Pfizer Inc. will pay more than $60 million to settle charges brought against it by the Securities and Exchange Commission and the U.S. Department of Justice for violations of the Foreign Corrupt Practices Act (FCPA).
In an SEC complaint against Pfizer filed in U.S. District Court for the District of Columbia on Tuesday, the Commission alleges that subsidiaries bribed doctors and health care professionals employed by foreign governments in order to win business and increase sales.
The SEC charges that employees and agents of Pfizer's subsidiaries in Bulgaria, China, Croatia, Czech Republic, Italy, Kazakhstan, Russia, and Serbia made improper payments to foreign officials to obtain regulatory and formulary approvals, sales, and increased prescriptions for the company's products. An effort to conceal the bribes was made by recording these transactions in accounting records as promotional activities, marketing, training, travel and entertainment, clinical trials, and conferences.
The misconduct dates back as far as 2001, the SEC says. In China, for example, Pfizer employees invited “high-prescribing doctors” in the Chinese government to "club-like meetings that included extensive recreational and entertainment activities to reward doctors' past product sales or prescriptions."
Pfizer China also created various “point programs” under which government doctors could accumulate points based on the number of Pfizer prescriptions they wrote. The points were redeemed for various gifts ranging from medical books to cell phones, tea sets, and reading glasses. In Croatia, Pfizer employees created a similar bonus program for doctors employed in senior positions in Croatian government health care institutions. Once a doctor agreed to use Pfizer products, a percentage of the value purchased by a doctor's institution would be funneled back to them in the form of cash or gifts.
The complaint notes that Pfizer made a voluntary disclosure of misconduct by its subsidiaries to the SEC and Department of Justice in October 2004, has fully cooperated with SEC investigators, and “took such extensive remedial actions as undertaking a comprehensive worldwide review of its compliance program.”
The SEC also separately charged Wyeth LLC, a pharmaceutical company Pfizer acquired in 2009, with FCPA violations (both before and after the acquisition). According to the SEC, subsidiaries marketing nutritional products in China, Indonesia, and Pakistan bribed government doctors to recommend their products to patients by making cash payments and gifting them with BlackBerry devices, cell phones, and travel incentives. Fake invoices concealed the the payments.
Following the acquisition, Pfizer undertook a risk-based FCPA due diligence review of Wyeth's global operations and voluntarily reported the findings to the SEC, the complaint notes. It adds that Pfizer “diligently and promptly” integrated Wyeth's legacy operations into its compliance program.
Pfizer and Wyeth agreed to separate settlements which, combined, total more than $45 million. Wyeth also is required to report to the SEC on the status of its remediation and implementation of compliance measures over a two-year period.
In settling the SEC's charges, Pfizer and Wyeth neither admitted nor denied the allegations. The settlements are subject to court approval.
Also on Aug. 7, the Department of Justice (DOJ) announced that Pfizer H.C.P. Corporation, an indirect wholly owned subsidiary of Pfizer Inc., agreed to pay a $15 million penalty to resolve its investigation of FCPA violations.
The settlement says that due to “extensive remediation and improvement of its compliance systems and internal controls, as well as the enhanced compliance undertakings included in the agreement,” Pfizer H.C.P. is not required to retain a corporate monitor, but Pfizer Inc. must periodically report to the on the implementation of its remediation and enhanced compliance efforts.