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Alliance President Makes Remarks at a Hearing on Prescription Drug User Fee Act Reauthorization

Date: April 1st, 2010

On April 12th, Alliance President & CEO Daniel Perry presented remarks at a public meeting on the reauthorization process for the Prescription Drug User Fee Act (PDUFA). PDUFA IV, currently set to expire in September of 2012, authorizes the Food and Drug Administration (FDA) to collect user fees from companies wishing to submit their products for agency review. The intention is that the fees would be used to provide an additional revenue stream for FDA to hire more staff, improve systems, and establish a better managed drug review process to speed up the delivery of needed therapies to the public.

The PDUFA reauthorization process has historically been conducted through negotiations between the Agency and regulated industries, however the current round of negotiations are open to broader participation and transparency. The FDA will be seeking feedback from patient and consumer groups as well as the general public before entering into formal negotiations with industry and also before submitting its recommendations to Congress. This meeting was the first opportunity the patient community had to comment on how it views the performance of PDUFA and what elements should be reconsidered in the PDUFA V reauthorization.

In his remarks, Mr. Perry stressed the importance of FDA increasing stakeholder involvement in the regulatory process to address any barriers that slow patient access to new therapies. He also emphasized the need for FDA to have the ability to play a more significant role in encouraging the development of new therapies for diseases like Alzheimer’s disease, by providing guidance on streamlining clinical trial designs, the qualifying biomarker for use in development, and assessing the benefits and risks of new therapies post-approval so as not to delay treatments for patients who may benefit from them. Lastly, Mr. Perry highlighted the fact that user fees cannot be the sole source of support for the FDA; they must be balanced with Congressional appropriations. The full text of Mr. Perry's remarks can be downloaded from the link on this page.

Meeting Summary

Exploring Scientific Evaluation and Intake Recommendations of Bioactive Compounds and the Public/Private Path to Get There

Author: Alliance for Aging Research

Date: December 15th, 2014

On October 23, 2014, the Alliance for Aging Research, with support from Mars, Inc., convened key stakeholders from the Institute of Medicine (IOM) and other non-profit organizations, the U.S. and Canadian Governments, academia, and private industry to discuss scientific evaluation of bioactive compounds. Dr. Joanne Lupton, Distinguished Professor of Nutrition at Texas A&M University, co-chaired the meeting with Susan Peschin, President and CEO of the Alliance for Aging Research, and described the goals of the meeting as follows: (1) to identify concrete ideas for creating an evaluation process for bioactives, including intake recommendations, and (2) to address issues with and opportunities for public-private partnerships. She also shared a working definition of bioactive compounds and suggested it be used for the discussion: Bioactives, according to the working definition, are “constituents in foods or dietary supplements, other than those needed to meet basic human needs, which are responsible for changes in health status.”

The meeting included four presentations that helped frame the discussion. These presentations were on perspectives from the Subcommittee on Dietary Reference Intakes (DRIs), application of the DRI paradigm to bioactives, lessons learned from research on cocoa flavanols, and development of public-private partnerships.

Download the full meeting summary to learn more.

Public Comments

FY17 ACT-AD FDA Appropriations Request Letter

Author: Cynthia Bens

Date: March 17th, 2016

Letter to the House and Senate Appropriations Subcommittees on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies urging the Subcommittee to prioritize the U.S. Food and Drug Administration's (FDA) during Fiscal Year (FY) 2017 by increasing the agency's appropriated funding by $120 million. 

Public Comments

Letter on CMS Proposed LTCF Rule

Author: Sue Peschin

Date: September 14th, 2015

The Alliance for Aging Research commented on the Centers for Medicare & Medicaid Services (CMS) proposed rule changes regarding Infection Prevention and Control Programs (IPCP) in long-term care facilities (LTCFs). The Alliance recommended:

  • A full implementation madate within two years of the final rule
  • Mandating the CDC's National Healthcare Safety Network (NHSN) for surveillance of Healthcare Associated Infections by LTCFs
  • CMS work directly with the CDC to outline specific programs that LTCFs should follow to fulfill mandates
  • CMS should mandate the CDC's CORE Elements for Antibiotic Stewardship in LTCFs
  • Contact information for an Infection Prevention and Control Officer (IPCO) be made publicly available for family members of LTCF patients
  • CMS should provide language mandating the use of influenza vaccinations among direct-contact health care workers in LTCFs and set targets for vaccination rates

Public Comments

Comments on Oversight Framework for Molecular Diagnostic Tests, including Laboratory Developed Tests (LDTs)/Senate Version

Author: Various Organizations

Date: January 24th, 2017

This letter to Senate Majority Leader Sen. Mitch McConnell and Senate Minority Leader Sen. Charles Schumer that urges them to "make updating the oversight framework for all molecular diagnostic tests, including laboratory developed tests (LDTs), a priority early in the 115th Congress." 

Public Comments

Comments on Oversight Framework for Molecular Diagnostic Tests, including Laboratory Developed Tests (LDTs)/House Version

Author: Various Organizations

Date: January 24th, 2017

This letter to House Speaker Rep. Paul Ryan and House Minority Speaker Rep. Nancy Pelosi urges them to "make updating the oversight framework for all molecular diagnostic tests, including laboratory developed tests (LDTs), a priority early in the 115th Congress."

Public Comments

Letter to President Trump on Federal Public Health and Biomedical Research Workforce and Federal Hiring

Author: Various

Date: February 27th, 2017

The Alliance for Aging Research joined other organizations in calling on President Donald J. Trump to consider of the vital role of the federal public health and biomedical research workforce to the United States as he considers long-term policy regarding federal hiring.

Public Comments

FY 2018 Labor, HHS, Education, and Related Agencies Appropriations Testimony from the Alliance

Author: Cynthia Bens

Date: March 7th, 2017

This is testimony from the Alliance for Aging regarding the Fiscal Year 2018 Labor, Health and Human Services, Education, and Related Agencies appropriations process. It notes that "there is an ever-increasing need for sustained investment in the NIH, CDC, and AHRQ. Our testimony will highlight critical health concerns that disproportionately affect older adults and initiatives supported by our federal health agencies that are addressing them."



Testimony before Energy and Commerce Committee, Subcommittee on Health, on Examining FDA’s Medical Device User Fee Program

Author: Cynthia Bens

Date: March 27th, 2017

On March 28, Alliance for Aging Research Vice President of Public Policy Cynthia Bens testified before the United States House of Representatives' Energy and Commerce Committee, Subcommittee on Health, at its hearing
on the FDA’s Medical Device User Fee Program.

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