US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News
This article was originally published in Scrip
Executive Summary
This past week in US regulatory, legislative, legal and political news affecting the biopharmaceutical industry included the unveiling by the US Patent & Trademark Office of new rules, set to be finalized May 1, under which patent owners will have a more level playing field for inter partes reviews, although now the process just got more expensive for everyone; the declaration by one top US health official that the government is caught in a "game of cat and mouse" because industry is reluctant "to put skin in the game" for developing products against the Zika virus until the firms know there's going to be money to support those efforts; the FDA's release of long-awaited guidance for labeling for biosimilars, which regulators said should rely largely on the relevant safety and effectiveness data used by the corresponding US-licensed innovator medicines, with appropriate product-specific modifications; and the disclosure by the Securities and Exchange Commission it had settled charges against Steven Burrill, who was accused of stealing money from a $283m venture capital fund to support his "lavish lifestyle;" plus other Washington news.