On November 9, 2010, federal prosecutors indicted a retired associate general counsel of GlaxoSmithKline on criminal charges of obstruction and making false statements in connection with a Food and Drug Administration (FDA) investigation into alleged "off-label" promotion of a prescription drug product. The indictment has raised alarm within the pharmaceutical industry and has been widely covered by national media.

In an exclusive interview with BNA's Pharmaceutical Law and Industry Report, James Czaban, the chair of Wiley Rein's FDA Practice opined on how the case may play out, and on some of the ramifications of the government's aggressive new criminal enforcement initiative to target individuals for prosecution in connection with FDA investigations of violations of the federal Food, Drug, and Cosmetic Act (FDCA).

In the indictment, and in a Department of Justice press release, prosecutors allege that the attorney falsely denied that the company was promoting the drug for those purposes and did not hand over materials requested by the FDA. The BNA article noted that the defendant's attorneys issued a statement claiming that "Everything she did in this case was consistent with ethical lawyering and the advice provided to her by a nationally prominent law firm retained by her employer specifically because of its experience in working with the FDA."

Predicting how the case might play out, Mr. Czaban noted that "the case appears to be setting up as a battle of semantics" involving the term "promotional." Mr. Czaban noted that the alleged off-label activities may have been considered to be a type of Continuing Medical Education (CME) which both drug companies and FDA typically consider not to be "promotional" activities, and as such "when [the attorney] told FDA that the company had not developed, devised, established, or maintained any program or activity to promote or encourage [off-label] use of the drug...and that the company's promotional material and activities for the drug are consistent with the approved prescribing information and the supporting clinical data, she may have been 'completely accurate using the nomenclature common to the industry.'" The government "appears to be trying to use a much broader definition of 'promote' and 'promotional' in order to paint her as having given false statements," Mr. Czaban continued.

Other aspects of the government's indictment also appear to be based on disputed definitions. For example, Mr. Czaban noted, the indictment alleges that the attorney falsely told FDA that the company had only two types of advisory boards, when she knew that the company also had another type of board called a Special Issue Board. Mr. Czaban observed that "the government is basing this charge on redefining the 'Special Issue Boards' as 'Advisory Boards' when that is not apparently a term used by the company." Thus, for many aspects of this case, Mr. Czaban added, "I would expect a battle over the definitions of arguably vague words, and in a criminal case, such battles should typically fall in favor of the defendant."

Mr. Czaban noted other potential ramifications of this case. For example, given that the government apparently knew that the responses to FDA's investigation were based on the advice of outside counsel, "it is troubling that this [prosecution] could have the effect of chilling the ability of outside FDA counsel to meet their ethical obligation to zealously represent their clients in these types of matters." He added that the job for FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC)—the arm of the FDA that investigates drug advertising—"just got a lot harder because this case will make any company think twice or three times before voluntarily cooperating with information requests that are not squarely mandated by law." This case will be closely watched by the pharmaceutical industry, and in-house lawyers and employees will certainly take a hard look at any communications with the FDA going forward.

FDA has in recent months made several high profile pronouncements that it will seek to increase its prosecution of individuals for their company’s alleged violations of the FDCA. Under the Responsible Corporate Officer Doctrine (also known as the "Park Doctrine") individuals can be held strictly liable for FDCA violations and punished by up to one year imprisonment and substantial monetary fines even where the individual was not directly involved in and had no direct knowledge of, the violative activities. Moreover, persons convicted of FDCA violations can be excluded (debarred) from working for companies that participate in federal health care programs—i.e., any pharmaceutical company—again without any evidence that they knew of or participated in the violation. While the prosecution in this case is not itself a Park Doctrine issue (the defendant was personally involved in the alleged illegal activity, and the charges do not arise directly out of the FDCA), combined with FDA’s Park Doctrine pronouncements this case serves as a jolting wake-up call to companies and individual employees.

Risk management in this area is ever more important in light of these developments. Wiley Rein's FDA and White Collar Defense practices regularly team up to counsel FDA-regulated companies on developing FDA compliance programs to reduce the risk of future enforcement actions. And, when things do go wrong, our team has extensive experience in handling FDA investigations and the defense of companies and individuals prosecuted under the FDCA.