User Fee Reauthorization Update
On July 9, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law. The bill raises, by more than $2 billion from the previous five-year period, the fees that Food and Drug Administration (FDA) collects in exchange for the review of medical therapies including new sets of fees generated by the establishment of generic drugs and biosimilar review mechanisms.
The bill increased funding for foreign manufacturing facility inspections, an extra five years of market exclusivity for qualifying new antibiotics, measures to ease drug shortages and accelerated approval pathways for some breakthrough products. Not included in the bill, was the creation of a drug “track and trace” system, despite being included in the Senate version of the legislation.
ACT-AD supported the bill, submitting letters to the chairmen and ranking members of the authorizing committees during their conference on the House and Senate bills. The letter supported a number of enhancements that were ultimately included in the final bill. The letter specifically cited accelerating drug development through greater focus on regulatory science; supporting the development of innovative clinical trial designs; re-evaluating how the FDA assesses benefits and risks of therapies and communicates benefit-risk information; and ensuring that Risk Evaluation and Mitigation Strategies (REMS) do not serve as a barrier to patients in need of treatments, among other important components.
To view the bill, click here.
To view ACT-AD’s letter of support, click here.
NAPA Holds July Advisory Council Meeting
The Advisory Council on Alzheimer’s Research, Care, and Services, tasked with guiding the National Alzheimer’s Project Act, held its fifth meeting on July 23 in Washington, DC. The meeting included reports from a number of federal officials leading the implementation of the National Plan to Address Alzheimer’s Disease. Their reports addressed current progress of the Plan, and an explanation of how its implementation will be tracked.
One such report touched on work being done by ACT-AD Chair, Alliance for Aging Research, who hosted a meeting in partnership with the Administration on Aging, to discuss the translation of promising community and caregiver based pilot programs for people with Alzheimer’s disease and other Related Dementias into more broadly implemented programs.
The Department of Health and Human Services (HHS) expects to make initial recommendations on further implementation of a National Alzheimer’s strategy at Advisory Council’s next meeting scheduled for October 15. HHS hopes to have recommendations for the national strategy finalized by January, for announcement in the Spring of 2013.
ACT-AD Member Events
The Alzheimer’s Foundation of America to Host 10th Annual National Memory Screening Day
In honor of National Alzheimer’s Awareness Month, the Alzheimer’s Foundation of America, an ACT-AD member, is sponsoring its 10th annual National Memory Screening Day. On November 13, 2012 community sites nationwide will offer free, confidential memory screenings and educational materials to the public.
During the National Memory Screening Day, five to ten minute face-to-face screenings are administered by qualified healthcare professionals (i.e., physicians, psychologists, nurses, nurse practitioners, social workers, pharmacists). Screening sites include Alzheimer’s agencies, assisted living residences, long-term care facilities, doctors’ offices, hospitals, senior centers, YMCA’s, pharmacies and other local venues.
In 2011, 96,500 people participated at 2,540 community sites nationwide. To assist in this year’s National Memory Screening Day you can host a screening site, offer to be a screener, encourage people with memory concerns to be screened, or spread the word.
For more information visit www.nationalmemoryscreening.org.
FasterCures to Host Conference on Economic and Social Benefits of Scientific Research
The Celebration of Science, September 7-9 in Washington, DC, will be an intensive three days focused on jumpstarting a new era of scientific discovery. We’ll highlight the economic and social benefits of scientific research and how it improves lives around the world.
The weekend will include panels and brief presentations, a full day of activities on the campus of the National Institutes of Health and a FasterCures working meeting on accelerating innovation in the biosciences. On Saturday we’ll host a special evening at the Kennedy Center to honor several individuals who have made outsized contributions to science, including performances by popular entertainers.
Participants will include about 1,000 current and former elected officials, heads of government agencies, major philanthropists, leaders of academic research centers, patient advocacy groups, distinguished scientists, industry CEOs and the media.
For more information visit http://celebrationofscience.org.