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FDA Warns Dietary Supplement Firms for Marketing Concussion Treatments

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On September 6, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to two dietary supplement companies in connection with promoting unapproved products as drugs. According to the FDA, the firms cited by the Agency, PruTect Rx and Trinity Sports Group, Inc., were targeted for the improper marketing of products labeled as dietary supplements. The FDA alleges that despite being labeled as dietary supplements, these products were labeled with a variety of claims to treat concussions and prevent concussion-related disorders. Accordingly, the FDA has found these products to be unapproved new drugs, in violation of the Federal Food,…
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FDA Approves First Drug Specifically Formulated to Treat Pediatric Tumors

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On August 29, 2012, the U.S. Food and Drug Administration (“FDA”) announced the Agency’s approval of a new drug formulated specifically to treat children with a rare type of brain tumor, known as subependymal giant cell astrocytoma (SEGA). Manufactured by Novartis, Afinitor Disperz is a new dosage form of the existing anti-cancer drug Afinitor. While approved by the FDA in November 2010, Afinitor was for use only in patients three years of age and older. With this new approval, Afinitor Disperz is recommended for use by patients ages 1 and older. This approval is significant in that Afinitor Disperz is…
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FDA Approved Combination Pill for HIV Treatment

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On August 27, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of Stribild, a drug intended to treat the HIV-1 infection in adult individuals who have not previously received treatment for the infection. Manufactured by Gilead Sciences, Stribild is a combination pill containing four separate drugs, two previously approved for the treatment of HIV (elvitegravir and cobicistat) and two new drugs (emtricitabine and tenofovir disoproxil fumarate). The FDA approved pill is a significant step in the treatment of HIV in that it illustrates the evolution and simplification of treatment options for the infection, which was formerly treated…
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FDA Publishes Final Guidance Explaining Egg Safety Rule

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On August 20, 2012, the U.S. Food and Drug Administration (“FDA”) announced the availability of the final guidance document entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” Found here, the Guidance details the new requirements for industry under the Egg Safety Rule. The full-text of the Rule, as found in 21 CFR part 118, may be accessed here. According to the FDA, the Guidance explains the requirements of the Egg Safety Rule and in particular, answers the questions asked by industry since the publication of…
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Listeria-Laden Onions Spur Recalls throughout United States

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On July 28, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release notifying consumers of a voluntary recall initiated by GH Foods CA, LLC. The recall covers a variety of products containing certain onions distributed by Gills Onions and shipped to various packagers and retail supermarkets throughout the United States. According to the California-based manufacturer, the recall was initiated because the onions have the potential to be contaminated with listeria monocytogenes. The recall of Gills Onions initially commenced on July 18, 2012 but has since been expanded and prompted several other recalls of its kind. Because the…
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FDA Proposes New Unique Identifier System for Medical Devices

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On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) announced its intention to require most medical devices in the United States to bear a Unique Device Identifier (“UDI”). According to the FDA, this UDI system could potentially improve availability and quality of information in medical device adverse event reporting and in the event of product recalls. Under the text of the Proposed Rule, published in the Federal Register on July 10, 2012, a UDI will include a unique numeric or alphanumeric code identifying the specific device model and a production identifier, containing the current production information for the…
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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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FDA Warns Makers of RockStar Coffee & Energy Products

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On May 23, 2012, the U.S. Food and Drug Administration (“FDA”) issued a Warning Letter to the manufacturers of the widely popular RockStar energy products, Rockstar , Inc. (“the Company”). Found here, the Letter contains various allegations that the Company’s products are adulterated under the Federal Food, Drug and Cosmetic Act (“FFDCA”) and FDA regulations. In particular, the Company’s RockStar Roasted Coffee & Energy products, including Premium Blended Mocha Cream & Coffee, Premium Blended Latte Cream & Coffee, and Light Vanilla flavors, are allegedly adulterated under the FFDCA because of the ingredients used and the way they are marketed. Pursuant…
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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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