COPD Foundation Commends Congressman Leonard Lance (R-NJ) for Raising Issues Regarding Biomarkers

July 11, 2011

COPD Foundation
Stephanie Clark 
201-641-1911 x53


Washington, D.C. (July 11, 2011)
—The COPD Foundation acknowledges the actions of Rep. Leonard Lance (R-NJ) in posing a key question about biomarkers during the discussion on July 7, 2011 by the U.S. House Energy and Commerce Subcommittee on Health about reauthorization of the Prescription Drug User Fee Act (PDUFA), which expires on September 30, 2012. The subcommittee also reviewed ways to improve the Food and Drug Administration's (FDA) regulatory process. 

Pharmaceutical companies that submit new drug applications pay user fees that account for a significant portion of the FDA’s budget. The COPD Foundation has great interest in PDUFA because a portion of the pharmaceutical company user fees will be designated to help FDA review and qualify biomarkers.

Rep. Lance noted, “Innovative drug development is increasingly dependent on the use of new biomarkers of disease to target the right patients.”

He further posed this question to Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, “…given the importance of biomarkers in drug development and personalized medicine, for both common and rare diseases, is the FDA funding structure adequate to qualify and approve biomarkers?”

Dr. Woodcock responded that the FDA is very excited about biomarkers, that the agency has issued draft guidance on biomarkers, and is actively investigating pharmacogenomics.

The COPD Foundation’s interest in this area stems from the need for new biomarkers of COPD that can be used to guide new therapies. To address this need the Foundation formed the COPD Biomarkers Qualification Consortium, with a mandate to qualify public domain biomarkers that will assist in the development and registration of treatments for COPD with the FDA. The Consortium will achieve this goal through analyzing pooled public and private data and submitting the results to the FDA for review and approval (i.e., qualification).

“This review demands FDA resources at a time when they are focused on meeting the review deadlines for drug product submissions,” says John Walsh, president and CEO of the COPD.  “The draft PDUFA reauthorization legislation proposes to support increased scientific capacity to adequately address the review of submissions proposing new biomarkers. Public and congressional support for the new legislation, as well as agency commitment to its goals, is essential for advancing therapies for COPD and many other diseases.”

Representative Lance’s question calls attention to the importance of this support, and affirms the importance of the FDA’s commitment to biomarker qualification. With FDA-qualified biomarkers aiding their development and use, new therapies for COPD will be able to reach the right patients and reach them sooner.

About COPD
Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death in the U.S. and the only chronic disease growing in mortality. It affects approximately 24 million Americans but only 12 million are diagnosed. COPD includes chronic bronchitis, emphysema, and adult onset (refractory) asthma. Symptoms include breathlessness, wheezing, and chronic coughing. Visit or call 1-866-316-COPD (2673).