A discussion with Darshan Kulkarni, Principal Attorney at the Kulkarni Law Firm (see Bio), about recent court cases involving pharma's right to speak to physicians about off-label uses of approved drugs.
In a 2-to-1 split decision, the 2nd U.S. Circuit Court of Appeals in New York on Monday threw out the conviction of a sales representative for promoting off-label use of a prescription drug.
The majority decision written by Circuit Judge Denny Chin -- the same judge that rejected Google's deal to digitize books -- was based on last year's Supreme Court ruling that "Speech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment." According to Judge Chin, the "pharmaceutical representative's promotion of an FDA-approved drug's off-label use is speech" and he was prosecuted "precisely" because of his "speech in aid of pharmaceutical marketing." Ergo, "we VACATE the judgment of conviction and REMAND the case to the district court."
There's enough legal issues in this case to keep a ship-load of constitutional and pharma lawyers busy for years. But I'd like to look at this from a different perspective -- i.e., what pharma has to gain from this and what patients have to lose.
This particular case involves several off-label discussions between a sales rep and a physician who recorded the conversations. The drug being promoted by the sales rep was Xyrem, a powerful central nervous system depressant, approved for "narcolepsy patients who experience cataplexy" and "narcolepsy patients with excessive daytime sleepiness." Xyrem's active ingredient is gamma-hydroxybutryate ("GHB"). GHB has been federally classified as the "date rape drug" for its use in the commission of sexual assaults. Xyrem can cause serious side effects and, if abused, it can cause additional medical problems, including seizures, dependence, severe withdrawal, coma, and death. It's FDA labeling includes a "black-box" warning.
Please review the recent court case regarding off-label communications
Are pharma sales now free to talk about off-label indications? Or should pharma wait for reaction from FDA?
Has this decision affected FDA's timeline for developing social media guidelines? If so, how so?
How will this case and others make it easier for pharma companies to deal with future off-label litigation and negotiations with the DOJ?
What are the possible next steps in this leagl battle?
Dr. 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.