Editor's Note: Clinical trials sponsored by pharmaceutical and medical device companies are generally intended to obtain data that support applications to the Food and Drug Administration (FDA) for the approval of new drugs or devices or new indications for currently marketed drugs or devices. In part, to cut down on costs, U.S. life sciences companies are increasingly conducting clinical trials overseas—frequently in countries such as Russia, India, China and Brazil where the risk of corruption is high.
The shift to overseas clinical trials requires stricter implementation of, and adherence to, anticorruption policies and procedures—a need that's heightened by the likely increase in U.S. government oversight in the future. In a new article in the FCPA Report, summarized below, Manatt outlines six steps to address corruption risk in connection with overseas clinical trials. Click here to download a free PDF of the full article.
United States v. Syncor Taiwan, Inc. was the first publicized case of a pharmaceutical company being held responsible for violations under the FCPA based on providing items of value to physicians employed by overseas state-owned hospitals to influence them to prescribe Syncor's drugs. Since Syncor, there have been many life sciences companies caught in the crosshairs of FCPA and local anticorruption law investigations.
To date, no cases have been publicly brought alleging payments to clinical trial investigators in exchange for reporting positive outcomes. This does not mean, however, that life sciences companies should be complacent. Recent activity suggests that the DOJ may be starting to focus on overseas clinical trials. Now would be a good time, therefore, to review clinical trial practices overseas. There are six steps important to consider when addressing corruption risk. (Click here to read the full FCPA Report article, which describes the six steps in detail.) In short:
- Consider the necessity of the trial.
- Evaluate the proposed trial site and patient population.
- Review the trial protocol and conduct anticorruption due diligence on investigators.
- Ensure appropriate representations are included in the clinical trial agreements.
- Maintain vigilance throughout the trial including being mindful of fair market value of investigator meeting payments.
- Impose the same obligations on a clinical research organization.
Overseas clinical trials are increasingly a common part of the global economy. Implementing an anticorruption program now can prevent costly headaches down the road.