In This Issue:

- 2 In the Line Of Fire: Recent FCPA Enforce- ment Efforts

- 8 The New FDA Guidance On Foreign Clinical Trials

- 22 A Bridge To Nowhere: RICO Fraud Consumer Class Actions

Excerpt from Forward:

It is no longer a surprise to read about a pharmaceutical or medical device company being investigated by the United States Department of Justice for violation of the Foreign Corrupt Practices Act. The Department of Justice has set up special teams to investigate the healthcare industry and potential violations of the Act. In the Line of Fire discusses this focus and also gives some timely advice on how to structure a compliance program which will serve you well if your company is investigated.

Plaintiff’s attorneys are always looking for new avenues to bring lawsuits. Racketeering Influenced and Corrupt Organizations Act (RICO) claims against pharmaceutical companies are part of this effort. RICO Class Actions are the focus of A Bridge to Nowhere: RICO Fraud Consumer Class Actions Against Pharmaceutical Manufacturers Post Bridge v. Phoenix Bond.

Clinical studies in foreign countries in support of new pharmaceuticals are now more the norm than the exception. The New Federal Guidance on Foreign Clinical Studies gives some background on the growth of foreign clinical studies, as well as the FDA’s most recent advice as to how best to conduct them.

And don’t miss the second installment of our comprehensive fifty state survey on the local federal court rules on protecting confidential information. This issue contains the remaining twenty-four states and Puerto Rico and, with part one in the February 2012 issue of Pro Te: Solutio, should be a handy reference source.

Our goal in Pro Te: Solutio is not only to keep you abreast of some of the topics important to you, as part of the healthcare industry, but to also offer you some tips and practical suggestions on how to better meet your demanding jobs. We hope this issue attains that goal.