Nov. 28, 2012 >> back to issue

PH Patient Testifies Before the FDA to Make Our Voices Heard in the Drug Review Process

Colleen Brunetti testifies with the FDA

Thanks to a new law, the Food and Drug Administration (FDA) will expand the way it gathers patient input during its review and approval of drugs and devices. The FDA plans to select 20 specific disease communities to focus on in 2013. As a first step, they took testimony in October from representatives of more than 50 disease communities. FDA nominated PAH as part of this group. 

PH patient and PHA Board Member, Colleen Brunetti, travelled to Washington to speak to an FDA panel, arguing for the inclusion of both PAH and organ transplant in the pilot year of FDA’s new initiative. 

PHA’s president Rino Aldrighetti submitted written comments, as well as letters of support from several of PHA’s partner organizations encouraging the FDA to include both PAH and organ transplant in the program’s first year. 

The goal of the patient-focused initiative is to help the FDA understand how its approval processes can better meet patients’ needs. For example, the FDA will seek input on the way it assesses risk versus benefit during the approval process for new drugs and devices. After working with 20 disease communities in the program’s first year, the FDA will expand the program in the future. 

We will continue to work closely with the FDA through this and other initiatives to improve the drug and device approval process for the PH community. Stay tuned for updates on our progress!

 

FacebookGoogle +TwitterLinkedInPinterestInstagramYouTubeBloggerFeedsPHAware Download our App

The information provided on the PHA website is provided for general information only. It is not intended as legal, medical or other professional advice, and should not be relied upon as a substitute for consultations with qualified professionals who are familiar with your individual needs.

801 Roeder Road, Ste. 1000, Silver Spring, MD 20910   Patient-to-Patient Support Line: 1-800-748-7274
Webmaster@PHAssociation.org
    Privacy Policy   Virtual Tour of Website    Provide Feedback & Report Bugs

Designed by Matrix Group International, Inc.® | © 2014 Pulmonary Hypertension Association. All Rights Reserved.

NORD

The National Organization for Rare Disorders (NORD) awarded PHA the Abbey S. Meyers Leadership Award in 2012 for outstanding service to PHA members in advocacy, education and other key areas.