June 2010

FDA Continues Stakeholder Outreach on PDUFA Reauthorization

In April of 2010, the U.S. Food and Drug Administration (FDA) took the first step in engaging the broader patient and stakeholder community in discussions surrounding the reauthorization of the Prescription Drug User Fee Act (PDUFA). At the April 12 public meeting, representatives of patient, consumer, provider and industry groups presented on the important role that the user fee program plays in the review of new interventions. These presentations captured the diverse views of the many stakeholders whose interests and constituencies will be affected by modifications to the user fee program. The current PDUFA cycle is set to expire in September of 2012.

As a second step in broadening engagement in the PDUFA reauthorization process, FDA released a notice earlier this month requesting that stakeholder groups express their desire to continue participation in periodic meetings with FDA staff.   This call was open to patient and consumer advocacy groups, health professionals, and scientific and academic experts. These meetings will begin as early as July 1, 2010 and will continue as FDA negotiates with regulated industry.  The final FDA and industry agreement will be transmitted to Capitol Hill for Congressional action prior to expiration of current authority to collect fees under PDUFA IV.

To view the complete Federal Register notice, click here.

Public–Private Partnership Launches New Clinical Trial Database

The Coalition Against Major Diseases (CAMD) launched a new, combined clinical trial database on June 11.   At a press conference in Washington, D.C., CAMD publicly announced the release of the database that contains unidentified information for more than 4,000 Alzheimer’s disease patients who have participated in 11 industry-sponsored clinical trials. This database is designed to be openly shared by pharmaceutical companies and will be made available to qualified researchers around the world. It is the first of its kind for the Alzheimer’s community, and represents a large step forward in combining efforts to develop more effective treatments and potential cures for Alzheimer’s disease. Dr. Joshua Sharfstein, FDA’s Principal Deputy Commissioner, participated in the press conference, and reiterated the Agency’s commitment to regulatory science collaborations that can speed safe and effective treatments to the public.

CAMD’s database will help to empower researchers to more accurately predict the course of Alzheimer’s disease.  It is expected to have applications for understanding the pathology of Parkinson’s,Huntington’s, and other neuro-degenerative diseases  as well.  The end goal of such an undertaking is to enhance the ability of scientists to design more efficient clinical trials that have greater chances of demonstrating the safety and effectiveness of new treatments.

CAMD is supported in part by ACT-AD members the Alliance for Aging Research and the Alzheimer’s Foundation of America.