Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices

Speaker: Darshan Kulkarni, Principal Attorney, Kulkarni Law Firm
Dates: August 8-9, 2019
Location: San Diego, CA (Venue to be announced shortly)

Course Description

Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.

What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing.

Seminar Fee Includes:
  • lunch Lunch
  • lunch AM-PM Tea/Coffee
  • lunch Seminar Material
  • lunch USB with seminar presentation
  • lunch Hard copy of presentation
  • lunch Attendance Certificate
  • lunch $100 Gift Cert for next seminar

Learning Objectives

Key goals of the conference will include learning:

  • The basics of FDA law and regulations governing advertising and promotion, as well as sister agencies such as the Federal Trade Commission, which shares jurisdiction with FDA on certain regulated products (e.g., OTC drugs).
  • The distinctions between labels, labeling and advertising and how that impacts FDA's powers, and
  • How to properly position Direct-to-Consumer (DTC) promotions
  • The Dos and Don'ts of promoting products on the internet, including social media sites such as Facebook and Twitter
  • The perils of off-label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies.
  • Whether the First Amendment provides any insulation for truthful statements regarding regulated products;
  • When disseminating medical educational materials crosses the line into improper promotion; and
  • Key considerations on how to implement appropriate procedures and controls in your company to minimize the potential for regulatory action by the FDA or the FTC relative to promotion and advertising.

Day 01(8:30 AM - 4:30 PM)

  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start

  • Understanding the Basics
  • Who Has Jurisdiction
    • Drugs & Biologics
      • Rx Drug Advertising
      • OTC Drug Advertising
    • Devices
      • Restricted
      • all other
  • Labeling vs. Advertising
  • Basic drug rules
    • Fair balance
  • Device rules
    • Intended use deviations
  • DTC advertising
    • Print
    • TV
  • Comparative Claims
    • standard to support
    • push to pursue CER
  • Detailing and Sampling
    • is there still a future?
    • what can be said?
    • danger of “custom” pieces
  • How FDA learns of violations
    • Keep your house clean or your competitors will rat you out
  • Scientific Exchange
  • Guidances on Dissemination of Scientific Information
  • Risks involved in Off-Label Statements
  • Procedural Requirements and Unsolicited Requests for Information
  • First Amendment
  • Understanding “Commercial Speech” Doctrine
  • FDA and the Regulation of Advertising
  • Websites & Social Media
  • FDA Policies on the Internet
  • Recent FDA Enforcement Activities
  • How to Handle at the Company Levels
Day 02(8:30 AM - 4:30 PM)

  • Enforcement Trends
  • FDA Hot Buttons
    • Understating risk
    • Overstating effectiveness
  • FTC
    • POM Wonderful and substantiation
  • Private Litigation – Understanding
    • Lanham Act
    • State Unfair Competition
  • False Claims Act and Criminal Liability
    • Review of Key Settlements
    • Responsible Corporate Official” Liability
  • Handling at the Company Level
    • Compliance Programs
    • Internal processes


Darshan Kulkarni Principal Attorney, Kulkarni Law Firm

Dr. Kulkarni is the Principal Attorney at the Kulkarni Law Firm. As an FDA attorney and product development consultant, 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.

As corporate counsel for an international pharmaceutical holding company, Dr. Kulkarni provided corporate and regulatory legal advice. He has experience in corporate quality control and regularly performs varying legal and regulatory functions, including crafting responses to FDA titled and untited letters, reviewing potential ads, and negotiating with and for advertising agencies and scientific writing agencies.

Price & Registration

Price    :   $ 1,299.00 USD/Registration

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Terms & Conditions to Register for the Seminar:

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +1-646-416-9016 or email us at
Payment is required to confirm your registration.

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email a credit for the amount paid minus administration fees ($300) will be transferred to any future SaleMist event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations.

In the event gets cancelled, SalesMist is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue: After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.