The American Autoimmune Related Diseases Association takes positions on health related issues and legislation to improve the lives of AD patients and their families.

Current Issues

Prescription Drug User Fee Act (PDUFA)

The Prescription Drug User Fee Act (PDUFA) expires in September of 2017 and it is critical that it be reauthorized. The Act has helped increase the number of treatments available to patients while researchers continue to search for cures. Patients need new and innovative treatments.  This Fight is for All of Us.

American Health Care Act (AHCA)

The 115th Congress currently is working to repeal the Patent Protection and Affordable Care Act (ACA) via the American Health Care Act (AHCA). AARDA wants to ensure meaningful and affordable patient access to care, coverage for pre-existing conditions, and the elimination of annual and lifetime benefit caps. AARDA’s goal is for Congress to consider the consequences of limiting access to care for the 133 million Americans with chronic diseases and disabilities. Health insurance needs to be more affordable and accessible, and should offer comprehensive coverage options, including preventative services, long-term and end-of-life care, robust provider networks, and formularies with affordable and predictable out-of-pocket costs. AARDA urges our supporters to contact their members of congress and tell them how health care impacts you. For more information visit http://www.nationalhealthcouncil.org/healthreform

AARDA Advocacy Timeline

View our timeline

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AARDA sends comment letter to CMS regarding biosimilar payment policies

AARDA sent a letter to the Centers for Medicare and Medicaid Services. This letter urges CMS to implement changes to the current Part B payment policy for biosimilar biological products. Read our letter 

September 2017
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President Obama Signs 21st Century CURES Act into Law

Read our press release.

December 2016
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AARDA Sends Letter to FDA Commissioner on Biosimilar Labeling

AARDA sent a letter of comment to FDA Commissioner Robert Califf concerning Labeling for Biosimilar Products; Draft Guidance for Industry. These comments focus on the importance of clear and transparent information on biosimilars labeling to ensure that prescribers and patients can make knowledgeable and safe medication decisions, particularly for patients with complex and chronic conditions. We are pleased to note that this letter was signed by an additional 10 single disease groups. Read our letter.

August 2016
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AARDA and NCAPG Send Letter to CMS on Medicare Part B proposed rule

AARDA sent concerns to CMS regarding the Medicare Program;Part B Drug Payment Model Proposed Rule. Several NCAPG members also signed on to our comment letter. Read our letter.

May 2016
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AARDA co-authors Letter to FDA on Distinguishable Naming

AARDA participated in a letter to the FDA upholding distinguishable names for biologics and biosimilars. Read the letter.

May 2016
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AARDA Supports Pharmacy Substitution of Biosimilar Medical Products in Kentucky

AARDA sent a letter to the Kentucky House of Representatives in support of SB13 regarding the pharmacy substitution of biosimilar medical products. Read our letter.

March 2016
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AARDA Joins MAPRx Coalition to Address AD Issues

AARDA co-signs MAPRx Coalition letter to the Center for Medicare and Medicaid Services addressing the following issues:

  • Specialty Tier Threshold
  • Tier Labeling and Composition
  • Generic Tier $0 Copay Plans
  • Formulary Oversight
  • Drug Utilization Review Controls
  • Coverage Determination Timelines
  • Access to Preferred Cost-Sharing Pharmacies

Read the letter.

March 2016
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AARDA Supports Pharmacy Substitution of Biosimilar Medical Products in Connecticut

AARDA sent a letter to the Co-Chairs of the General Law Committee in the Connecticut General Assembly in support of SB 313 regarding the pharmacy substitution of biosimilar medical products. Read our letter.

March 2016
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AARDA Supports Pharmacy Substitution of Biosimilar Medical Products in Idaho

AARDA sent a letter to the Chair, House Health & Welfare Committee in Idaho in support of HB 483 regarding the pharmacy substitution of biosimilar medical products. Read our letter.

February 2016
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AARDA Comments on Health Carrier Prescription Drug Benefit Management Model Act

AARDA submitted a letter regarding the Health Carrier Prescription Drug Benefit Management Model Act, MDL 22. Read our comments.

January 2016
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AARDA Comments on FDA Nonproprietary Naming of Biological Products

AARDA submitted comments to the FDA regarding Nonproprietary Naming of Biological Products; Draft Guidance for Industry. Read our comments.

October 2015
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Biosimilars Implementation: A Progress Report from FDA

he US Senate Committee on Health, Education, Labor, and Pensions conducted a hearing to assess the progress of the FDA in implementing biosimilars. Read AARDA’s writeup.

September 2015
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Detroit News: 'Don't cap prescription drug prices!'

AARDA President and Executive Director Virginia Ladd, pens OpEd opposing prescription drug prices fearing a reduction in drug research. Read the article at www.DetroitNews.com

July 2015
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AARDA cosponsors Biosimilars Briefing on Capitol Hill

Read the Briefing Writeup

July 2015
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U.S. House Passes 21st Century CURES Act

July 10, 2015
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AARDA joins National Health Council and 250 organizations to support the 21st Century CURES Act

Read the National Health Council Letter of Support

June 2015
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AARDA and NCAPG Call for Worldwide Naming Convention at U.N.

AARDA and NCAPG encourage the World Health Organization (WHO) to continue development of a worldwide accepted naming convention for biologic and biosimilar drugs during the International Nonproprietary Names (INN) Biological Qualifiers (BQ) meeting. Read the WHO Report.

June 2015
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AARDA Issues Policy Statement on Biologics

Read our Statement of Principles on Biologic Medicines

June 2015
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AARDA releases paper on Biologics-Biosimilars

Read our PressRelease or Download our Biologics Biosimilars Booklet

March 2015
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FDA Approves First U.S. Biosimilar Drug

Read our Press Release

March 2015