Food and Drug Law Association CLE Looks at Direct Drug Advertising
Web Editor - Published: October 26, 2011
“I really do think that direct to consumer advertising has changed the playing field,” said Widener Law adjunct Roseann B. Termini at the conclusion of the “Drug Advertising – Ethics and Enforcement” CLE put on by the student Food and Drug Law Association on Tuesday, October 25, 2011 from 12:00 to 2:00 p.m. in the Ruby R. Vale Moot Courtroom on the Delaware campus.

Professor Termini, who formerly served as a deputy attorney general and as corporate counsel for a pharmaceutical company, opened the CLE with a brief history of the creation of the Food and Drug Law Association, saying of student Sarah Alsaleh coming to her about starting the group, “I was honored, but I didn’t know if we could get it together.”

Termini then asked the attendees, “Does a pharmacist have a duty to warn a customer about a dangerous mix of prescription medicines?”

She discussed an Arkansas case, Kowalski v. Rose Drugs of Dardenelle Inc., in which a man died from a cocktail of prescription drugs. Relatives sued the pharmacy that fulfilled the prescriptions, arguing that the pharmacist had a duty to warn the individual of the dangers of combining the drugs. The case ultimately ended up in the Arkansas Supreme Court, which decided that the pharmacist had no duty to warn the individual.

Student Sean Develin, who put the CLE together, then introduced Dr. Darshan Kulkarni, Esq. The principal attorney at the Kulkarni Law Firm, Dr. Kulkarni’s practice focuses on strategic regulatory and pharmaceutical counseling. He previously served as corporate counsel for an international pharmaceutical holding company and has worked as a pharmacist in hospital, retail, and clinical settings. He provides corporate and regulatory legal advice to international pharmaceutical, biopharmaceutical and medical device companies.

Dr. Kulkarni presented “Social Media and Pharmaceuticals”, a talk that examined direct to consumer advertising using social media. He assessed both the pros and cons of using a variety of social media platforms for direct to consumer advertising, as well as the regulatory environment, particularly with regards to FDA enforcement.

Discussing the unintended conflicts that can often occurring when marketing, legal, and compliance departments all have vested interest in a company’s social media policy, Dr. Kulkarni suggested that a company’s legal department needs to say, “Here is what our policy says. Here is what you are allowed to do. Anything else you need to run by us.”

At the conclusion of his remarks, Dr. Kulkarni took questions from the audience. Professor Termini closed the program with a brief power point presentation on the “Duty to Warn and Direct to Consumer Advertising” that summarized and reiterated the points made throughout the program that the duty to warn a patient could fall to the physician, the pharmacist, the manufacturer, or even a medical insurance provider depending on the circumstances.