Armon Comments on Importance of Compliance Guidelines
Bruce D. Armon, a Partner and Chair of the Life Sciences Practice Group, was quoted in this article about the marketing and promoting of drugs for "off label" uses that are not approved by the FDA.
A company must specify the proposed use of a product in both the application to the FDA and on the labeling of the finished product. Although it is legal for doctors to prescribe drugs for off-label uses, pharmaceutical companies are banned from marketing any use of a product the FDA has not approved.
Pharmaceutical companies are finding themselves in court for using false sales practices for antipsychotic and other drugs. According to one Pennsylvania lawsuit, doctors were manipulated into prescribing antipsychotic medications for non-approved uses, such as general mood disorders and attention deficit disorder. The same complaint also says that many state Medicaid and Program of All Inclusive Care for the Elderly (PACE) participants who took these medications suffered serious side effects, such as diabetes, stroke and substantial weight gain.
"General counsel need to continue to ensure that the compliance obligations are understood by everyone in the organization," Mr. Armon said. "Compliance activities and procedures must remain part and parcel of the company's everyday operations."