FDA – Page 8 – Shehadeh Giannamore, PLLC

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Court Finds FDA’s Prohibition of Off-Label Promotion Unconstitutional

FDA Enforcement, FDA, Labeling, off-label promotion, off-label use

On December 3, 2012, the U.S. Court of Appeals for the Second Circuit reversed the conviction of a pharmaceutical sales representative, finding that promotion of FDA-approved drugs for unapproved uses, in and of itself, does not constitute a violation of the Federal Food, Drug and Cosmetic Act (“FDCA”). The Defendant-Appellant in the case, Alfred Caronia, appealed from his conviction in which he was found guilty of conspiracy to introduce a misbranded drug into interstate commerce, a violation of the FDCA. In particular, Caronia was charged and thereafter convicted for promoting the drug Xyrem for uses not approved by the U.S.…

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FDA Actions Highlight New Authority under FSMA

FDA FDA, Food, Food Facility Registration, Food Safety Modernization Act, FSMA, Recalls, Salmonella

On November 26, 2012, the U.S. Food and Drug Administration (“FDA”) suspended the food facility registration of Sunland, Inc., a New Mexico-based peanut butter plant. Sunland, Inc. has been in the headlines throughout much of 2012 due to a number of recalls spurred after Salmonella was discovered in the Company’s peanut processing facility. More information about the affected products and the ongoing action against Sunland, Inc. may be accessed here. After several successive recalls and months of investigation into the adequacy of Sunland’s facilities, the FDA ultimately suspended the Company’s Food Facility Registration, thereby prohibiting Sunland from producing and distributing…

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FDA Investigates Illnesses Linked to Energy Drinks and Supplements

FDA Adverse Events, Beverages, Dietary Supplements, Energy Drinks, FDA, Food

On November 16, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the Agency’s ongoing investigation of reported illnesses and deaths linked to energy drinks and energy shot supplements. Found here, the Statement details the FDA’s efforts in this area, including its evaluation of adverse event reports. According to the FDA, it is currently in the process of determining whether there is an actual cause-and-effect relationship between the consumption of energy drinks and energy supplements and these medical problems. Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), manufacturers, packers and distributors of all dietary supplement products…

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Jimmy Dean Initiates Recall for Failure to Declare Allergens

FDA Allergens, FDA, Food, Labeling, Recalls

On November 10, 2012, Jimmy Dean issued a Press Release, explaining how the Company is initiating a voluntary recall of certain of its products due to a labeling error that resulted in undeclared allergens. In particular, the Company is recalling certain lots of its French Toast & Sausage Sandwich breakfast products because the labels of such products fail to declare the presence of soy and egg. According to the Company, no other Jimmy Dean brand products are affected. Under the Food Allergen Labeling and Consumer Protection Act (“FALCPA”), all food labels must declare the presence of major food allergens. Pursuant…

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FDA Warns Company for Marketing Medical Device

FDA 510(k), Disease Claims, FDA, Labeling, Medical Devices, PMA, Warning Letters

On November 5, 2012, the U.S. Food and Drug Administration (“FDA”) announced recent action the Agency has taken against a Tennessee-based company in connection with the Company’s alleged violations of the Federal Food, Drug and Cosmetic Act (“FFDCA”). According to the FDA’s Press Release, found here, The Avalon Effect, Inc. (“the Company”) is in violation of the FFDCA because of several claims made on the Company’s website and other linked websites which contain claims that its light therapy device may be used to cure or treat fungal meningitis, concussions, Lyme disease and other illnesses. In addition, the FDA notes that…

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FDA Targets Online Pharmacies in International Efforts

FDA Drugs, Enforcement, FDA, Medical Devices, Warning Letters

On October 4, 2012, the U.S. Food and Drug Administration (“FDA”) announced that it has taken action as part of an international campaign to protect consumers from illegal online pharmacies. Found here, the FDA’s announcement explains its involvement in the international regulatory efforts referred to as “Operation Pangea V.” The week long efforts mark the fifth annual International Internet Week of Action (“IIWA”), whereby international regulatory and law enforcement authorities engage in cooperative efforts aimed at tracking down and stopping distributors and producers of unapproved and illegal pharmaceutical products and medical devices. In addition to Operation Pangea V, the FDA recently announced…

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FDA Approves MS Drug, Noting Boxed Warnings

FDA Adverse Events, Boxed Warnings, Drugs, FDA, Labeling

On September 12, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of the drug Aubagio (teriflunomide). Manufactured by Sanofi Aventis, Aubagio is a once-a-day tablet for the treatment of relapsing forms of multiple sclerosis (“MS”) in adults. The full announcement of the approval may be accessed here. As noted in the FDA’s announcement, Aubagio contains a Boxed Warning intended to alert prescribers and patients of certain risks, including liver problems and birth defects. Accordingly, prescribers are warned to refrain from prescribing Aubagio to patients who have existing liver problems. In addition, prescribers are required to verify that…

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FDA Warns Dietary Supplement Firms for Marketing Concussion Treatments

FDA Dietary Supplements, Disease Claims, Drugs, Food, Labeling, Structure-Function Claims, Warning Letters

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

FDA Accelerated Approval Program, Drug, Drugs, FDA, Pediatric, post-marketing studies

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

FDA Drugs, FDA, HIV

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…