FDA Worries About Off-Label Use, Stewardship With Limited-Population Approval Pathway

Article preview from “The Pink Sheet”-  February 11 , 2013

FDA asks groups how it can help ensure prescribing is limited for products approved under proposed new pathway, but several say, other than labeling, it may be out of the agency’s hands.

 FDA Worries About Off-Label Use, Stewardship With Limited-Population Approval Pathway

Article preview from “The Pink Sheet”-  February 11 , 2013

If FDA adds a new pathway for approvals of drugs for small or limited populations, it likely will need considerable help in policing the use of the products, if sufficient controls are even possible.

Antibiotics and other products that have been proposed as candidates for the new pathway would be granted marketing approval based on evidence of safety and effectiveness for a small, specific group of patients with a more serious disease course.

An issue, especially with antibiotics, is the concern that physicians would prescribe the limited population products for patients not intended to receive them. While FDA writes the drugs’ labels, it cannot force physicians and other prescribers to use the drugs as intended. The agency has no control over the practice of medicine.

Off-label use, as well as stewardship in the case of antibiotics, were among the most popular issues stakeholders and FDA discussed during a Feb. 4 public hearing on the limited-population approval pathway.

Agency officials seemed very interested in how it can limit prescribing to the small populations that would be the target of drugs that move through the proposed pathway.

Read the rest of this article now by purchasing it as a PDF.

Leave a Reply

Your email address will not be published. Required fields are marked *