Regulatory Roundup: FDA Issues Safety Warning Regarding Zocor; And More.

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ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA Issues Safety Warning Regarding Zocor; And More.

Regulatory Roundup
Jose Castillo of Ft. Lauderdale, Florida, Federico M. Fermin of Miami Beach, and Terri L. DeCubas of Pembroke Pines, Florida, were indicted on Mar. 18, 2010 on charges of mail fraud, distribution of prescription drugs without a license, money laundering, and conspiracy to commit those offenses. In addition, DeCubas was charged with making a false statement to a US Food and Drug Administration agent, according to a press release from the US Attorney’s office in the Southern District of Florida. The FDA Office of Criminal Investigations’s Miami Field Office also was involved in the investigation. The fraud encompassed the diversion of prescription drugs through street purchases. In related news, the US Attorney for the Western District of Missouri, Beth Phillips, announced that a business owner pleaded guilty to conspiring to fraudulently market dietary supplements over the Internet, making claims that the products could prevent, treat, or cure several diseases. FDA’s Office of Criminal Investigations also participated in this investigation.

FDA released a safety announcement on Mar. 19, 2010 regarding the potentially increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication Zocor (simvastatin) 80 mg, compared with the risk to patients taking lower doses of simvastatin and possibly other drugs in the statin class. The agency is reviewing related clinical-trial data and adverse-event reports. Patients and healthcare professionals can obtain more information on the agency’s website.


Every year, FDA’s Center for Drug Evaluation and Research releases an ombudsman report. The document focuses on the role of the ombudsman and the interactions he or she has with constituents during the year. For example, the report notes that in 2009, the ombudsman’s office received 764 communications. The most common topics of communications from industry were the requirement for electronic drug establishment registration, the lengthy response times to citizen and suitability petitions, and import-export issues such as drug-product seizers at the border. The full report is available here.