US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News
This article was originally published in Scrip
This past week in US regulatory, legislative, legal and political news affecting the biopharmaceutical industry included the unveiling of a new White House "moon shot" effort to fight cancer, which top officials emphasized is not related to another collaboration using a similar name; the granting of a petition by the Supreme Court to decide whether the Patent Trial and Appeal Board is using the proper standard; US regulators decision to reject the first drug to treat Duchenne muscular dystrophy and their negative review on a competitor's experimental medicine; and the easy pass by the Senate Health panel to confirm Robert Califf as commissioner of the FDA, although the nomination may be held up before the full chamber can vote on the candidate due to one lawmaker's unhappiness over the lack of information about how genetically engineered salmon – often referred to as "Frankenfish" – will be labeled in the US.
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Hillary Clinton's plan to rein in high prices of older medicines, which includes creating a federal panel that has authority to impose fines, may grab headlines, but some analysts think it's unlikely to get very far in a divided Washington.