US Regulators may ask CEO to certify Compliance

Compliance with the so called Food, Drug and Cosmetic Act is at top priority for the Department of Justice in the US. This statement has been given by Assistant Attorney General Stuart F. Delery in a conference on January 29, 2014 in Washington.

Since 2009 judgments and settlements under the False Claims Act (FCA) and the Food Drug and Cosmetic Act (FDCA) had totaled over $ 20 billion. This is an enormous amount of money. The current case against Ranbaxy resulted in a $ 500 million resolution, the largest drug safety settlement ever with a generic drug manufacturer. In addition to the settlement Ranbaxy had to hire external auditors. These auditors identified that the company badly needed cGMP training. However, this training never happened. This has caused continuous GMP deviations over a long time even after the first GMP findings were identified by FDA Inspectors. Internal procedures and policies alone are therefore not enough.

This leads the US Department of Justice to not only focus on monetary measures. Non-monetary measures are also of great importance. Mr. Delery mentioned that the US department of justice will also encourage a culture of compliance in the company by supporting individuals and companies to disclose unlawful conduct and fraud.

When it comes to compliance the Office of the Inspector General of the Department of Health and Human Services not only agreed on a 1,5 billion criminal and civil resolution in 2012 with Abbott Laboratories relating to its epilepsy drug. It also made the senior management  responsible for the company's future compliance efforts. Although the issue was not related to GMP problems the action can be applied to any other area of non-compliance. The resolution imposed a term of probation for five years which requires the company to report any probable violations of the FDCA and requires the CEO personally to certify compliance with the reporting requirements. It also contains a corporate integrity agreement that requires, among other things, the board of directors to review the efficacy of the company's compliance effort.

In Europe law makers and regulators will also have to think about measures to improve compliance with the legislation. Although the legal system is different to the one in the US some laws in other areas already contain requirements which will allow to make senior management responsible for compliance. For example the environment protection laws in many European countries include such an element. For instance, the law in Germany (the so called Federal Immission Control Act)  does not only contain penalties against the responsible person for environmental protection it also contains the requirement to name a management representative in the board of directors.


Keynote Address at the CBI Pharmaceutical Compliance Congress

RAPS Article DOJ Says Corporate Integrity Agreements Are Cornerstone of New Compliance Approach

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