Bracewell & Giuliani

Foresight is 20/20: The Need For Pharmaceutical Companies to Implement Robust Anti-Corruption Programs


The Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) have ramped up their prosecution of corporations and officers for violations of the Foreign Corrupt Practices Act (FCPA). From 2010 to 2013, the DOJ and the SEC brought a combined 172 FCPA-related actions, for an average of 43 each year. There has been an added focus on pharmaceutical and medical device companies, resulting in significant FCPA settlements like those of Johnson & Johnson in 2011, Smith & Nephew and Biomet in 2012, and Stryker in 2013. Many more companies have either disclosed or are reportedly involved in ongoing FCPA investigations, including AstraZeneca, Bristol-Myers Squibb, Cubist Pharmaceuticals, Eli Lilly, GlaxoSmithKline, Grifols SA, Merck, Nordion, Novartis AG, Sanfoni SA, Sciclone Pharmaceuticals, and Teva Pharmaceutical.
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In The Headlines

Sparta Systems, Inc.

EQMS: An Rx for Ensuring Quality in Over-the-Counter Drugs


The pharmaceutical industry faces complex challenges resulting from regulatory scrutiny, mergers and acquisitions, and a myriad of cost-cutting requirements. Like all pharmaceutical manufacturers, nonprescription drug makers – whose products are readily available over-the-counter (OTC) by most consumers – have a responsibility to ensure the drugs being stocked on store shelves are safe, effective and properly labeled.
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Topic of Discussion

Revitas_Fb

8 Checkpoints for Managing Government Pricing During Mergers & Acquisitions


The pharmaceutical industry is going through a period of unprecedented merger and acquisition (M&A) activity. While pharmaceutical companies must remain focused on the big picture, they also must manage the specific details of M&As — including a wave of legal, financial, and strategic alignment issues and the required due diligence needed to identify and resolve compliance risks related to government pricing (GP).
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