More News on the Coming Wave of FDA Enforcement Actions

Oct 15, 2010   

Yesterday we reported the comments of Eric Blumberg, FDA Deputy Chief Counsel for Litigation, who said that the FDA will increase misdemeanor criminal prosecutions for pharmaceutical executives whose companies are promoting off-label uses of their products. At this same conference, sponsored by the Food and Drug Law Institute, additional guidance was provided for the pharma industry with respect to coming trends in FDA enforcement and how companies can achieve compliance now.

In addition to prosecuting off-label marketing of pharmaceutical products, Blumberg also warned that criminal investigations will increase and be focused on the distribution of unapproved new drugs as well as the failure to report unexpected adverse events caused by these products.

Eugene Thirolf, Director of the Office of Consumer Litigation at the Department of Justice (the FDAs government prosecutor), echoed Blumbergs comments stating that he foresees more criminal prosecutions arising from safety issues related to pharmaceutical products; e.g., distribution of defective products, adverse event reporting failures and fraudulent use or reporting of testing data.

This increased emphasis on criminal investigations and prosecutions by the FDA and the Justice Department are not just confined to consumer issues, however. Blumberg, Thirolf and several other speakers also discussed holding pharma companies accountable for regulatory issues arising from manufacturing. Company executives were admonished to adhere to current Good Manufacturing Practice (cGMP) regulations and standards, and cautioned not to ignore (or cover-up) safety issues discovered in the manufacturing and testing of pharmaceutical products. Thirolf stated that criminal prosecutions could arise from false documentation of manufacturing processes and procedures.

Much of the impetus for these new investigations and prosecutions will come from the FDAs Office of Criminal Investigations, which the agency has pledged to revamp and refocus.

The message from the FDA is clear “ not only for pharmaceutical companies, but for dietary supplement companies, medical device manufacturers, food producers, cosmetic companies and other FDA regulated industries as well:

Now is the time to proactively implement FDA compliance programs, to perform audits of your existing compliance programs, and to review your manufacturing processes, distribution networks, advertising, websites, and promotional activities to ensure compliance with FDA laws and regulations. Failure to do so now will result in even greater problems “ including criminal investigations and prosecutions “ later.