Sunday, June 29, 2014

Dos and Don'ts of responding to Unsoliciated offlabel requests

  • Be specific, truthful, unbiased and scientific
  • Avoid Public responses
  • Keep private response specific to the question
  • Make sure the persons responding on behalf of you are medical or scientific personnel
  • Make sure sales and marketing personnel are not involved at all even in training and awareness
  • Makes sure you are keeping record of all the responses.

Interesting facts

Q  - Is News release about an investigator-lead IND study an off-label promotion?

Ans - Yes and No both. If it is just facts then it is no. But if it contains what you wanted to do with it and what is the derivative product out of it then yes.

Q - Sales people re-twitting a posting about benefits of the product off-label promotion or not ?

Ans - Yes, it should be discouraged.

Q - A consumer forum posting saying negative about our product. What is best way to respond?
Ans - do not necessarily have to respond but if you wanted to respond be more detailed.

Q - Is it ok to post clinical trial information on new uses of our product on

Ans - Yes you should. Post on protocols etc and anything important for your products.