On December 3, 2012, the United States Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia (“Caronia”), who had been tried and convicted of participating in an unlawful ...

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 ...

The pharmaceutical industry has recently felt empowered and emboldened by recent litigation that would seemingly allow companies to distribute, proactively, information about unapproved uses, i.e., ...

Medtech executives charged in two high-profile criminal cases are making the argument that FDA is squelching their free speech. Qmed Staff At the same time that the U.S. Justice Department is ...

The FDA has "finalized" guidelines allowing drug companies to promote drugs for unapproved ("off-label") uses. The guidelines will allow companies to distribute peer-reviewed scientific literature ...

The omission of criminal charges for off-label promotion of Serostim is surprising, because the government's earlier plea with Pfizer sent a strong signal that it would criminally charge companies ...

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 ...

While off-label use is sometimes necessary, it should be undertaken with care and caution due to the uncontrolled experiment to which a patient is being subjected. Valuable off-label uses should be ...