Guarding Against Bribery When Conducting Clinical Trials Overseas

Increasingly, pharmaceutical and medical device companies are conducting clinical trials overseas in an effort to cut down on costs.  Many of these trials (needed to support applications to the FDA for the approval of new drugs or devices or the approval of new indications or uses for current drugs or devices) are now taking place in Russia, India, China and Brazil, where the risk of corruption is high.  This shift requires implementation of, and strict adherence to, anti-corruption compliance policies and procedures.  In a guest article, Jacqueline C. Wolff, a partner at Manatt, Phelps & Phillips, discusses the bribery risks associated with such trials and provides an anti-corruption checklist that companies can use to guard against anti-corruption violations.  See also “Ceresney, Focusing on Pharma, Discusses SEC Enforcement Priorities and Compliance Expectations” (Mar. 18, 2015).

To read the full article

Continue reading your article with an ACR subscription.