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Status Updates - October 2014 #8

..Doctor in the mouse. What if you could input a list of your current symptoms to Google, and quickly be connected with a doctor for a brief consultation? For a limited trial period, Google seems to have set up such a system...more

Status Updates - June 2014 #4

..Are threats made on social media protected free speech, or potentially criminal acts? The U.S. Supreme Court has agreed to examine the constitutionality of a federal law making it a crime to transmit communications...more

New Reprint Guidance Maintains Bipartisan Status Quo

On February 28, 2014, the FDA issued its most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses. With minor textual revisions, this new Guidance essentially restates the safe...more

J&J Will Pay $2.2 Billion and Enter 5-Year CIA to Settle Off-Label and Kickback Charges

This week, the DOJ announced that J&J has agreed to pay over $2.2 billion in civil and criminal fines in one of the nation’s largest ever health care fraud settlements. As part of the resolution, J&J subsidiary Jannsen will...more

D.A.R.E. to Market Off-Label Uses of Prescription Drugs? Make Sure You are in the Second Circuit: United States v. Caronia and the...

Truthful, non-misleading off-label promotion of prescription drugs is not illegal. At least, not in the Second Circuit. This, despite the billions of dollars in civil and criminal penalties assessed against pharmaceutical...more

New Enforcement Guidance from the UK’s Information Commissioner’s Office

(LONDON) Who is on the ICO’s radar these days? August seems to be the month for getting new guidance documents out the door at the United Kingdom’s Information Commissioner’s Office. The UK ICO has just published guidance...more

Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more

Appeals Court Rejects Drug Company Executive’s First Amendment Defense and Upholds Wire Fraud Conviction

A three-judge panel of the U.S. Court of Appeals for the Ninth Circuit, in a recent unpublished opinion, upheld the conviction and sentencing of former InterMune, Inc. executive Scott Harkonen for wire fraud. In 2009, a jury...more

United States v. Caronia: Second Circuit Rules Manufacturers Cannot Be Criminally Prosecuted for Off-Label Promotion of Drugs...

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical manufacturers and their...more

Federal Court Vacates Conviction for Truthful Off-Label Promotion of FDA-Approved Drug

In a highly significant decision that may have far-reaching implications for the U.S. Food and Drug Administration’s (FDA) regulatory approach to off-label drug promotion, the U.S. Court of Appeals for the Second Circuit...more

In ‘Bitter Pill,’ FDA Seizes Domain Names of Firms Selling Illegal Pharmaceuticals

In an aggressive step against businesses selling drugs online, the U.S. Food and Drug Administration, in conjunction with the U.S. Department of Homeland Security, took legal action earlier this month against more than 4,100...more

D.C. Circuit Holds That Former Purdue Pharma Executives Who Pleaded Guilty to Misdemeanor Misbranding May Be Excluded From...

On July 27, 2012, in Friedman et al. v. Sebelius, the United States Court of Appeals for the D.C. Circuit held that the Department of Health & Human Services may exclude from participation in federal health care programs...more

Abbott Labs to Pay $1.6 Billion to Settle Consumer Protection and Misbranding Claims

Abbott Laboratories (Abbott), an Illinois company, will pay over $1.6 billion in penalties to the federal government and several states related to its alleged illegal promotion of the prescription drug Depakote for off-label...more

Criminalizing Knowledge: The Perverse Implications for Off-Label Promotion Prosecutions of the "Intended Use" Regulations

The article examines the "Catch-22" life-science manufacturers are placed in when they know of an off-label use for the products they manufacture. Off-label use is pervasive in the medical field, in fact, it is often...more

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