An internal investigation and voluntary disclosure by Pfizer led to a settlement with the US Department of Justice and Securities and Exchange Commission.
Pfizer has resolved with the US Department of Justice (DOJ) and Securities and Exchange Commission (SEC) matters related to certain improper payments in the operations of two of its subsidiaries outside the United States.
A Pfizer subsidiary (Pfizer H.C.P. Corporation) will enter into a deferred prosecution agreement with the DOJ and pay a fine of $15 million. Under the terms of a civil settlement with the SEC, Pfizer agreed to a disgorgement of profits of $16 million and prejudgment interest of $10.3 million. The DOJ declined to bring a criminal action against Pfizer. The DOJ settlement with Pfizer H.C.P. Corporation covers improper conduct in Bulgaria, Croatia, Kazakhstan, and Russia. The Pfizer SEC civil settlement covers improper conduct in all of these countries as well as in Italy, China, the Czech Republic, and Serbia. As part of its agreement with the DOJ, Pfizer H.C.P. Corporation will continue to cooperate with the DOJ for a period of two years in connection with its settlement.
In a separate civil settlement with the SEC, Pfizer’s Wyeth subsidiary has agreed to a disgorgement of profits of $17.2 million and prejudgment interest of $1.66 million to resolve issues involving certain improper payments in the operations of four subsidiaries outside the US. Pfizer conducted a risk-based Foreign Corrupt Practices Act due-diligence review of Wyeth’s global operations after it acquired the company in late 2009, and voluntarily disclosed these issues to the US government, according to an Aug. 7, 2012, Pfizer press release. Pfizer’s postacquisition due diligence review of Wyeth identified certain improper payments in China, Saudi Arabia, Indonesia, and Pakistan.
“There is no allegation by either DOJ or SEC that anyone at Pfizer’s or Wyeth’s corporate headquarters knew of or approved the conduct at issue before Pfizer took appropriate action to investigate and report it, “ said Pfizer in its release. “As soon as these local activities came to the attention of Pfizer’s corporate headquarters, they were voluntarily brought to the attention of the DOJ and SEC. Today’s settlements are focused solely on these local activities.”
All the conduct at issue was investigated by Pfizer and voluntarily disclosed to the US government, according to the company. Pfizer began self-reporting to the US government in 2004 after the discovery of certain improper payments that had been made by employees of a recently acquired Pfizer affiliate in Croatia. Pfizer legal and compliance staff, outside counsel and auditors, conducted an internal investigation and regularly briefed DOJ and SEC on its findings, said Pfizer in its release.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.