{"id":12658,"date":"2014-01-01T00:00:00","date_gmt":"2014-01-01T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/uncategorized\/show143\/"},"modified":"2014-01-01T00:00:00","modified_gmt":"2014-01-01T00:00:00","slug":"show143","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/talk\/show143\/","title":{"rendered":"Responding to Unsolicited Requests for Off-Label Information: Pharma Citizen Petition Calls for New Regulations"},"content":{"rendered":"

Responding to Unsolicited Requests for Off-Label Information Pharma Citizen Petition Calls for New RegulationsClick Here for Additional Resources<\/a><\/p>\n

A conversation with Darshan Kulkarni<\/b> (see bio<\/a>), Principal Attorney, Kulkarni LLC<\/a> (see bio<\/a>), focusing on the recent Citizen Petition filed with the FDA by seven major pharmaceutical companies asking for new regulations regarding the dissemination of off-label product information and other communications with healthcare professionals.<\/p>\n

Aired LIVE on: Tuesday, July 19, 2011<\/b> Listen to internet radio<\/a> with Pharmaguy<\/a> on Blog Talk Radio<\/p>\n

You may also visit this Pharma Marketing Talk Segment Page<\/b><\/a> to listen to the audio podcast.<\/p>\n

This show and ALL Pharma Marketing Talk shows are available as podcasts via PMT on iTunes<\/b><\/a> (FREE!).<\/p>\nBackground<\/b><\/p>\n

Allergan, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, Novo, and Sanofi-Aventis filed a “citizen petition” with the FDA yesterday, urging the agency to “establish comprehensive, clear and binding regulations to guide the industry” in communicating off-label drug information to physicians and payers.<\/p>\n

The petition requests that FDA issue clarifying regulations on four separate, but related issues:<\/p>\n

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  1. Manufacturer responses to unsolicited requests — mostly requests for off-label information. Specifically asks for a “safe harbor” defining what constitutes a “non-promotional response.”<\/li>\n
  2. “Scientific exchange” — specifically asks to clarify what FDA means by this<\/li>\n
  3. Interactions with Formulary Committees, Payors, and Similar Entities — specifically asks for clarity on sharing health care economic and other drug information<\/li>\n
  4. Dissemination of Third-Party Clinical Practice Guidelines — specifically guidelines that may discuss off-label uses of drugs. <\/li>\n<\/ol>\nQuestions\/Topics To Be Discussed<\/b> <\/p>\n