When it comes to off-label promotion, FDA and industry have been engaged in a cat-and-mouse game for years. And in March, Congress got involved, too. The House Committee on Oversight and Government ...

Doctors can and often do prescribe medications for different purposes than what the FDA has approved them for. But drug companies face tight restrictions on communicating with physicians about these ...

In a continuing shift of enforcement strategy, the U.S. Department of Justice (DOJ) has firmly taken control of off-label use allegations against pharmaceutical, biotechnology, and medical device ...

A former pharmaceutical sales representative for Orphan Medical, Alfred Caronia was responsible for promoting the company’s narcolepsy drug Xyrem. A whistleblower accused Caronia and a company speaker ...

In 2008, the United States Supreme Court held in Riegel v. Medtronic, Inc. that a federal statute, the Medical Device Amendments of 1976, barred (or preempted) state tort law claims against ...

The Seventh Circuit affirmed the dismissal of a False Claims Act (FCA) retaliation suit against AbbVie Inc. (formerly Allergan) brought by former sales representative Jeffrey Lewis. In the complaint, ...

While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

For prescription drugs, demonstrated benefits define the parameters of acceptable risks. For example, liver toxicity may be acceptable in a drug approved for cancer, but unacceptable in a drug ...

Merrill Goozner, the author of the author of The $800 Million Pill: The Truth Behind the Cost of New Drugs, questions the assumption that a greater push toward compliance has reduced off-label drug ...

The U.S. FDA inked a Dec. 20, 2022, warning letter to Righteye LLC that handed the company a list of quality system issues in dire need of redress, but the agency was more concerned about off-label ...