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 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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FTC May Have Won Battle with POM Wonderful but Industry Appears to Have Won the War

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On May 21, 2012, the Federal Trade Commission (“FTC”) announced that it has prevailed in its claim against POM Wonderful LLC (“The Company”) pursuant to a recent ruling by Chief Administrative Law Judge (“ALJ”), D. Michael Chappell. In an Order dated May 17, 2012, Judge Chappell directed the juice giant to refrain from making statements that POM Wonderful 100% Pomegranate Juice and POMx supplements can prevent or treat heart disease, erectile dysfunction and prostate cancer unless the Company has “competent and reliable scientific evidence” to substantiate these claims. Although the FTC is largely heralding the ALJ’s order as a victory,…
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FDA Warns Companies Marketing Supplements Containing DMAA

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On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to several dietary supplement manufacturers in connection with their alleged improper marketing of supplements containing dimethylamylamine (“DMAA”). DMAA, also referred to as geranium extract, is an ingredient found in many dietary supplements and is frequently marketed as a natural stimulant. As discussed in the FDA’s announcement, the Agency considers the marketing of products containing DMAA improper because the ingredient has not been proven to be safe for consumers. Accordingly, these products are considered adulterated under the Federal Food, Drug and Cosmetic Act (“FFDCA”). Under the FDA’s…
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FDA Enters into Consent Decree with Seafood Processor over Alleged Manufacturing Deficiencies

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On April 11, 2012, the U.S. Food and Drug Administration (“FDA”) announced that, with the aid of the Department of Justice, it has entered into a consent decree with a California seafood processor. The consent decree precludes the company from engaging in any manufacture or distribution of fish and fish products until it has remedied certain hazardous conditions in its facilities. Yamaya USA, Inc., the company at issue, was alleged to have been preparing its fish and fish products in facilities contaminated with the pathogen Listeria monocytogenes. For more information about this bacteria, please see our previous report here. In…
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FDA Enters Into Consent Decree of Permanent Injunction with Cheese Producer Due to Listeria Contamination

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On April 9, 2012, the U.S. Food and Drug Administration (“FDA”) announced it has entered into a consent decree with a Washington State cheese producer. The company, Del Bueno, which processes and distributes cheeses, and its owner Jesus Rodriguez, agreed to the terms of a consent decree recently entered by U.S. District Judge, Lonny Suko, in the Eastern District of Washington. As part of the consent decree, Del Bueno cannot sell or otherwise distribute any food products unless and until it first proves that its goods are safe for human consumption. To this end, Del Bueno must develop a control program…
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