December 2013


Congressional Budget Deal to Ease Strain on FDA

On December 10, House Budget Committee Chairman Paul Ryan (R-WI) and Senate Budget Committee Chair Patty Murray (D-WA) reached an agreement on a proposed budget that would begin to restore funding to federal programs that had been hit hard by this year’s sequester. The proposed budget would also avoid another government shutdown in January 2014. On December 12, the House passed the proposed bill, and it now goes to the Senate for a vote before the end of the year.

The agreement, The Bipartisan Budget Act of 2013, would set current fiscal year discretionary spending at $1.012 trillion increasing to $1.014 trillion the following year, about halfway between the Senate’s proposed $1.058 trillion and the House’s $967 billion. The proposed $63 billion in sequester relief over the next two years is split equally between defense and nondefense programs. In FY 2014, which began October 1, defense discretionary spending would be capped at $520.5 billion with nondefense discretionary spending at $491.8 billion. Health-related federal agencies and programs fall in this nondefense discretionary category.

The proposal provides two years of sequester relief that will free up the fees Food and Drug Administration’s (FDA) collects from industry to review new medical products. Under the sequester cuts which began in March, the Agency has already been denied $2.9 million of those user fees. With a proposed budget of $4.7 billion, and these fees restored in full for at least two years, the FDA should be able to carry out their regulatory tasks at the pace agreed upon in the most recent user fee authorizations, and ensure breakthrough technologies get to patients in need.

For a summary of the proposal, click here, and the full text, click here.

NIH Deposits First Batch of Genomic Data for Alzheimer’s Disease Database

The National Institutes of Health (NIH) announced this month, that it has deposited the first batch of whole-genome sequencing (WGS) data from the Alzheimer’s Disease Sequencing Project (ADSP) into the Database of Genotype and Phenotypes and the Genetics of Alzheimer’s Disease Data Storage Site for free research access. The ADSP is one of the first projects undertaken under the National Plan to Address Alzheimer’s Disease, an intensified national program of research to prevent or effectively treat Alzheimer’s disease.

The initial release includes data from 410 individuals in 89 families. Researchers deposited completed WGS data on 61 families and have deposited WGS data on parts of the remaining 28 families, to be completed soon. WGS determines the order of all 3 billion letters in an individual’s genome, and should provide, “a powerful crowdsourced way to find genomic changes that put us at increased risk for this devastating disease,” according to NIH Director Dr. Francis Collins.

To carry out the ADSP, two NIH institutes — the National Human Genome Research Institute (NHGRI) and the National Institute on Aging (NIA) — formed a collaboration to manage patient samples and genome sequencing. NHGRI has devoted $25 million in sequencing capacity at its three flagship centers: The Genome Institute at the Washington University School of Medicine in St. Louis; the Human Genome Sequencing Center at the Baylor College of Medicine in Houston; and the Eli and Edythe L. Broad Institute of Harvard and MIT, Cambridge, MA.

The sequenced data can be access by visiting the database of Genotypes and Phenotypes (dbGaP) here, or via the National Institute on Aging Genetics of Alzheimer’s Disease Data Storage Site (NIAGADS) here.

For more information on the project, click here.

ACT-AD Advisory Council Members Hold Caregiver Conference on National Alzheimer’s Plan

The Alzheimer’s Foundation of America (AFA) and the National Alliance for Caregiving (NAC) hosted a conference and webcast this month on how to implement caregiver provisions in the National Plan to Address Alzheimer’s Disease at the state and local level. The conference was supported by ACT-AD chair the Alliance for Aging Research and ACT-AD industry sponsor Eli Lilly.“From Plan to Practice: Implementing NAPA in Your State,” attended by over 250 registrants, featured federal and state policy makers who have developed comprehensive plans to provide support and services to people with Alzheimer’s disease and their family caregivers. Federal officials including Acting Assistant Secretary for Planning and Analysis at the Department of Health and Human Services, Don Moulds, and Jane Tilly from the Administration for Community Living, presented on the National Plan to Adresss Alzheimer’s Disease, HHS’ progress on meeting their caregiving-related goals, and implementation opportunities that remain. Other experts presented on best practices for delivering patient –centered care and provided tools and strategies for implementing comprehensive programs in individual localities.

To view the agenda, speaker presentation and the conference recording, visit

ACT-AD Member Hosts 8th Drug Discovery for Neurodegeneration Conference

The Alzheimer’s Drug Discovery Foundation’s (ADDF) 8th annual Drug Discovery for Neurodegeneration conference is taking place on February 2-4, 2014 in Miami, FL. Focusing on Alzheimer’s disease, Parkinson’s disease, and Multiple Sclerosis, the conference is designed as a comprehensive course on the drug discovery process, from target validation through to clinical development. The annual conference seeks to provide participants with the knowledge and resources to translate their research into new drugs for neurodegenerative diseases.

ADDF-funded investigators and other top level scientists in the field will present their current research progress and stimulate discussion. Guests will include over 150 key stakeholders from the pharmaceutical, biotechnology, government, and academic communities. Attendees will learn from specific case studies examples and have an opportunity to engage in interactive session on securing valuable partnerships. A journal publication of conference outcomes will be published following the event.

For more information on the conference and registration details, click here.