August/September 2013

FDA to Hold Second Annual Patient Network Meeting 

The FDA’s Patient Network will be holding its annual meeting on September 10, 2013, serving as a forum for FDA’s patient stakeholders and the general public, including health professionals, academia, and industry to learn about regulatory issues related to drug development, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to incorporating meaningful patient input that will represent broad patient perspectives in medical product development and regulatory decision-making. Specifically, this meeting will provide information and facilitate a discussion about: drug development and regulatory standards, clinical trial design, new regulatory tools for improving premarket drug regulation, and industry-FDA-patient collaboration for innovative drug development.

Some notable senior FDA officials speaking at the meeting include Richard Moscicki, MD, the Deputy Center Director for Science Operations at the Center for Drug Evaluation and Research (CDER), Lynne Yao, MD, the Acting Associate Director in the Office of New Drugs in CDER, Cathy Miller, MPH, BSN, the Commander of the US Public Health Services within the Office of Health and Constituent Affairs, and Robert Temple, MD, the Deputy Director for Clinical Science at CDER.

The meeting will be held at the Washington Marriott at Metro Center from 8:30 a.m. to 4:30 p.m. To access the webcast, participants must register in advance. There is no cost to attend the meeting; however individuals are responsible for any costs associated with meals and their transportation.

ACT-AD Sends Letters of Support for Bipartisan Bills Protecting FDA User Fees from Sequester

ACT-AD recently sent letters to the leadership of the House and Senate Budget Committees urging prompt consideration of H.R. 2725, the Food and Drug Administration Safety Over Sequestration Act of 2013, and S. 1413, the FDA User Fee Protection Act, legislation to protect FDA user fees from sequestration.

The letters convey the importance of the user fee program in funding timely and predictable drug, device, and biologic review activities so that new interventions can be made available to patients. It also describes how the FDA has been trying to maintain their direct review activities and pursue many of the exciting new initiatives included in the most recent PDUFA and MDUFA authorizations, without collecting the full fees planned for this year. Sacrifices have been made at FDA to move forward with these new initiatives relying only on FY 2011 funding levels, and even in the complete absence of funds in some cases. Such set-backs are dealing a devastating blow to its ability to implement enhancements, recruit top talent, bring treatments to those in need, and will not bode well for the agency in the future.

ACT-AD Chair, Daniel Perry, encourages congressional leaders to approve the user fee protection bills, exempt FDA user fees from the sequester, and allow the agency to begin restoring its ability to meet the needs of all of the stakeholders it serves, particularly those patients who live with the devastation of Alzheimer’s disease and are in need of improved treatment options.

To read the full bills, click here for the House version, or here for the Senate version.

To read the ACT-AD letters of support, click here for the House letter, or here for the Senate letter.

ACT-AD Member to Host 14th Annual International Conference on Alzheimer’s Drug Discovery

The Alzheimer’s Drug Discovery Foundation (ADDF) will be hosting the 14th International Conference on Alzheimer’s Drug Discovery on September 9-10, 2013 in Jersey City, N.J. The annual ADDF conference brings together academic and industry scientists intent on accelerating the development of innovative treatments for Alzheimer’s disease and related dementias.

The ADDF’s funded investigators and top level scientists in the field will present on their current research progress and stimulate discussion. The conference offers ample opportunities for collaboration and partnering. Guests will include over 150 key stakeholders from the pharmaceutical, biotechnology, government, and academic communities. ACT-AD and the Alliance for Aging Research are media partners for the event.

For more on the conference, click here.