More Stringent Safe Harbor Requirements: The Right Prescription?


Privacy issues raise questions for pharmaceutical companies and the future of cross-border data sharing under the U.S. Department of Commerce’s Safe Harbor program. Rolled out in 2000 between the United States and European Union, the program helps U.S. companies satisfy E.U. data protection laws when receiving personal data from the E.U. Participating companies self-certify that they follow a core set of privacy principles. These principles include the duty to notify users regarding the purpose for which their information is collected and the obligation to provide individuals with an opportunity to opt-out of disclosures to third-parties or uses other than those for which the data was originally collected. Companies also represent that they will secure the personal data. Of the nearly 5,000 U.S. companies that have certified that they abide by the Safe Harbor framework, 238 identify themselves as part of the drugs or pharmaceutical industry.
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The Plaintiff Bar’s Latest Attack on Generic Drug Manufacturers: How a New FDA Rule Could Dismantle Recent Legal Victories


Over the past few years, generic drug manufacturers have achieved significant legal victories in the United States, including Supreme Court rulings that state law “failure to warn” and design defect claims against these manufacturers are preempted by federal law. The plaintiffs’ bar, however, has proven to be unflagging in its determination to find a way to impose liability on generic manufacturers, which account for 86% of prescriptions written and 29% of total drug sales in the United States. In this effort, plaintiffs’ attorneys have apparently found a receptive and powerful ear in the Food and Drug Administration (FDA), who, in November 2013, after meeting with the American Association of Justice, a lobbying organization for the plaintiffs’ bar, issued a Notice of Proposed Rulemaking that would effectively deprive generic manufacturers’ preemption defense by allowing generic manufacturers to independently update their products labels. A final version of the proposed rule is expected before the end of the year. Such a move would short-circuit now established legal principles, and expose generic manufactures to numerous lawsuits. The end result could be a monumental increase in the cost of generic prescriptions. In addition, the change may lead to a decrease in the availability of generic drugs that manufacturers perceive as having an elevated risk of litigation.
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FDA Tries to Get Ahead of New Era of Cyber-Terrorism


There is no question that cyber attacks are on the rise, and the likelihood of serious targeted attacks via medical devices is increasing as well. An annual survey conducted by PricewaterhouseCoopers of more than 9,700 security, IT, and business executives found that the total number of overall security incidents detected by respondents climbed to 42.8 million this year, an increase of 48% over 2013. That is the equivalent of 117,339 incoming attacks per day. In light of the serious threats cyber attacks may pose to patient safety, as well as patient information, industry stakeholders have begun to come together to address these threats and improve medical device cybersecurity.
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