William J. Cople addresses ACI's FDA Boot Camp

September 21, 2016-September 23, 2016

Hollingsworth LLP partner Bill Cople addressed the conference on the afternoon of September 22nd at the Omni Park House in Boston.  He and his fellow panelists presented "Ripped from the Headlines: Breaking News, Hot Cases, and Emerging Trends That Impact FDA Practice."  Among the topics covered:

  • The First Amendment and off-label enforcement
  • Update on most recent criminal prosecutions of individuals under DOJ's Yates Memorandum
  • Explore DOJ/SEC investigations, prosecutions, and settlements under the anti-fraud provisions of the federal securities statutes and SEC rules, as well as related liability under the FDCA and False Claims Act for false or misleading statements concerning marketing and clinical use of FDA approved drugs and other products
  • What will the 2016 presidential elections mean for pharmaceutical companies?

Mr. Cople represents government contractors, pharmaceutical and medical device firms, financial institutions, and commodity firms in complex litigation and trials, including product liability, financial fraud, class actions, antitrust and commercial and government contracts.  He handles FDA regulation and enforcement and advises manufacturers on drugs, biologics, devices, vaccines, and food additives including product approval applications, clinical trials, pharmacovigilance, inspections and warning letters, as well as off-label promotion and marketing exclusivity claims.

Now in it's 28th year, ACI's FDA Boot Camp is considered the premier event providing the ultimate road map to the complicated landscape of FDA regulatory law.