March 2012

PDUFA V Reauthorization Update

The fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V) is entering the next stage of congressional consideration. The House Energy and Commerce Committee held multiple hearings on the proposed user fee agreement negotiated by the U.S. Food and Drug Administration (FDA) and the pharmaceutical, biotech, and medical device industries. The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on the user fee agreements on March 29, 2012. The committees of jurisdiction aim to mark up their respective proposals by the end of April and complete the entire process before the August recess.

The Senate HELP Committee began releasing a series of discussion drafts of the proposed legislation for public comment. The first draft, released on March 16, deals with the Medical Device User Fee Program reauthorization. Comments are being received until April 1. The committee plans to release additional discussion drafts in the coming weeks.

To view the first Senate discussion draft, click here.

ACT-AD Supports Increase in FDA Appropriations

This month the ACT-AD Chair sent a pair of letters to the leadership of the House and Senate Appropriations Subcommittees on Agriculture, Rural Development, FDA, and Related Agencies in support of increased appropriations for the U.S. Food and Drug Administration (FDA) The letters also reaffirmed ACT-AD’s mission to partner with the FDA to expedite the development, review, and approval of transformational therapies for Alzheimer’s disease, but urged the need to adequately support the agency.

The letters state that while committed to an active partnership with the FDA, the agency needs sufficient funding to achieve our shared goals and for that reason the Coalition supports the inclusion of $2.656 billion for FDA in their FY 2013 appropriations bills. This level of funding is also recommended by both the Alliance for a Stronger FDA and Leaders Engaged on Alzheimer’s Disease.

To view the House letter, click here.

To view the Senate letter, click here.

ACT-AD Chair Speaks to BioCentury This Week About Alzheimer’s Funding and Biomarkers

On March 18, Daniel Perry, ACT-AD’s Chair, was interviewed by BioCentury This Week to share his thoughts on U.S. funding of Alzheimer’s research and the use of biomarkers to speed Alzheimer’s therapy development. During the interview, Perry commends the Obama Administration for repurposing and committing additional funds for Alzheimer’s research, but says additional steps must be taken to help speed the delivery of better treatments and cures to those in need.

Perry also called for the FDA to more rapidly adopt the use of biomarkers and other tools to detect and treat Alzheimer’s disease earlier and more effectively. He states that the key to bringing disease-modifying therapies to market in the near future will be the use of biomarkers as surrogate endpoints to more accurately test new therapies. The ability to test, and seek approval for, new therapies on the biological mechanisms behind the disease would greatly speed their development and delivery to those suffering from the disease.

Perry finished by pointing out that the scientific community is advancing emerging consensus around those sophisticated tests that would serve to speed diagnosis of the disease, and the development of new therapies.

To view the edition of Neurobiology of Aging, click here.

To view Perry’s interview click here.