Tag: label
UPDATE: Second Circuit Rejects Government’s Off-Label Enforcement Approach
UPDATE TO EARLIER POST:
On Wednesday, January 23, Food and Drug Administration officials said the government will not appeal the decision in the United States v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012). The FDA decided against asking the court to rehear the case, and will not appeal to the Supreme Court. The FDA stated that it “does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug & Cosmetic Act.”
Read Jesse Witten’s recent post on this case here.
Second Circuit Rejects Government’s Off-Label Enforcement Approach
Last week’s decision in the off-label promotion case, United States v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012), is an important blow to the Government’s off-label promotion efforts. In a 2–1 decision, the Court squarely rejected the simplistic theory that the Food, Drug and Cosmetic Act (“FDCA”) imposes a blanket prohibition against off-label promotion by pharmaceutical and device manufacturers, but it does leave open the door to future prosecutions that rely in part on off-label promotion.
In Caronia, the Department of Justice obtained the conviction of Alfred Caronia, a pharmaceutical sales representative, for conspiracy to introduce a misbranded drug into interstate commerce. The FDA prohibits the introduction into interstate commerce of a misbranded drug (or device). 31 U.S.C. § 331(a). A drug is misbranded if, among other ways, its labeling fails to contain “adequate directions for use,” 21 U.S.C. § 352(f), … Read More »
Abbott Off-Label Settlement Facts and Figures
The government has made available materials relating to Abbott’s $1.5 billion settlement. (See link below). Here are some quick observations.
Abbott pled guilty to a misdemeanor for “misbranding” its drug Depakote as a result of off-label promotion. Between January 1998 and December 2006, Abbott promoted Depakote to treat behaviors associated with dementia, but FDA had approved the drug only to treat certain types of epileptic seizures and biopolar mania, and to prevent the onset of migraines. (That’s all according to the Plea Agreement and Agreed Statement of Facts filed in court). Abbott has agreed to pay a criminal penalty of $500 million and an additional forfeiture of $198.5 million.
The documents filed in court as part of the plea indicate that the value of the misbranded drugs was $198.5 million (that’s why the forfeiture was for that amount) and that Abbott … Read More »