FDA ISSUES DRAFT GUIDANCE ON OFF-LABEL DRUG USE

Pharmacy Times, Volume 0, 0

The FDA has issued draft recommendationsallowing drug and medical device manufacturersto distribute reprints of peer-reviewedresearch from reputable medical journals onunapproved uses for their products, with the stipulation that thematerial not be written, edited, or otherwise influenced by manufacturersor individuals with financial ties to them.

In its draft guidance, the FDA notes that "off-label uses or treatmentregimens may be important and may even constitute a medicallyrecognized standard of care." The FDA's Good Reprint Practicesare being provided, "in recognition of the public health value to healthcare professionals of receiving truthful scientific and medical information,"according to the document.

In a letter to FDA Commissioner Andrew von Eschenbach, MD,Rep Henry Waxman (D, CA), chairman of the House Committee onOversight and Government Reform, called the guidance "ill-advised"and urged that the FDA not move forward with it, pending the committee'sown inquiry into the draft guidance and the process that ledto its development.

The FDA's guidance documents, including this draft guidance,describe its current thinking on a topic and should be viewed only asrecommendations, according to the agency. It can be accessed atoversight.house.gov.