Public Policy

One of the Alliance’s most important missions is to advocate for aging research by working with legislators, health experts and other like-minded organizations. Our public policy efforts are summarized here.

FDA & Regulatory Policy

Press Room

Alliance Statement on FY 2018 White House Proposed Budget on NIH, FDA, CDC

Author: Susan Peschin, MHS

Date: May 23rd, 2017

Alliance President and CEO Susan Peschin, MHS, has issued the following statement in response to the White House’s proposed Fiscal Year 2018 budget.


Alliance Thanks Senate HELP Committee for Advancing FDA Commissioner Nomination of Dr. Scott Gottlieb

Author: Susan Peschin, MHS

Date: April 27th, 2017

Alliance for Aging Research President and CEO Susan Peschin, MHS, has issued the following statement thanking Chairman Lamar Alexander and the U.S. Senate HELP Committee for advancing the nomination of Dr. Scott Gottlieb as U.S. Food and Drug Administration (FDA) commissioner to the full Senate for a vote.


Alliance's Bens Offers Testimony on User Fee Programs before Senate HELP Committee

Author: Noel Lloyd

Date: April 4th, 2017

Today, the Alliance for Aging Research's (Alliance) Vice President of Public Policy Cynthia Bens testifies before the U.S. Senate HELP Committee on reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA).


Alliance Statement on Nomination of Dr. Scott Gottlieb for FDA Commissioner

Author: Susan Peschin, MHS

Date: April 3rd, 2017

Alliance for Aging Research President and CEO Susan Peschin, MHS, has issued a statement in support of the nomination of Scott Gottlieb, M.D., to be commissioner of the U.S. Food and Drug Administration (FDA).


Alliance's Bens Offers Testimony on MDUFA before House Committee

Author: Cynthia Bens

Date: March 28th, 2017

Today, the Alliance for Aging Research's Vice President of Public Policy Cynthia Bens testifed before the U.S. House of Representatives' Energy and Commerce Committee, Subcommittee on Health, in regard to reauthorization of the Medical Device User Fee Act (MDUFA).


Statement on Congressional Action to Reauthorize the FDA’s Prescription Drug and Medical Device User Fee Programs

Author: Cynthia Bens

Date: March 22nd, 2017

Alliance for Aging Research Vice President of Public Policy Cynthia Bens issued the following statement regarding congressional action taken this week to begin consideration of the U.S. Food and Drug Administration’s (FDA) prescription drug and medical device user fee programs.


Alliance and 90+ Organizations Urge Senate Committee Chairs to Safeguard U.S. Vaccine Policy during Price Confirmation Process

Author: Noel Lloyd

Date: January 19th, 2017

The Alliance has joined with more than 90 national organizations in urging the Senate to ensure Secretary of HHS nominee Tom Price, M.D., is committed to protecting U.S. citizens from vaccine preventable diseases.


AIM Coalition Meeting Spotlights Sarcopenia Research Advances

Author: Noel Lloyd

Date: December 2nd, 2016

The Aging in Motion (AIM) Coalition hosted its second annual meeting with U.S. Food and Drug Administration (FDA) leaders and leading scientists, industry representatives, and advocates to discuss developments and advances in clinical research and treatment of sarcopenia in Bethesda, Md.


Experts Explore Federal Agency Collaborations to Close Alzheimer’s Disease Research Gaps at ACT-AD Coalition Annual Meeting

Author: Noel Lloyd

Date: November 16th, 2016

Today, senior representatives from the U.S. Food and Drug Administration (FDA) and the National Institute on Aging at the National Institutes of Health (NIH) joined with advocates, federal colleagues, researchers, and industry to explore collaborations for advancing the most up-to-date knowledge in Alzheimer’s disease research. 


Cynthia Bens Named as President of the Alliance for a Stronger FDA Board of Directors

Author: Noel Lloyd

Date: February 5th, 2016

Cynthia Bens has been named as the president of the Alliance for a Stronger FDA Board of Directors.


Leading Experts Assess the Current State of Alzheimer’s Disease Therapeutic Development

Author: Noel Lloyd

Date: September 16th, 2015

ACT-AD Coalition Hosts Its Eighth Annual Meeting


New Survey Shows Americans Prefer Education Over Restricted Access When It Comes to OTC Pain Medications

Author: Noel Lloyd

Date: March 9th, 2015

Results Also Reveal Many Older Adults Use OTC Medications to Relieve Pain


Leading Experts Discuss Clinical Meaningfulness in Drug Development for Early Alzheimer’s Disease

Author: Noel Lloyd

Date: November 6th, 2014

ACT-AD Coalition Hosts Its 7th Annual Meeting


Statement on FDA Draft Guidance for Alzheimer’s Drug Development

Date: February 7th, 2013

Accelerate Cure/Treatments for Alzheimer’s Disease (ACT-AD) coalition released a statement in response to guidance from the U.S. Food and Drug Administration (FDA) on the development of drugs for Alzheimer’s Disease.


Use Biomarkers in Alzheimer's Disease Clinical Trials

Date: January 4th, 2012

Use biomarkers in Alzheimer's disease clinical trials, says expert group.


Advocates: FDA deal with drug makers "opaque"

Author: J. Lester Feder, Politico Pro

Date: June 8th, 2011

Consumer advocates are blasting the FDA for the process it has used to renegotiate the terms of the drug approval process following news that a deal has been reached with industry on proposed changes to the process.


Alliance Commends Senate Committee for Increase in FDA Funding

Date: July 17th, 2007

The Alliance for Aging Research today commends the Senate Agriculture, Rural Development, FDA and Related Agencies Appropriations Subcommittee for including a $186 million increase for the U.S. Food and Drug Administration (FDA) in its Fiscal Year 2008 appropriations bill.


President's Budget Lacks Funds to Stem 'Silver Tsunami'

Date: February 7th, 2007

The Alliance for Aging Research today warned that the president’s proposed FY 2008 budget lacks sufficient funding to address the growing burden of age-related chronic diseases. 

Publications



Public Comments

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

Author: Cynthia Bens

Date: 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."

 



Public Comments

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

Author: Various

Date: 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

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

Author: Various Organizations

Date: 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: 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

FY17 ACT-AD FDA Appropriations Request Letter

Author: Cynthia Bens

Date: 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: 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







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: 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.



Testimony

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

Date: 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.

Blog

Five Questions (and Answers) about the FDA Reauthorization Act of 2017

Author: Noel Lloyd

Date: July 12th, 2017

Right now, the U.S. Congress is considering the FDA Reauthorization Act of 2017 , legislation that will reauthorize the pharmaceutical, medical device, generic drug, and biosimilar user fee agreements. The five-year deal is one of the most important health care bills Congress will vote on this year.


Tomorrow Is the March for Science

Author: Noel Lloyd

Date: April 21st, 2017

This Saturday, April 22, thousands of people will gather in the shadow of the Washington Monument to march for not just a cause, but in support of one of humanity’s most important endeavors: science.


Alliance Issues Statement on the Protect Medical Innovation Act of 2017

Author: Noel Lloyd

Date: January 3rd, 2017

The Alliance has issued the following statement from President and CEO Susan Peschin, MHS, regarding the introduction of the Protect Medical Innovation Act of 2017


AIM Coalition Held Second Annual Meeting

Author: Breanna Bishop

Date: December 15th, 2016

On December 2, the Aging in Motion (AIM) Coalition hosted its second annual meeting in Bethesda, Md., to discuss developments and advances in clinical research and treatment of sarcopenia.


Alliance Releases Statement on Passage of 21st Century Cures

Author: Noel Lloyd

Date: December 7th, 2016

The Senate today approved landmark legislation overhauling the development of medical treatments and cures for patients, which represents the culmination of a multi-year, bipartisan initiative in Congress. Here is a statement from Alliance President and CEO Sue Peschin.


ACT-AD Coalition Holds Ninth Annual Meeting

Author: Breanna Bishop

Date: November 22nd, 2016

On November 16, the ACT-AD (Accelerate Cure/Treatments for Alzheimer’s Disease) Coalition hosted its Ninth Annual FDA/Alzheimer’s Disease Allies Meeting in North Bethesda, Md., to discuss the current state of Alzheimer’s disease treatment development.


An Update on 21st Century Cures

Author: Noel Lloyd

Date: October 31st, 2016

We provide an update on the 21st Century Cures Act, an important piece of legislation that the Alliance has been advocating for.


ACT-AD Will Host Ninth Annual Meeting

Author: Breanna Bishop

Date: October 31st, 2016

The ACT-AD Coalition will host its Ninth Annual FDA/Alzheimer's Disease Allies Meeting on November 16, 2016. 


Alliance Comments on the FDA's Commitment Letter for PDUFA VI

Author: Noel Lloyd

Date: August 30th, 2016

In response to a call from the U.S. Food and Drug Administration (FDA) for feedback on its proposed Commitment Letter for the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA), the Alliance for Aging Research submitted comments to the FDA for consideration.


Alliance’s Bens Presents at August PDUFA VI Public Meeting

Author: Noel Lloyd

Date: August 18th, 2016

The Alliance’s Vice President of Public Policy Cynthia Bens was invited by the U.S. Food and Drug Administration (FDA) to speak on two panels at an August 15 public meeting focused on the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA).


Alliance Offers Comments on FDA OTC Monograph User Fees

Author: Noel Lloyd

Date: June 15th, 2016

Last Friday, on June 10, Vice President of Public Policy Cynthia Bens presented comments on behalf of the Alliance at a U.S. Food and Drug Administration public meeting focused on OTC monograph user fees. 


The President’s Budget: Read the Numbers, Not the Headlines

Author: Ryne Carney

Date: February 18th, 2016

The Obama administration’s FY 2017 vision for the federal government does not include continuing increases for America’s biomedical research community.


A December Update on PDUFA and MDUFA

Author: Noel Lloyd

Date: December 22nd, 2015

A December update on PDUFA and MDUFA


Congress and the Omnibus Miracle

Author: Susan Peschin, MHS

Date: December 17th, 2015

Congress gave Americans a holiday miracle this week and reached a deal on a $1.1 trillion omnibus spending bill for FY 2016, increasing funding for NIH, NIA, and FDA.


HROTW: Infographic on What Americans Feel about Pain

Author: Noel Lloyd

Date: September 23rd, 2015

For our Health Resource of the Week, we share this infographic to make you aware about what Americans feel about pain and what they do to treat it.


ACT-AD Coalition Holds Eighth Annual Meeting

Author: Noel Lloyd

Date: September 18th, 2015

On September 16 the ACT-AD (Accelerate Cure/Treatments for Alzheimer's Disease) Coalition hosted its Eighth Annual FDA/Alzheimer’s Disease Allies Meeting in North Bethesda, Md.


HROTW: Learn More about Vaccinations

Author: Noel Lloyd

Date: August 27th, 2015

Our Health Resource of the Week focuses on some of the ways you can learn about why vaccinations keep us safe, no matter what our age.  


Cynthia Bens Comments from MDUFA and PDUFA Meetings

Author: Noel Lloyd

Date: July 16th, 2015

Alliance Vice President of Public Policy Cynthia Bens took part in two important meetings at the U.S. Food and Drug Administration this week.


Alliance President and CEO Sue Peschin on Being at the White House Conference on Aging

Author: Noel Lloyd

Date: July 14th, 2015

Yesterday, the White House Conference on Aging was held in Washington, D.C. Our President and CEO Sue Peschin was among the individuals in attendance. 


Alliance Applauds Passage of 21st Century Cures Act in House

Author: Noel Lloyd

Date: July 10th, 2015

The Alliance for Aging Research has issued the following statement on the passage of the 21st Century Cures Act, or H.R. 6, today in the U.S. House of Representatives.


Expert Robert Fielding on the Latest in Sarcopenia Research

Author: Noel Lloyd

Date: June 30th, 2015

To help you learn more about what's been going on in the sarcopenia research space, we are linking you to an interview with Roger A. Fielding, Ph.D.


The 21st Century Cures Act: A Critical Bill to Improve the Future of Medical Research in America

Author: Noel Lloyd

Date: June 12th, 2015

The 21st Century Cures Act represents a positive change in how American biomedical research will be conducted and streamlines the processes intended to deliver new medical cures and treatment to patients.


Webinar: Targets for the Next Generation of Alzheimer’s Disease Treatment

Author: Noel Lloyd

Date: May 11th, 2015

On April 27 the Alliance's ACT-AD Coalition held a webinar on the future of research, therapeutic development, and treatment of Alzheimer’s disease.


Infographic on Pain Incidence and Management

Author: Noel Lloyd

Date: March 10th, 2015

Today we released a survey of 1,600 Americans ages 18 and over that reveals insights on pain and OTC pain medications. This infographic offers a summary of the results.


Alliance Offers Comment on FDA Testosterone Prescription Labeling Communication

Author: Noel Lloyd

Date: March 4th, 2015

Type: Blog Post

We wanted to share our reaction to communication from the U.S. Food and Drug Administration regarding updates to the labeling of prescription testosterone products.


Matching the Needs of Patients with Those of Our Federal Health Agencies

Author: Cynthia Bens

Date: February 12th, 2015

On Tuesday, the Alliance for Aging Research responded to the U.S. House Energy and Commerce Committee 21st Century Cures Initiative and its recently released discussion draft.


Don’t Just Act Out, Act to Increase Representation in Clinical Trials

Author: Cynthia Bens

Date: August 29th, 2014

Vice President of Public Policy Cynthia Bens talks about clinical trials.


Let This Be a Lesson for Change

Author: Susan Peschin, MHS

Date: August 26th, 2014

Alliance President and CEO Susan Peschin, MHS, on mental health in older adults


Turning a Blind Eye on Patients

Author: Cynthia Bens

Date: May 22nd, 2014

Type: Blog

Alliance Vice President of Public Policy Cynthia Bens discusses AMD and older adults. 


Are we there yet?

Author: Cynthia Bens

Date: January 6th, 2012

Many of you may still have this phrase ringing in your ears if you traveled with children for any length of time this past holiday season. Representatives from the ACT-AD Coalition, chaired by the Alliance for Aging Research, heard these same words almost two years ago, not uttered from the mouths of babes, but rather by prominent officials at the Food and Drug Administration (FDA) in a conversation regarding evidence to support the use of biomarkers for Alzheimer’s disease in clinical trials for “disease-modifying” therapies.


FDA Under Fire

Author: Guest Contributor

Date: November 14th, 2011

Last month, the FDA published a long awaited report on biomedical innovation, their only course of defense in the recent onslaught against the agency. Historically, the FDA has played a significant role in the protection of our health, assuming sole responsibility for the approval of medical products, but it appears that congressional confidence in the agency is waning.


PDUFA V Can Help Patients and the FDA

Author: Dan Perry

Date: June 30th, 2011

On June 26, 2011 I was interviewed by BioCentury This Week to share the Alliance for Aging Research’s impressions on the fifth reauthorization of the Food and Drug Administration’s Prescription Drug User Fee program. Thanks to Congress, we and other active patient groups were able to lend an early voice in helping to shape how user fees might be used to help speed the delivery of better treatments and cures to patient in need of relief from Alzheimer’s, Cancer, Parkinson’s and many more diseases.

 


A "Pro-Cures" FDA

Author: Dan Perry

Date: January 28th, 2009

One week into the Obama Administration and the choice of a new Commissioner of the Food and Drug Administration may be only days away. This is a critical moment for anyone who will face a life-threatening or life-shortening disease or disability. Aging Baby Boomers take note: in time, if not right now, the FDA choice will affect you directly and personally.


FDA Needs More Funding to Fulfill Its Mission

Author: Cynthia Bens

Date: March 18th, 2008

On February 4, 2008, the Bush administration released its proposed budget recommendations for funding all federal agencies in fiscal year 2009. Under this proposal, the U.S. Food and Drug Administration would receive a 2.9% overall increase in funding this year.

Newsletter

News-At-A-Glance

Date: December 13th, 2016

2016 has been a busy year at the Alliance. Learn more about what's been happening!


Break Out Your Pantookas and Drums, It is Time to Reauthorize the UFAs

Date: December 13th, 2016

In this edition of Get Mad before You Get Old, Cynthia Bens highlights the importance of swift reauthorization of the FDA user fee programs in the next Congress.


Highlights from This Year in Public Policy

Date: December 9th, 2015

From Capitol Hill to the NIH to the U.S. Food and Drug Administration, it was a busy year for the Alliance on the public policy front.


White Paper Lays Out Case for Increased Vaccination in Older Adults

Date: August 4th, 2015

As we recognize National Immunization Awareness Month in August, the Alliance has released a groundbreaking new paper on the importance of improving vaccination rates in older adults.


Can We Work the Bugs Out? In Search of the Next-Generation IPAB

Date: July 1st, 2011

An IPAB is not the latest device created by Apple to play music or store your online files. IPAB is the Independent Payment Advisory Board and its purpose is to oversee costs in Medicare. The only similarity between IPAB and an iPAD is that both are small and complex units with tremendous power to change lives. But for those receiving their health care under the Medicare program, IPAB’s changes may not be for the better.


What is the 510(k)? Balancing Benefits, Safety, and Patient Needs

Date: July 1st, 2010

What does a tongue depressor have in common with an artificial knee and a heart monitor? This is not trick question or an unsolvable riddle—all three are medical devices that must go through the U.S. Food and Drug Administration (FDA) for approval. Many of us are exposed to medical devices on a regular basis but few of us give much thought to who develops these products, and even fewer take the time to consider how their benefits and safety were measured. The process by which these products are evaluated and allowed for public use is essential to the quality of life of millions of people in the U.S., however most Americans know very little about it.

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