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In the SciClone Pharmaceuticals FCPA case, the company agreed to pay more than $12 million to settle allegations that its subsidiaries used money, gifts and other benefits to increase pharmaceutical sales to China’s state health institutions. The Securities and Exchange Commission alleged that sales representatives openly described vacations, expensive meals and entertainment alongside the prescriptions they expected to gain. For someone inside sales, medical affairs or finance, the revealing detail is that split between what the sales reports said the spending bought and what the books called it.
The Commission resolved the foreign-bribery case through an administrative order dated February 4, 2016. It alleged violations of the Foreign Corrupt Practices Act’s anti-bribery, books-and-records and internal accounting controls requirements. The order described a California-headquartered pharmaceutical company whose products were primarily marketed and sold in China, with improper benefits extending from at least 2007 through 2012.
The order described SciClone’s wholly owned subsidiary, SciClone Pharmaceuticals International, as conducting the China sales and marketing activities. Some parent-company officers also served as subsidiary officers or directors, traveled frequently to China to participate in its management, and negotiated contracts with Chinese distributors. According to the order, the parent approved marketing budgets and consolidated the subsidiary’s accounts into its own financial statements. That connected a local employee’s expense report to the public company’s books.
Public-hospital purchasing decisions help explain the opportunity for pharmaceutical bribery. In the 2015 Securities and Exchange Commission remarks FCPA, Disclosure, and Internal Controls Issues Arising in the Pharmaceutical Industry, the agency’s enforcement director described how doctors, pharmacists and administrators at public hospitals often decide which products those institutions purchase. SciClone’s order specifically identified healthcare professionals employed by state-owned hospitals as recipients of the alleged benefits. Their prescribing influence was part of the sales opportunity.
The Commission alleged that sales representatives treated high-prescribing healthcare professionals as VIP clients and reported their prescription volumes to subsidiary management. It also alleged that certain managers knew about and encouraged the practice. The order tied the entertainment to the commercial return, quoting one sales manager’s description:
luring them with the promise of profit.
The examples were unusually direct. The order described surgical VIP clients, including hospital presidents, attending the Qingdao Beer Festival for golf in the morning and beer drinking in the evening. Quite a sales call. It also described vacations, foreign language classes, gifts and expensive meals that sales representatives reported providing to increase prescriptions.
In another report quoted in the order, a representative attributed a nearly fourfold sales increase to a VIP client after paying for family vacations and regular family dinners through an employee expense account. It put the recipient, the personal benefit, the reimbursement route and the claimed sales return in the same story.
We see the absurdity in calling that ordinary promotion. In the Commission’s account, the sales organization was explaining the return on buying a doctor’s goodwill while the accounting records presented legitimate business expenses. An insider who knows both descriptions can explain what the ledger leaves out.
The Securities and Exchange Commission alleged that travel companies arranged transportation, lodging and meals for events whose educational purpose was absent or small beside the recreation. The order alleged that, before 2012, the company lacked controls to establish a business purpose, verify that events occurred or adequately check those vendors.
The order’s Japan example makes the proportions hard to miss. An April 2010 seminar about Zadaxin, SciClone’s principal product, appeared to include half a day of education, followed by six days of sightseeing at destinations including Mount Fuji. The order also alleged that, at a separate Hainan gathering, the subsidiary hosted VIP clients for a resort weekend before its annual sales meeting, with no educational component to their stay.
The same account described Chinese healthcare professionals sponsored to attend liver and oncology conferences in the United States. The trips it described included sightseeing in Las Vegas and excursions to Disneyland. For an employee who arranged the itinerary, the allocation of time says something the conference title cannot: how much of the trip served education and how much rewarded the guest.
The alleged benefits also reached officials responsible for product licenses. According to the order, in 2007 SciClone had a new medical-device license application and a renewal for its largest product pending before China’s State Food and Drug Administration. It hired a regulatory affairs specialist to facilitate the licensing.
According to the Commission, the specialist arranged a company-paid trip to an academic conference in Greece for two officials, one overseeing new approvals and the other renewals. The conference concerned only the new device. When the officials could not obtain visas in time, the specialist instead supplied at least $8,600 in lavish gifts and submitted reimbursement requests, the first approved by the subsidiary’s senior vice president.
The substitution is the telling part. In the Commission’s account, a missed conference turned into gifts for the officials who controlled the pending decisions. The promised educational event disappeared, but the proposed benefit survived.
The order said SciClone fired the specialist and investigated that person’s conduct and practices in China. The review did not extend to the wider sales and marketing practices, and the order said neither SciClone nor the subsidiary took further remedial action after that investigation ended in 2008.
SciClone’s books-and-records allegations followed the payments through the subsidiary and into the parent’s financial statements. The Securities and Exchange Commission alleged that improper benefits appeared as sponsorships, travel and entertainment, conferences, honoraria and promotion expenses. It separately alleged that inadequate accounting controls failed to detect and prevent the payments.
The order described a later internal review of employee promotion expenses from 2011 through early 2013. It said the review found fake fapiao, inconsistent amounts or dates, excessive gifts and meals, unverified events, doctored honoraria agreements and duplicate meetings. The Commission alleged that some reimbursed funds supported the sales practices that continued through at least 2012.
Those findings connect the false record to the money it released. The person approving reimbursement might see an event description and supporting paperwork, while the sales representative knew which prescriber the spending was meant to influence. Comparing the approval, the actual event and the sales report brings those separate views together.
Fresenius Medical Care supplies a close parallel in China’s public-health market. The Securities and Exchange Commission alleged in its order that bonus payments to publicly employed healthcare professionals depended partly on treatment volumes or new patients, and that internal emails suggested an effort to influence clinic purchasing decisions. The order also described a manager’s concern about how staff named the payments:
The inaccurate record-keeping can be attributed to a senior FMC China manager, who cautioned a fellow employee in 2011 to avoid the use of the term bonus due to “internal legal compliance” concerns when describing these payments.
In the Matter of Fresenius Medical Care AG & Co. KGaA, SEC order, March 29, 2019
The 2022 Journal of Forensic and Investigative Accounting study Fresenius Medical Care: A Case Study on the FCPA traces those Chinese incentives to payments generally recorded as center marketing fees. It concludes that managers and employees circumvented controls despite flagged transactions and existing policies, sharpening the SciClone question: what did management do with information already moving through the business?
At SciClone, the Commission alleged that representatives openly reported the personal benefits and prescribing results. At Fresenius, it alleged that a manager cautioned against a revealing label. In our reading, one sales team spelled out the payoff while a manager at the other company worried about the label.
The order required SciClone to surrender $9,426,000 in sales profits and pay a $2,500,000 civil penalty. We see the imbalance: the penalty was smaller than the sales profits SciClone had to surrender, yet the company admitted none of the conduct.
The order also recorded SciClone’s review of travel and entertainment reimbursements, reduction in travel and event-planning suppliers, and stronger vendor checks and payment procedures. For someone handling travel or promotion expenses, those changes identify the same points where the alleged payments had passed through unchecked.
The useful whistleblower evidence in this case crosses several desks. Sales reports explain the expected prescription growth, itineraries show the benefit delivered, reimbursement records identify the funding, and approvals show who authorized it. A regulatory employee may instead recognize the connection between a pending license and a gift to the official handling it.
We work with you to connect that knowledge to the company’s decisions and accounts. A sales employee may understand why a particular doctor became a VIP, while a finance or audit employee may know why the supporting documents were questioned. Those perspectives can explain the same payment from different sides of the business.
SciClone’s case was an SEC enforcement action, and whistleblower rewards depend on the program. A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. Our experts work through the reward questions for foreign-bribery information with you based on the conduct and records you know.
If you saw a doctor’s prescription volume drive a travel budget, or a promotion expense conceal a personal benefit, speak with our whistleblower experts about the payments you know. We build the case with you and bring in pharmaceutical bribery whistleblower lawyers who understand public-health purchasing, overseas sales and corporate accounts. We stay beside you as your knowledge of the business becomes the evidence behind the case.