In their White-Collar Crime column, Elkan Abramowitz and Jonathan Sack write: While off-label prescribing is lawful and sometimes ethically necessary for treatment, the FDA and DOJ have treated ...

The US Food and Drug Administration (FDA) held a 2-day public hearing this week to solicit input about the marketing and use of medications and medical devices for off-label use. It is fairly common ...

Pharmaceutical companies are in the hot seat for allegedly pushing drugs for uses not approved by the government, a growing practice that has triggered a congressional investigation, litigation and ...

But there was also a downside for the government in pursuing the Caronia appeal — especially because the Supreme Court made it clear in a 2010 case called Sorrell v. IMS Health, opens new tab that ...

*Refers to the latest 2 years of stltoday.com stories. Cancel anytime. A new class of pain relievers called Cox II inhibitors burst onto the U.S. market in the 1990s and quickly became blockbuster ...

Curbing False Claims Act Liability for Off-Label Promotion. As class actions have become harder to certify following Wal-Mart v. Dukes and Comcast v. Behrend, the plaintiffs’ bar has increasingly ...