Responding to Unsolicited Requests for Off-Label Information Pharma Citizen Petition Calls for New RegulationsClick Here for Additional Resources

A conversation with Darshan Kulkarni (see bio), Principal Attorney, Kulkarni LLC (see bio), 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.

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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.

The petition requests that FDA issue clarifying regulations on four separate, but related issues:

  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.”
  2. “Scientific exchange” — specifically asks to clarify what FDA means by this
  3. Interactions with Formulary Committees, Payors, and Similar Entities — specifically asks for clarity on sharing health care economic and other drug information
  4. Dissemination of Third-Party Clinical Practice Guidelines — specifically guidelines that may discuss off-label uses of drugs.

Questions/Topics To Be Discussed

  • Provide an overview of the petition.
  • Why Guidance vs regulation, which is best for pharma? Why does petition specifically ask for new regulations? What’s the first amendment repercussions?
  • Considering that FDA is currently working on guidance regarding unsolicited requests for information (online and offline), what impact does this have on FDA’s guidance timeline?

Guest Bio

Darshan KulkarniDr. Darshan Kulkarni is the Principal Attorney at the Kulkarni Law Firm. He focuses on strategic regulatory and pharmaceutical counseling and has extensive experience handling the needs of international pharmaceutical, biopharmaceutical and medical device companies and their service providers, including Contract Manufacturing Organizations and Contract Research Organizations.

As Corporate Counsel for a reputable, international pharmaceutical holding company, Dr. Kulkarni provided corporate and regulatory legal advice to international pharmaceutical, biopharmaceutical and medical device companies. He has had experience in corporate quality control and has worked in varying legal and regulatory areas including crafting responses to FDA 483s, FDA recalls, and negotiating with and for CROs and sponsors.

In addition, Dr. Kulkarni has worked as a pharmacist in multiple capacities, including hospitals, retail pharmacies, managed care, and and has even participated as a clinician in clinical trials.

Additional Resources