Showing posts with label Pharmaceutical Industry. Show all posts
Showing posts with label Pharmaceutical Industry. Show all posts

Stay Tuned for More

    As have been widely reported (see here for the New York Times article), an FCPA sweep of the pharmaceutical / medical device industry is currently underway. Merck, Medtronic, Zimmer and several other companies are reportedly under investigation.

    For instance, last week Eli Lilly disclosed (here) that it is "in advanced discussions with the SEC to resolve their investigation" that began in August 2003 as to "compliance by Polish subsidiaries of certain pharmaceutical companies, including Lilly, with the [FCPA]."

    AstraZeneca disclosed (here) last week as follows. "As previously disclosed, AstraZeneca has received inquiries from the US Department of Justice and the Securities and Exchange Commission in connection with an investigation into Foreign Corrupt Practices Act issues in the pharmaceutical industry across several countries. AstraZeneca is cooperating with these inquiries and is investigating, among other things, sales practices, internal controls, certain distributors, and interactions with healthcare providers, institutions, and other government officials. AstraZeneca is investigating inappropriate conduct in certain countries, including China."

    Johnson & Johnson, previously included in the group of companies under investigation, resolved an FCPA enforcement action last month (see here for the prior post).

    Many have suggested that J&J's voluntarily disclosed conduct served as the point of entry for the industry wide sweep based on this sentence from the J&J deferred prosecution agreement - "J&J has cooperated and agreed to continue to cooperate with the Department in the Department's investigations of other companies and individuals in connection with business practices overseas in various markets."

    Thus, the J&J enforcement action in many ways provides a glimpse into potential future FCPA enforcement actions involving the pharmaceutical / medical device industry.

    Two issues likely to be found in such future FCPA enforcement actions are discussed below.

    42 USC 1320a-7(a)

    The J&J deferred prosecution agreement states - for why the DOJ agreed to resolve the case the way it did - as follows. "Were the Department to initiate a prosecution of J&J or one of its operating companies and obtain a conviction, instead of entering into this Agreement to defer prosecution, J&J could be subject to exclusion from participating in federal health care programs pursuant to 42 U.S.C. 1320a-7(a)." (See here for those provisions).

    This component of the J&J enforcement is nothing new - as many companies such as Siemens, BAE and others - have escaped the most serious consequences of the alleged criminal conduct because of "who" the companies were (i.e. the products sold and to whom).

    This feature of FCPA enforcement is controversial (for additional reading - see here for my Q&A exchange with former Senator Arlen Specter and here for the recent article titled "FCPA Sanctions: To Big to Debar").

    In recent months, the DOJ has pledged allegiance to the OECD Convention on Bribery to defend certain of its sentencing and "foreign official" enforcement positions (see here for instance).

    Does the OECD Convention say anything about enforcement agencies looking at the unique aspects of an alleged violator and then crafting a resolution to fit that alleged violator?

    Yes it does.

    Article 5 of the OECD Convention (here), under the heading "Enforcement," states that investigation and prosecution of bribery offenses "shall not be influenced by considerations of national economic interest, the potential effect upon relations with another State or the identity of the natural or legal persons involved."

    Health-Care Providers as "Foreign Officials"

    As noted in the prior J&J post (here) the principal FCPA enforcement theory at issue in the pharmaceutical / medical device industry sweep would seem to be the notion that [insert country] had a national healthcare system wherein most [insert country] hospitals are publicly owned and operated and thus health care providers who work at publicly-owned hospitals are government employees providing health care services in their official capacities. According to the DOJ, the individuals are therefore "foreign officials" "as that term is defined in the FCPA."

    Against this backdrop, it is interesting to observe that in the United States approximately 20% of hospitals are owned by state or local governments (see here). In addition, approximately 150 more medical centers are run by the Veterans Health Administration (see here).

    Are we calling 20+% of U.S. health-care providers U.S. officials? If not, why not and why the difference?

    Something to keep in mind as additional pharmaceutical / medical device FCPA enforcement actions burst onto the scene.

Post Title

Stay Tuned for More


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On Point

    Two recent Q&A interviews in Law360 with leading white-collar practitioners caught my eye.

    George Terwilliger (here) is a partner in the Washington D.C. office of White & Case and global head of the firm's White Collar Practice Group. Terwilliger is a former U.S. Attorney, Deputy Attorney General and Acting Attorney General.

    In a recent interview with Law360, Terwilliger was asked "what aspects of law in your practice area are in need of reform, and why?"

    Terwilliger responsed as follows: "I represent many companies who get caught up in the ever-widening net of federal criminal offenses arising from ordinary business activity that runs afoul of government regulatory requirements or dictates. In many such cases, and as in most cases, there is room for reasonable disagreement on the application of relevant legal standards to the salient facts. But because of the collateral consequences of drawn-out investigations and/or of conviction after trial, few if any companies have the opportunity to adjudicate such reasonable disputes before a judge or jury. Consequently, prosecutors, who are entirely appropriately zealous advocates for their side of the case, also become judge and jury in determining an appropriate resolution of the matter. In a system where rule of law is determined by adversarial process, this state of affairs results in an imbalance that is not healthy for the cause of justice."

    Stephen Jonas (here) is a partner in the Boston office of WilmerHale and chairman of the firm's Investigations and Criminal Litigation Practice Group. He is also a former state prosecutor.

    In a recent interview with Law360, Jonas was similarly asked "what aspects of law in your practice are in need of reform, and why?"

    Jonas responded, in pertinent part as follows. "One area greatly in need of reform, in my view, is the investigation of alleged health care fraud. This is an area in which the government regularly secures enormous settlements, starting in the tens of millions of dollars, and now exponentially expanding to the billions of dollars. Virtually every pharmaceutical company has now been subjected to one or more of these investigations and the results are predictable — enormous monetary contributions to the federal government. I find it hard to believe that wrongdoing is so rampant in this industry that every company has at least several hundred million dollars worth of it. The more likely answer is that these settlements often have far more to do with the leverage the government enjoys than the merits of what the company did or didn’t do. In order to stay in business, pharmaceutical and medical device companies must be able to sell products that can be paid for by Medicaid and Medicare. But a conviction for a health care offense would result in exclusion of the companies from federal health insurance and essentially a death sentence for their business. So they cannot afford to fight even the most debatable of charges. One of the results is that novel legal theories and sketchy evidence will never be tested in a court of law and negotiated settlements (under threat of exclusion) serve as “precedent” for the next case. That is a system badly in need of reform."

    One statement is generic, the other relates to health fraud, but both are directly on point when it comes to Foreign Corrupt Practices Act enforcement. (See here for my recent Facade of FCPA Enforcement piece in which I make several similar arguments in terms of FCPA enforcement).

    With the pharma industry sweep currently in full force, Jonas's comments, I suspect, will be even more "on point" in the coming months as numerous pharma and other health care related companies are expected to reach, what will no doubt be, multi-million FCPA settlements that will likely be resolved via resolution vehicles subject to little or no judicial scrutiny. The government will bring in millions, the news will dominate the headlines for a few days, and then the question will be asked - did the conduct at issue even violate the FCPA?

    Richard Cassin at the FCPA Blog recently highlighted a "corporate investigations list" (see here). It listed 72 companies "known to be the subject of an ongoing and unresolved FCPA-related investigation."

    Similar to Jonas, I find it hard to believe that wrongdoing is so rampant that seemingly every major company has at some time run become the subject of FCPA scrutiny or run afoul of the FCPA.

    There is a much bigger picture relevant to this new era of FCPA enforcement and it is this new era that is in need of urgent reform.

    My own two cents, which I will elaborate on in the future, is that the answer to the problem of enforcement agencies enforcing (in many cases) the FCPA contrary to the intent of Congress and based on dubious legal theories is largely not to amend the FCPA - this will solve very little. The more fundamental question remains - how to rein in the enforcement agencies and to force judicial scrutiny of FCPA enforcement actions?

Post Title

On Point


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https://manufacturing-holdings.blogspot.com/2011/01/on-point.html


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SciClone - An FCPA Feeding Frenzy

    On August 9, 2010 SciClone Pharmaceuticals made an FCPA-related disclosure.

    This post discusses what has happened since.

    August 10th

    Shares of SciClone plunged, at one point down 40% from the previous day's close, closing down 31.9%. (This is clearly in stark contrast to the recent situation involving Schlumberger discussed in yesterday's post - here).

    Levi & Korsinsky LLP announce that it is investigating SciClone on behalf of shareholders for possible violations of state and federal securities laws.

    The Law Offices of Howard G. Smith announce that it is investigation SciClone on behalf of shareholders for possible violations of federal securities laws.

    The law firm of Kahn Swick & Foti, LLC announces the commencement of an investigation into SciClone to determine whether it has violated federal securities laws.

    Roy Jacobs & Associates announce that it is investigating SciClone for potentially violating the federal securities laws.

    August 11

    Pomerantz Haudek Grossman & Gross LLP announce that it is investigating claims on behalf of investors of SciClone to determine whether it has violated federal securities laws.

    The law firm of Statman, Harris & Eyrich, LLC announce that it is investigating SciClone for potential violations of state and federal law.

    Goldfarb Branham, LLP announce that it is investigating SciClone for shareholders who purchased stock of the company and preparing a possible derivative lawsuit against company executives.

    Finkelstein Thompson LLP announce that it is investigating potential shareholder claims concerning SciClone.

    August 12

    Robbins Umeda LLP announce that it commenced an investigation into possible breaches of fiduciary duty and other violations of the law by certain officers and directors at SciClone.

    August 13

    The law firm of Kahn Swick & Foti announce that the firm has filed the first securities fraud class action lawsuit against SciClone in the United States District Court for the Northern District of California, on behalf of purchasers of the common stock of the Company between May 11, 2009 and August 10, 2010.

    August 19

    Barroway Topaz Kessler Meltzer & Check, LLP announce that a class action lawsuit was filed in the United States District Court for the Northern District of California on behalf of purchasers of the securities of SciClone.

    Brower Piven, A Professional Corporation, announce that a class action lawsuit has been commenced in the United States District Court for the Northern District of California on behalf of purchasers of the common stock of SciClone.

    August 20

    Kendall Law Group announce an investigating of SciClone for shareholders.

    Ryan & Maniskas, LLP announce that a class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of purchasers of SciClone.

    August 28

    Roy Jacobs & Associates (again) announce that it is investigating SciClone for potentially violating the federal securities laws.

    September 7

    The Shuman Law Firm announces that a class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of anyone who purchased or otherwise acquired SciClone common stock between May 11, 2009and August 10, 2010.

    September 8

    Kaplan Fox & Kilsheimer LLP announce that it has filed a class action suit against SciClone alleging violations of the Securities Exchange Act of 1934 on behalf of purchasers of SciClone's common stock during the period May 11, 2009 and August 9, 2010.

    September 16

    The law firm of Strauss & Troy announce that a class action lawsuit has been filed in the U.S. District Court for the Northern District of California against SciClone for potential violations of state and federal law.

    September 23

    The law firm of Lieff Cabraser Heimann & Bernstein, LLP announce that class action lawsuits have been brought on behalf of purchasers of the common stock of SciClone.

    Given the above, you are probably wondering, geez, what did SciClone disclose - how extensive were the disclosed FCPA violations? Did the company's CEO or CFO resign? Is the company still in business?

    Well, not exactly.

    On August 9th, SciClone disclosed (see here) as follows:

    "On August 5, 2010 SciClone was contacted by the SEC and advised that the SEC has initiated a formal, non-public investigation of SciClone. In connection with this investigation, the SEC issued a subpoena to SciClone requesting a variety of documents and other information. The subpoena requests documents relating to a range of matters including interactions with regulators and government-owned entities in China, activities relating to sales in China and documents relating to certain company financial and other disclosures. On August 6, 2010, the Company received a letter from the DOJ indicating that the DOJ was investigating Foreign Corrupt Practices Act issues in the pharmaceutical industry generally, and had received information about the Company’s practices suggesting possible violations."

    During SciClone's August 9th earnings conference call Friedhelm Blobel (President and CEO) stated that SciClone "intends to cooperate fully with the SEC and DOJ in the conduct of their investigations, and has appointed a special committee of independent directors to oversee the Company's efforts." Blobel noted that "as far as timing is concerned, the lawyers tell us that these investigations typically are long lasting." In response to the question - is the investigation disrupting day-to-day operations or ongoing sales, Gary Titus (CFO) said that "it is business as usual for SciClone, and we continue to focus on all of the priorities that we have set for the Company ..."

    That's right.

    All of the above occured because the SEC initiated a formal investigation of SciClone and issued a subpoena to the company and because SciClone received a letter from the DOJ as to an industry-wide investigation suggesting possible improper conduct by the company.

    You be the judge.

    Are the above referenced investigations and lawsuits a rational and value added exercise for shareholders of SciClone or rather indicative of an FCPA feeding frenzy where everyone, it seems, is trying to get a slice of the pie?

    Has this all gotten a bit out-of-hand?

    *****

    Yesterday, SciClone (see here) announced "continued topline growth and strong cash position in the Third Quarter of 2010."

Post Title

SciClone - An FCPA Feeding Frenzy


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https://manufacturing-holdings.blogspot.com/2010/10/sciclone-fcpa-feeding-frenzy.html


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DOJ Speaks

    There is a "same speech, different day" aspect of late when the DOJ talks about the FCPA. One can reasonably predict what will be said (i.e. DOJ values voluntary disclosure and cooperation), even before it is said, and this has the tendency of diminishing the message.

    This week it was Compliance Week 2010 (see here). The speaker's - Acting Deputy Attorney General Gary Grindler and Assistant Attorney General (Criminal Division) Lanny Breuer.

    *****

    On Tuesday, Grindler spoke (see here for his remarks).

    Grindler began his remarks as follows:

    "Having spent a good portion of my career in private practice representing corporate clients and advising them on compliance matters, I am no stranger to what I suspect many of you in the audience are thinking: What is the Department of Justice focused on and how can I make sure my clients stay as far away from it as possible? I’d like to spend my time with you this evening hopefully answering the first question by giving you a sense of some of the policy and enforcement priorities that we are focused on at the Department and sharing some of my thoughts how you can best position your clients when interacting with the Department."

    Grindler's remarks covered three general topics: DOJ's Financial Fraud Enforcement Task Force, DOJ's efforts to combat health care fraud, and the DOJ's new Intellectual Property Enforcement Task Force.

    While speaking on health care fraud, Grindler noted:

    "You can be assured that we will also use every tool at our disposal to investigate and prosecute corrupt practices in the pharmaceutical industry. In the months ahead, for example, you can expect to see the Department increasingly use the Foreign Corrupt Practices Act to prosecute kickbacks and bribes paid to foreign government officials by pharmaceutical companies. As the drug companies do more and more of their business overseas where so much of the health care business is government run, we see the opportunities for FCPA violations unfortunately proliferating. Indeed, in some foreign countries nearly every aspect of the approval, manufacture, import, export, pricing, sale and marketing of a drug product may involve a “foreign official” within the meaning of the FCPA. The extent of government involvement in foreign health systems, combined with fierce industry competition and the closed nature of many public formularies, creates, in our view, a significant risk that corrupt payments will infect the process. The Department will not hesitate to charge pharmaceutical companies and their senior executives under the FCPA if warranted to root out foreign bribery in the industry."

    For the same speech, different day version, see here and here.

    The final part of Grindler's speech is titlted - "What You Can Do." Excerpted portions are below.

    "Now, how can you best advise your clients in light of the Department’s enforcement priorities and given the climate we are in where there is so much distrust of corporate America."

    "First, you can make sure that your clients have robust, effective compliance programs and internal controls. A company’s compliance program continues to be one of the most important factors that we consider under the Principles of Federal Prosecution of Business Organizations. You are on the front lines of this issue and can make a real difference in your respective institutions by sending the message about the need for an effective compliance program. Compliance programs must not exist only on paper."

    "In this context, I want to point out that the United States Sentencing Commission recently amended the Sentencing Guidelines on the issue of compliance programs. Specifically, the Commission clarified the importance of assessing and modifying compliance programs after you discover criminal conduct at your company. The current Guidelines provide that, following the discovery of criminal conduct, a company should, among other things, make “any necessary modifications to the organization's compliance and ethics program.” The new amendment -- assuming it goes into effect in November -- provides a new commentary to that provision specifying that this post-violation process includes “assessing the compliance and ethics program and making modifications necessary to ensure the program is effective … and may include the use of an outside professional advisor to ensure adequate assessment and implementation of any modifications.”

    "In addition, the latest Guideline amendments clarify the circumstances under which an effective compliance and ethics program can entitle an organization to a 3-level reduction in its culpability score. Specifically, the amendment allows an organization to receive the decrease if the organization meets four criteria: (1) the individual or individuals with operational responsibility for the compliance and ethics program have direct reporting obligations to the organization’s governing authority or appropriate subgroup thereof; (2) the compliance and ethics program detected the offense before discovery outside the organization or before such discovery was reasonably likely; (3) the organization promptly reported the offense to the appropriate governmental authorities; and (4) no individual with operational responsibility for the compliance and ethics program participated in, condoned, or was willfully ignorant of the offense. These amendments reinforce the point that having a robust compliance program is critical not only to preventing misconduct in the first place, but also how your organization will be treated in the event criminal conduct does take place."

    "The second thing you can do to best position your client, is you can partner with us. As I hope has been clear in my discussion of our enforcement efforts, there is a consistent theme of the importance of sharing information and partnering with the private sector in its anti-fraud efforts. Through examples like the National Heath Care Fraud Summit and the regional mortgage fraud summits, we have been reaching out to private sector anti-fraud professionals to share information about fraud schemes and improvements in data analysis. While we have limitations in what we can share, we are interested in exploring ways to work together within those constraints. If the private sector sees new fraud schemes or ways in which we can prevent fraud, that is something you should share with us."

    "Third, you can advise your clients to make early, voluntary disclosure of misconduct. As you know, it is usually in your client’s best interest to cooperate with the government’s investigation through the disclosure of relevant facts, the production of documents and other evidence, and making witnesses available who have relevant information."

    "Fourth, you can guide your client’s decision to take meaningful remedial measures in response to criminal wrongdoing, including the payment of restitution and the disciplining or termination of culpable employees, officers, or directors."

    "In the end, all of these steps – robust compliance programs, information sharing between public and private sector anti-fraud efforts, voluntary disclosure, and meaningful remedial measures -- will inure to the benefit of your clients in several significant ways. They will deter criminal conduct from occurring in the first place. They will ensure that if and when misconduct does occur, it is detected early on and can be rooted out before too much damage is done. Your client will receive credit for such actions during the prosecutorial decision-making process. Finally, such steps will make your clients stronger corporate citizens, and will empower your clients’ officers, directors, and employees to fulfill their fiduciary obligations to shareholders and their duties of honest dealing to the investing public and the taxpayers."

    For more on Grindler's speech, including topics raised during the Q&A, see this piece from Christopher Matthews at Main Justice.

    *****

    On Wednesday, Breuer spoke (see here for a copy of his remarks). Below are various excerpts from the speech.

    Given the DOJ's recent "bribery, yet no bribery" cases against BAE and Daimler, I must admit to getting a bit frazzled after only paragraph two of the speech in which Breuer talks about the "the Justice Department’s determination to prosecute – and prosecute aggressively – financial fraud and corruption in all its forms. The American public demands no less, and we will deliver no less."

    Speaking generally, Breuer described "a new era of heightened white-collar crime enforcement – an era marked by increased resources, increased information-sharing, increased cooperation and coordination, and tough penalties for corporations and individuals alike."

    Breuer next discussed that "additional resources are also being committed in the Criminal Division, where we are in the process of adding a number of attorneys to the Fraud Section – lawyers who will be deployed immediately to prosecute crimes like securities fraud, health care fraud, and foreign bribery under the Foreign Corrupt Practices Act." He cited the Africa Sting case as an example of using "more aggressive law enforcement techniques" and further stated that "it is fair to say that [DOJ] will continue to look for opportunities to innovate in how we identify financial fraud and corruption."

    Speaking of innovation at the SEC, Breuer stated:

    "The SEC will now make use of cooperation agreements, as well as deferred and non-prosecution agreements – all of which have been staples of the Justice Department’s approach in white collar criminal cases for many years now. These innovations will likely lead to even earlier and closer coordination between the SEC and the Justice Department."

    Breuer next talked specifically about foreign bribery "which obviously is at the center of this heightened enforcement climate and which presents unique compliance challenges."

    Below are his remarks.

    "As I have said in the past, foreign bribery is a law enforcement challenge of truly global dimensions. It is, as the Attorney General has said, a 'scourge on civil society.' We in the Criminal Division combat foreign bribery each and every day. And as we go about our business, we are looking carefully at lapses in corporate compliance. Why? Because of what I said a few minutes ago. Our preference, like yours, is for these crimes to be prevented in the first instance. And the only way that can happen in your organizations is through a robust, state-of-the-art compliance program and a true culture of compliance."

    "I know that you all do not lack for incentives; the statistics in FCPA enforcement are well known. But it is worth pausing on them for a moment."

    "Since 2004, the Fraud Section has achieved 37 corporate FCPA and foreign bribery related resolutions, with fines totaling over $1.5 billion. In this time period, we have charged 81 individuals with FCPA violations and related offenses. Forty-six have been charged since the start of 2009 – more than the total number of individuals charged in the previous seven years combined."

    "The individuals charged have included CEOs, CFOs, other senior-level corporate officials and, where jurisdiction existed here, several foreign officials. Charging individuals is part of a deliberate enforcement strategy to deter and prevent corrupt corporate conduct before it happens. And rest assured that we will seek equally tough sentences, including significant jail time if appropriate, to reinforce this message of deterrence."

    "Aggressive enforcement by the Criminal Division provides one set of incentives for corporations. Others are sprouting up each and every day, and they are coming from all corners as anti-fraud and corruption enforcement catches up with the globalization of business."

    "Here in the United States, the United States Sentencing Commission recently approved amendments to its Sentencing Guidelines, one of which reaffirmed the importance of compliance and ethics programs within organizations. The amendment stressed the critical need to embed these programs at the very highest level of the organization. In an interesting twist, the Commission expanded eligibility for effective compliance and ethics program credit at sentencing even if one or more members of 'high level personnel' has some role in the offense."

    "But there’s a catch. In order to be eligible for credit where there is such 'high level' involvement, the corporation must have in place a direct reporting relationship between the individual with operational responsibility for the compliance program and the corporation’s governing body. And more than that, the corporation must have discovered the offense and reported it to enforcement officials before it otherwise became known. The amendment has not been uncontroversial. But whatever your opinion, it can at least be said that the amendment reflects the Commission’s view that compliance should be embedded at the very highest levels of an organization."

    "On the international front, the United Kingdom has passed a new, comprehensive Bribery Act that criminalizes, among other things, the failure by a corporate entity to prevent bribery. Pretty serious, right? Well, the Act does provide a defense to such a charge if the corporate entity can show that it has 'adequate procedures' in place to deter and detect such conduct. What does 'adequate procedures' mean? It’s not entirely clear. And I’m, of course, not your lawyer. But, at a minimum, it would seem prudent to have in place a strong, state-of-the-art compliance program."

    Breuer then offers a few thoughts on compliance and offers up the Principles of Federal Prosecution of Business Organizations (see here) and the OECD’s Good Practice Guidance on Internal Controls, Ethics, and Compliance (see here - Annex II) as benchmarks.

    Breuer then acknowledges that "even the best compliance program may not stop fraud or corruption from occurring. So, what should a corporation do when a problem has been discovered?"

    Because the answer has been stated numerous, numerous times, you probably already known the answer - voluntarily disclose and cooperate.

    Below are Breuer's comments on these issues:

    "Whether to voluntarily disclose potential criminality is admittedly a difficult question for business entities."

    "But I can offer you this: If you come forward and if you fully cooperate with our investigation, you will receive meaningful credit for having done so. In talking about 'meaningful' credit, we are not promising amnesty for doing the right thing. But, self-reporting and cooperation carry significant incentives – by working with the Department, no charges may be brought at all, or we may agree to a deferred prosecution agreement or non-prosecution agreement, sentencing credit, or a below-Guidelines fine. Ultimately, every case is fact-specific and requires an assessment of the facts and circumstances, as well as the severity and pervasiveness of the conduct and the quality of the corporation’s pre-existing compliance program. But, in every case of self-disclosure, full cooperation, and remediation, the Department is committed to giving meaningful credit where it’s deserved to obtain a fair and just resolution."

    "The Siemens matter is a case in point. While the conduct in that case is arguably the most egregious example of systemic foreign corruption ever prosecuted by the Department, [Note - Siemens was not charged with violating the FCPA's anti-bribery provisions] it also illustrates the tremendous benefits that flow from truly extraordinary cooperation. By Siemens opening itself up to authorities, [Note - Siemens did this after its offices were raided by German authorities] the Department completed its investigation and resolved the case – with domestic and international dimensions – in two years’ time. In the end, the benefits Siemens received through its cooperation, even in the absence of a voluntary disclosure, were plain – the $450 million fine that was paid to the Justice Department, although quite substantial, was a far cry from the advisory range of $1.35 billion to $2.7 billion called for in the Sentencing Guidelines. Put another way, Siemens received a penalty that was 67 to 84 percent less than what it otherwise could have faced had it not provided extraordinary cooperation and carried out such extensive remediation."

    "Another example, on a more modest scale, was the resolution of the Helmerich & Payne matter, a company that self-disclosed improper or questionable payments. [Note - is Breuer acknowledging that the payments at issue in this case - payments to various officials and representatives of the Argentine and Venezuelan customs services in connection with importation and exportation of goods and equipment - may not have violated the FCPA? See here for more] The case was resolved through a non-prosecution agreement with a term of two years, a penalty of $1 million (which was approximately 30 percent below the bottom of the Guidelines range), and compliance self-reporting by the company for a period of two years in lieu of an independent compliance monitor. Because of the forward-leaning, proactive, and highly cooperative approach taken by Helmerich & Payne, that company received a host of benefits that likely would not otherwise have been obtained from the Department."

    "In short, these two cases, and others like them, reflect the Department’s willingness to step up to the plate when a corporation does the right thing by making a voluntary disclosure and cooperating fully."

    "Let me offer one additional piece of guidance on this topic. When a problem has been discovered, the corporation should seriously consider seeking the government’s input on the front end of its internal investigation. [Note - at the front end of an FCPA internal investigation, it is generally not even known if a violation has occurred - why should a company seek the DOJ's input when it is not yet known if a violation of law has occurred?] We encourage a company to come in and describe its work plan for conducting the investigation. Often we have questions, or helpful suggestions, or we may ask that the corporation expand the scope of the investigation. Regardless, the dialogue can be very helpful in ensuring at the outset that the corporation has an effective, cost-effective plan in place to investigate and deal with the problem."

    Breuer then offered a few words about compliance monitors.

    Below are his comments.

    "In resolving criminal conduct, the Department’s goal is to vindicate the law and ensure adherence to it in both letter and spirit. In that regard, the structure and terms of a corporate resolution are properly determined by the particular facts of the case and the circumstances surrounding the specific business entity and the public interest. Thus, a compliance monitor may be particularly useful where the agreement requires the corporation to design, or substantially re-design, and implement a broad compliance and ethics program and internal controls. As an independent observer, the monitor can enable the government to verify whether a business is fulfilling the obligations to which it agreed. In other cases, however, a compliance monitor may not be needed for a variety of reasons, such as where the business organization has ceased operations in the area where the criminal conduct occurred, or where the business has re-designed and effectively implemented appropriate compliance measures and internal controls before entering into an agreement with the United States."

    "However the calculus plays out, we are always mindful of, and we do weigh, the potential benefits of employing a monitor with the cost of a compliance monitor and its impact on the operations of the business organization. Of that much you can be sure."

    For more on Breuer's speech, including topics raised during the Q&A, see this piece from Christopher Matthews at Main Justice.

    *****

    A good holiday weekend to all - please check back on Tuesday for a post about a current FCPA compliance monitor.

Post Title

DOJ Speaks


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https://manufacturing-holdings.blogspot.com/2010/05/doj-speaks.html


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A Few Questions From the Back Row

    Today, Assistant Attorney General Lanny Breuer gave a keynote address to the 10th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum (see here for his address).

    In addition, to talking about the unique FCPA compliance risks facing the pharmaceutical industry, Breuer also discussed general FCPA topics such as compliance and voluntary disclosure. Whether you are in the pharma industry or not, you probably want to take a look at what he had to say.

    Here is what Breuer had to say about the "foreign official" element of an FCPA anti-bribery violation.

    "...who exactly qualifies as a 'foreign official' in the context of a public health system, and what constitutes a corrupt offer or payment that violates the FCPA? Of course, the answers to those questions depend on the facts and circumstances of every case, and I can't give you binding guidance from the podium today."

    Breuer also said:

    "...consider the possible range of 'foreign officials' who are covered by the FCPA: Some are obvious, like health ministry and customs officials of other countries. But some others may not be, such as the doctors, pharmacists, lab technicians and other health professionals who are employed by state-owned facilities. Indeed, it is entirely possible, under certain circumstances and in certain countries, that nearly every aspect of the approval, manufacture, import, export, pricing, sale and marketing of a drug product in a foreign country will involve a 'foreign official' within the meaning of the FCPA."

    If I had attended the address, I would have raised my hand and asked these questions (perhaps someone did).

    Why can't the DOJ give binding guidance (or even just guidance) on the meaning of the "foreign official" element?"

    You say that "doctors, pharmacists, lab technicians and other health professionals who are employed by state-owned facilities" are included in the range of "foreign officials who are covered by the FCPA." However, isn't that merely the DOJ's interpretation of the statute, and an untested and unchallenged interpretation at that? Before companies are subject to an FCPA enforcement action based on this theory, shouldn't there at least be some judicial acceptance of this theory? If you believe there has been, can you please provide the case cites? Is DOJ willing to make public its legal analysis and rationale for this theory?

Post Title

A Few Questions From the Back Row


Post URL

https://manufacturing-holdings.blogspot.com/2009/11/few-questions-from-back-row.html


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Pfizer Under Scrutiny in the Philippines

    A question often posed at FCPA conferences to U.S. enforcement attorneys is - "how do you find out about potential FCPA violations?" The usual answers are: a company self-reports, a competitor or disgruntled employee blows the whistle, or foreign law enforcement agencies contact the DOJ or SEC. I've never heard though of a foreign legislator issuing a press release and sending a letter to the DOJ and the Commerce Department accusing a U.S. company of violating the FCPA. That is until now.

    Earlier this week, Senator Mar Roxas (Philippines) issued a press release (see here) demanding that Pfizer Inc. open its records to a congressional committee investigating Pfizer's lobbying of the Philippine government in connection with the passage and implementation of the Cheaper Medicines Law (the "Law"). In addition, the release notes that Roxas also sent separate letters to the U.S. Department of Justice and the U.S. Commerce Department. According to the release, in the letters Roxas states his belief that Pfizer's activities in connection with passage and implementation of the Law "are unethical and violate not only Philippine Anti-Corruption Laws, but also the U.S. Foreign Corrupt Practices Act" and he specifically requests "any assistance that [the DOJ] can extend in looking into allegations of bribery against Pfizer...".

    Time will tell whether a future FCPA enforcement action against Pfizer is on the horizon. If there is one, it will not be the first time a U.S. company is subjected to FCPA scrutiny for its efforts to influence foreign legislation impacting its business. In January 2005, Monsanto Co. agreed to pay $1.5 million to settle an FCPA enforcement action based on allegations that it made improper payments to a senior Indonesian environmental official to persuade the official to repeal an environmental impact study requirement that was making it difficult for the company to sell its genetically modified crops in that country. (See here, here and here).

Post Title

Pfizer Under Scrutiny in the Philippines


Post URL

https://manufacturing-holdings.blogspot.com/2009/07/pfizer-under-scrutiny-in-philippines.html


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