Legal Briefs: Rx Data Mining Law Upheld, Angiomax Patent Extended, Accutane Verdict Vacated
• By The Pink Sheet
First Circuit upholds Maine law on prescribers' privacy: A Maine statute allowing physicians to choose not to make identifying information about their prescribing available for use in marketing is constitutional, the U.S. Court of Appeals for the First Circuit ruled Aug. 4. IMS Health, Verispan and Source Healthcare Analytics filed suit to block the law claiming its restrictions on use of prescribers' identifying data limited free speech and also regulated transactions outside of Maine in violation of the dormant Commerce Clause. In 2008, the First Circuit upheld a similar New Hampshire law that banned the sale of physician prescribing data (1"The Pink Sheet," Nov. 24, 2008). In the current case, IMS v. Mills, the court said the statute regulates conduct not speech and that it "constitutionally reaches plaintiffs' out-of-state transactions as a necessary incident of Maine's strong interest in protecting opted-in Maine prescribers from unwanted solicitations.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.
A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.
Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.