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US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News

Executive Summary

This past week in US regulatory, legislative, legal and political news affecting the biopharmaceutical industry included the disclosure by Valeant Pharmaceuticals International Inc. in its long-awaited 10-K of new government investigations into the firm's pricing and business practices and an expression of regret at a Senate hearing by exiting CEO Michael Pearson and board member Bill Ackman about the price hikes of some of the Canadian firm's drugs and a pledge for changes at the embattled company; an agreement by Pfizer Inc. to pay $784.6m to settle a False Claims Act lawsuit in which its subsidiary Wyeth Pharmaceuticals was accused of reporting false and fraudulent prices to the US Medicaid program; a lawsuit filed by the consumer watchdog Pubic Citizen asserting the FDA's practice of blacking out certain information about its advisory committee members in their curricula vitae and keeping it hidden from public view is unlawful; oral arguments at the US Supreme Court in a case involving the Patent Trial and Appeal Board's use of the broadest reasonable interpretation standard to determine the validity of patents under the increasingly popular inter partes review process; and a negative recommendation by an FDA advisory committee for Sarepta Therapeutics Inc.'s Duchenne muscular dystrophy drug eteplirsen, which angered a crowd of patients, family members and advocates at the close of a grueling nearly 12-hour meeting; plus other Washington news.

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US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News
US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News
US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News
US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News
US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News

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