FDA under pressure to clarify off-label rules

The US Food and Drug Administration is coming under increasing pressure from other government authorities to review and provide clarity on off-label promotion regulations, as recent settlement agreements with pharmaceutical companies appear to give these companies license to extend previous working definitions of “scientific exchange” as allowed by law, notes Dr Nicola Davies in her monthly exclusive FDA Blog for The Pharma Letter.

Current regulations state that doctors are permitted some discretion to prescribe drugs to patients outside of the stated ‘label’ purpose, use, or dosage. In other words, to prescribe them outside of the use approved by the FDA. However, drug companies are not permitted to advertise or promote their drugs for off-label uses or benefits, even if these are being regularly prescribed off-label by doctors, and yielding good results for patients.

Increasing numbers of settlement agreements under this law are highlighting growing challenges for the FDA in balancing the joint aims of ensuring safe and regulated drug use, allowing fair competition and productivity in the industry, and optimizing the available treatments for patients. The settlements are raising questions about whether the current rules are fit for purpose. However, it is unclear whether a relaxing of the law or a more stringent approach is best suited to the FDA’s aims and, ultimately, in the best interests of patients.