1. Home
  2. |Insights
  3. |ACI - 3rd Annual Legal, Regulatory and Compliance Forum on Over the Counter Drugs

ACI - 3rd Annual Legal, Regulatory and Compliance Forum on Over the Counter Drugs

Event | 10.27.14 - 10.28.14, 12:00 AM UTC - 12:00 AM UTC

Address

The Carlton Hotel
88 Madison Avenue, New York, NY

The Food and Drug Administration (FDA) announced that the OTC Drug Monograph System and OTC Drug Review Process will be overhauled to meet the current needs of OTC manufacturers. This will revolutionize the OTC drug industry and change the way that over the counter drugs and consumer healthcare products reach the shelves. Billions of dollars are at stake as the OTC drug industry anxiously awaits the FDA’s proposals and ponders how this will impact business practices and profits.

This conference addresses the needs of the OTC drug industry. Legal and regulatory experts in the OTC space will provide you with the critical information you now need to:     

  • Predict how the FDA will implement significant changes to the Monograph System, thereby changing how OTC drugs get approved
  • Extract the fine points of the NSURE Initiative and track the results of increasing access to nonprescription drugs
  • Overcome legal and regulatory hurdles associated with novel Rx-to-OTC switches
  • Reposition your company in light of the recent M&A activity among OTC drug companies
  • Develop social media, advertising, and trademark strategies for OTC drugs while identifying the legal pitfalls
  • Comprehend the importance of patent strategies in the OTC space
  • Appreciate the unique challenges associated with the homeopathic pharmacopeia
  • Understand the implementation of more stringent regulations for pediatric OTCs
  • Develop a global strategy for over the counter drugs

Dick Downing will participate on a panel entitled “Directing Effective Umbrella Branding Tactics for OTC Drug Products and Maximizing the Use of Trademarks and Trade Names.”

For more information, please visit these areas: Intellectual Property, Litigation and Trial, Intellectual Property Litigation

Insights

Event | 02.20.25

Has the Buss Stopped? Recoupment Today

Has the Buss Stopped? Recoupment Today: In 1997, the California Supreme Court decided Buss v. Superior Court. In Buss, the court concluded that a liability insurer that defended a mixed action could seek reimbursement from the insured for the defense costs associated with the claims that were not even potentially covered. Since then, numerous courts have held that insurers are entitled to recoup their defense costs associated with uncovered claims or causes of action. On the other hand, a significant number of courts have rejected insurers’ right to recoupment, at least in the absence of a policy provision granting the insurer that right. Some commentators have even suggested that the current judicial trend might be away from permitting insurers to recoup their defense costs. Is that correct? Has the Buss stopped? This panel of coverage experts will analyze insurers’ claimed right to recoupment today, and offer their perspectives on what the law on recoupment should perhaps be and might be in the future.