Monday, January 26, 2009

Make your opinions count: FDA Request for Public Comment

The Food and Drug Administration (FDA) is seeking information and comments on issues related to the enrollment of certain populations in clinical drug trials. Particularly, the FDA is requesting information and comments from medical product manufacturers, institutional review boards (IRBs), patient groups, universities, researchers, community groups, and other interested parties.

The request is the result of the FDA Amendments Act of 2007. The FDA will take the information from the public comment period, and other information they’ve collected, to send to Congress in a required report in the Fall of 2009. The report will address the best practice approaches on increasing the participation of elderly populations, children, racially and ethnically diverse communities, and medically underserved populations in clinical drug trials. FDA requests that those with information on possible approaches to increase participation of these groups in clinical drug trials submit comments.

This is of particular importance in light of the clinical trials that recently validated the use of BiDil as a treatment for Congestive Heart Failure in African Americans. 

It had long been known that African Americans with congestive heart failure (CHF) responded less effectively to conventional CHF treatments (particularly ACE inhibitors) than Caucasians. BiDil, which is a combination of hydralazine (an antihypertensive) and isosorbide dinitrate (a vasodilator), was originally rejected by the Food and Drug Administration (FDA) in 1997. But a subsequent clinical study in 2005 demonstrated that BiDIL actually reduced mortality by 43%, reduced hospitalizations by 39%, and quality of life markers in African American patients with CHF. The BiDil combination preparation was then approved by the FDA in June 2005 for African American use only based on the results of that study. It is the first race-based prescription drug in the United States.

DATES: Submit written or electronic comments by February 27, 2009.

The full text of the Federal Register notice and the instructions for electronic submission of comments is available HERE.

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