Cosmetic Act (“FFDCA”). In particular, the seizure came as a result of two inspections conducted by the Agency, where the firm was found to be selling the product in violation of a number of FDCA provisions. Crescendo Therapeutics, LLC, the firm…
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FDA Notifies Consumers of Supplement Recall after Discovery of Undeclared Drug Ingredients

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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 after an FDA laboratory analysis uncovered the presence of undeclared Tadalafil in an assortment of the Company’s products. Tadalafil is the active ingredient in Cialis, the popular drug approved by the FDA to treat Erectile Dysfunction (“ED”). Because of the presence of the undeclared pharmaceutical ingredient, the FDA warns that the Company’s products are considered unapproved new drugs under the…
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FDA Expands Use of Device to Detect both Viral and Bacterial Causes of Respiratory Infection

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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 cleared for the simultaneous detection of both viral and bacterial causes of respiratory infection. The device was originally cleared by the FDA in 2011 to detect only viral causes of respiratory infection. Now, with the expanded panel, the device is cleared to concurrently detect 17 viruses and three bacteria. The FDA’s regulation of medical devices follows a three-tier approach. Class…
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