Industry Medical Affairs: Be Careful What And How You Communicate
by John Cullen, Ph.D., J.D.

Among the many rules in the Code of Federal Regulations (“CFR”) that regulate communications between the pharmaceutical industry and the public is one found at 21 CFR 312.7.  Interestingly, this under-appreciated regulation, which permits communication on a wide range of therapeutic subjects including marketed products and unapproved uses between industry medical and scientific professionals and their colleagues in the medicinal and scientific communities, is found among regulations dealing with investigational drugs.   The regulation reads:

“A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media.”

Under this regulation, industry scientists and medical personnel may present the results of clinical research on both marketed and investigational drugs, respond to inquiries from healthcare professionals, and generally provide a wide spectrum of information on products and therapeutic subjects, including information on unapproved uses.

Such communications, when done in a balanced, objective and non-promotional manner, are not considered false and misleading under the labeling provisions of the Federal Food, Drug & Cosmetic Act (the “Act”).  In fact, the FDA supports the dissemination of useful scientific and medical information about products regulated under the Act. 

However, this activity must be managed very carefully, because the line between dissemination of fair and balanced scientific information and promotion of unapproved uses is not always clear in this era of the internet and other technological advances in communication media. 

Over the past few years, the industry’s use of medical correspondence, press releases, Speakers Bureaus and Advisory Boards have become the focus of investigation by both FDA and the HHS Office of Inspector General (“OIG”) relating to promotion of off-label uses of drugs and devices.   Some of these cases have resulted in criminal charges being brought not only under the Federal Food, Drug & Cosmetic Act, but also the Federal False Claims Act and the Medicaid/Medicare “Anti-Kickback” statute.  Recent examples include Pfizer Inc. (“Neurontin”), Serono Laboratories, Inc. (“Serostim”), and InterMune Inc. (“Actimune”) among others. 

The above are extreme examples of what can happen if companies actively engage in promoting off-label use, but what is interesting about these cases is the intense scrutiny by the government into not only commercial activities, but also the activities of the Medical Affairs function of these companies. 

Among the areas of interest were the medical communications function (including the nature and content of responses to unsolicited queries from the medical community), the use of outside speakers, and use of clinical grants.   In some of these cases, the content of medical correspondence and expert speaker presentations, as well as educational and clinical grant activities of the Medical departments, were so closely aligned with the objectives of marketing and sales departments in the promotion of off-label drug use that the government argued that the Medical function was just another part of the illicit enterprise. 

The government’s pursuit of these cases is based on the legal theory that if companies engage in activities that promote off-label uses of their products, the resultant claims filed under federal (and state) reimbursement programs are fraudulent.  Further, activities that cause the filing of these fraudulent claims are also in violation of federal law including, but not limited to, the statutes referred to previously.

This does not mean physicians are prohibited from prescribing drugs for unapproved indications because federal laws do not regulate the practice of medicine.  Companies are specifically prohibited from engaging in activities that promote such prescribing, including activities that are ostensibly carried out under 21 CFR 312.7.

Another interesting facet of these cases is that each began as a “Qui Tam” (“Whistleblower”) case filed by former employees including, in at least one case, medical department employees.   Each of the cases were settled by the payment of huge fines (Pfizer: $500 M, Serono: $800 M, InterMune: $39 M), Consent Decrees and Corporate Integrity Agreements.  These extraordinary fines represent not only punishment for illegal activities, but also a so-called “disgorgement” of profits derived from these activities. 

In this time of increased scrutiny by the government, it is well advised that companies carefully examine the functions within the Medical Affairs -- particularly medical communications activities -- to ensure understanding and strict compliance with 21 CFR 312.7 and other regulations governing their activities.