Data Protection in the Pharmaceutical Industry: Concerns and Considerations

Leslie Restaino, General Counsel, Validus Pharmaceuticals, USA

Data protection is an important aspect of the pharmaceutical industry throughout all stages of a product lifecycle – from innovation to exit. In the early stages of product development, manufacturers seek to secure trial data to provide a competitive edge; security issues arising during licensing and collaborative activities in the later stages of product development; after development and approval, patients seek to protect their privacy surrounding use of a drug. This latter issue has seen a large amount of recent press. In Sorrell v. IMS Healthcare, Inc., the U.S. Supreme Court struck down a Vermont law involving the purchase of doctor prescribing records from data mining companies to reveal prescribing histories. These prescribing histories were used by pharmaceutical companies to develop targeted marketing strategies. Vermont’s Prescription Confidentiality Law of 2007 required doctors’ consent for such practices. Data mining companies and pharmaceutical manufacturers protested the law, and the Supreme Court in Sorrell ruled that the law in question was an unconstitutional violation of the First Amendment.

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USA Data Protection Pharmaceutical November 2011 Vol. 5, No. 17, Autumn 2011

Leslie Restaino

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Leslie Gladstone Restaino, Esq. has a broad range of experience with the legal and regulatory issues involved in the pharmaceutical/biotechnology, and medical device industries and their complex product, device and services offerings. Leslie has particular expertise in the areas of business/corporate law, pharmaceutical, medical device, and healthcare law, FDA regulatory matters, complex licensing and strategic alliances, commercial contracts, pharmaceutical operations and commercialization, and patents and intellectual property. She is currently the General Counsel of Validus Pharmaceuticals LLC, a specialty pharmaceutical company focusing in the psychiatry and neurology markets. Leslie may be reached by email at lrestaino@validuspharma.com.

Validus Pharmaceuticals

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Validus Pharmaceuticals LLC is focused on acquiring, reformulating and marketing prescription products relevant to the psychiatry and neurology markets. Validus seeks to acquire mature products that have well defined and accepted clinical utility relevant to today’s practice of medicine.

USA Data Protection Pharmaceutical November 2011 Vol. 5, No. 17, Autumn 2011
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