Month: November 2016

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Our Broken System: Modifying the U.S. Pharmaceutical Regulatory Scheme to Decrease Surging Prescription Drug Prices

By Dan Gutt

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The pharmaceutical industry’s societal purpose is to improve the health of the citizenry. However, the industry is beginning to fail that purpose by producing expensive prescription drugs, which are becoming inaccessible to the average person. Pharmaceutical prices began to spike in 2014, and there is no evidence that this trend will abate in the future. The causes of this phenomenon stem from several factors: expensive patented drugs, a reduction in the supply of generic drugs, and the pharmaceutical industries large marketing and sales expenditures. In summation, this is a complex problem that cannot be solved by a single solution, nor can it be solved by cost covering measures. Instead, innovative solutions that target the root causes of spiking pharmaceutical prices need to be applied. Examples of these solutions include governmental bulk-buying power, longer patent terms, referencing pricing for patented drugs, and improved FDA … Read the rest

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When to Disclose Data Breaches under Federal Securities Laws

By Steven Wittenberg

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Hacking and cybercrime are on the rise.[1] From 2013 to 2015, twenty major data breaches were reported at Fortune 100 companies.[2] Publicly traded companies who have securities disclosure obligations should be aware of their duties under the federal securities laws when it comes to data breaches and hacks.[3]

In 2011, the SEC Division of Corporation Finance issued guidelines for cyber incidents.[4] The SEC stated, “[A] number of disclosure requirements may impose an obligation on registrants to disclose such [cyber] risks and incidents,” although there are no explicit requirements referring to data breaches.

While major data breaches may be material to reasonable investors of public companies, there is no duty to promptly disclose the occurrence of cyber incidents unless there have been selective disclosures, previous misstatements or circumstances making the omission of the hack misleading.[5] The federal securities laws … Read the rest