Hogan Lovells Publications

False Claims Act: A Year in Review 2016

The False Claims Act (FCA) today bears little resemblance to the law President Lincoln signed 154 years ago to stop con artists from selling the U.S. Army gun powder barrels filled with saw ...

Hogan Lovells Publications

OIG releases revised and expanded self-disclosure protocol

On April 17, 2013, the Office of Inspector General of the Department of Health and Human Services (OIG) released a revised self-disclosure protocol (SDP) that significantly overhauls the process for providers and others to voluntarily disclose and resolve instances of potential fraud involving federal health care programs. The revised protocol adds substantial new guidance on assembling the content included in disclosures and the process for resolution of disclosed matters, including new minimum settlement amounts and a shortened period for completing the required internal investigation.

Read more: OIG releases revised and expanded self-disclosure protocol

Hogan Lovells Publications

Free speech mandates vacating off-label promotion conviction, says Second Circuit

In a split decision raising significant questions for ongoing investigations, company practices, and future prosecutions, the United States Court of Appeals for the Second Circuit vacated a pharmaceutical sales representative’s conviction after concluding that his off-label promotion was constitutionally protected speech. The government had prosecuted the sales representative for conspiring to introduce a misbranded drug into interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), and the government’s case to the jury focused on recorded conversations in which the sales representative engaged in speech about unapproved uses of an approved drug (also called off-label promotion). The appeals court held that the FDCA’s misbranding provisions do not criminalize the simple promotion of a drug for off-label use because such a construction of the statute would run afoul of the First Amendment.

Read: "Free speech mandates vacating off-label promotion conviction, says Second Circuit"

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