Is off-label promotion of ISF legal?
A New York court has ruled that free speech trumps off-label discussions.
It was this news that prompted attorney Darshan Kulkarni of Kulkarni Law Firm to send me this tweet:
What happened?
On Monday, a federal appeals court in New York announced the ruling of an ISF in promoting off-label use of a drug.
Judge Denny Chin wrote:
"In the fields of medicine and public health information can save lives, it only serves the public interest to ensure choices about the use of prescription drugs, this also includes off-label use, if done in intelligent and well-informed way."
The ruling essentially follows the notion that: "The more information available to everyone, the better." "If doctors can discuss alternative uses of drugs, others should be able to do the same."
Darshan and yours truly reported in September on the subject of recent FDA guidance, "In Response to Information Requests on Off-Label Use, Rx Drugs, and Medical Devices." Darshan predicted this would happen by reporting the case IMS Health v. Sorrel in which the Supreme Court decision stated that the Government cannot restrict freedom of speech. (Sorrell v IMS extension Health Inc., No. 10-779 131 S.Ct. 2653 (2011), was a case in which the Court Supreme of States United stated that a law of Vermont That had limited the sale, disclosure and use of acts which revealed the prescribing practices of the individual doctors I had violated
