The U.S. Food and Drug Administration (FDA) announced it will hold a public meeting with the healthcare industry, including pharmaceutical and medical device companies, doctors, patients, research institutions, healthcare organizations, and payors and insurers to discuss regulation on manufacturers’ communications regarding off label uses of drugs and medical devices.
Under current regulations, physicians are allowed to prescribe medications or utilize medical devices for uses other than what they have been approved for by the FDA, called off-label uses. Drug and device manufacturers are not allowed to promote or market their products for off-label use.
Unfortunately, current regulations fall quite short in protecting consumers. Earlier this summer, two Johnson & Johnson (J&J) executives were found guilty of ten counts of illegal marketing of the Relieva Stratus Microflow Spacer. Shortly thereafter, the company agreed to pay $18 million to settle claims levied by the U.S. Department of Justice alleging the company illegally marketed the Microflow Spacer for uses not approved by the FDA.
But this is nowhere near the most expensive payout settling allegations of illegal marketing. In 2012, pharmaceutical giant GlaxoSmithKline (GSK) agreed to pay a massive $3 billion to resolve illegal marketing claims. Among the medications GSK illegally promoted was anti-nausea drug Zofran.
Originally approved to treat nausea and vomiting in chemotherapy and surgery patients, Zofran became a popular off-label treatment for morning sickness. Now more than 300 families allege Zofran taken during pregnancy caused their children to suffer from severe side effects.
Updated regulations on off-label communications could help prevent dangerous unapproved uses of drugs and medical devices. Consumer advocates also hope stronger regulations would impose harsher consequences for manufacturers. The hearing is scheduled to take place this November and will hopefully provide the FDA with valuable advice for better regulations.