On-the-Job Training: How to Stay On Top of Compliance Requirements and Industry Standards, in Pharmaceutical Compliance MonitorJuly 26, 2013
George B. Breen, Chair of the firm's National Health Care and Life Sciences Practice Steering Committee, and Natasha F. Thoren, an Associate in the Health Care and Life Sciences practice, wrote an article titled "On-the-Job Training: How to Stay On Top of Compliance Requirements and Industry Standards."
Following is an excerpt:
Given the ever-increasing pursuit of the pharmaceutical industry by federal regulators, compliance professionals must strive to stay up-to-date on industry standards and compliance obligations. However, the reality of expanding job responsibilities in the face of time and budgetary pressures makes knowing where to look to stay informed critical.
There are a number of valuable resources that compliance officers might use to help their companies survive in this challenging enforcement climate.
Pharmaceutical Investigations and Settlements
Government enforcement of pharmaceutical companies has increased over the last several years. At any moment, a pharmaceutical company may be facing an investigation by the U.S. Department of Justice (DOJ), stemming from a whistleblower complaint under the False Claims Act, a potential violation of the Anti-Kickback Statute, the federal Food, Drug Cosmetic Act or, increasingly, the Foreign Corrupt Practices Act.
Awareness of current and past investigations and/or settlements provides some insight into the areas that the agencies regulating the industry are keen on investigating, and allows compliance professionals to evaluate their own company's policies and processes before they become the subject of an investigation.
Reviewing reports of investigations and key settlement documents can be helpful in identifying potential risk areas within your own organization. Cases and settlements can be found at the following websites: DOJ (http://www.justice.gov/publications/case-highlights.html); the Federal Trade Commission (http://www.ftc.gov/os/caselist/index.shtm); the U.S. Department of Health and Human Services (HHS) (https://oig.hhs.gov/compliance/corporate-integrity-agreements/cia-documents.asp); and the U.S. Securities and Exchange Commission (http://www.sec.gov/spotlight/fcpa/fcpa-cases.shtml).