The American Autoimmune Related Diseases Association takes positions from time to time on health related issues and legislation.
**Recent advocacy efforts:
08/02/16 AARDA sent a letter of comment to FDA Commissioner Robert Califf concerning Labeling for Biosimilar Products; Draft Guidance for Industry.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 here FDA Biosimilars Naming Guidance (FDA-2016-D-0643)
AARDA is supportive of the 21st Century Cures Act.
Update December 13, 2016: President Barack Obama signed the “21st Century Cures” Act into law.
Read more in our press release: final-release-21st-century-cures-law
Autoimmune diseases need cures. Although there are treatments for many of the autoimmune diseases that can alleviate symptoms, few available treatments actually alter the course of an autoimmune disease. Most treatments for autoimmune diseases must be taken on a continuous basic, often for a lifetime. Although many of the treatments can have serious and undesirable side effects, patients are left with no other choice than to tolerate the treatments as they live with their chronic illnesses. Cures are needed. Research funding is crucial to finding cures.
AARDA supports legislation that holds the promise of future cures and includes reforms that will lessen the time currently seen to achieve effective treatments.
Learn about the act here: https://energycommerce.house.gov/cures
- 6/23/15 Here is one of many letters to which we have lent our name. [Update: The 21st Century Cures Act was overwhelmingly passed by the House on July 10th]
05/09/16 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 letter AARDA Comments to CMS-1670-P (05.09.16)
05/01/16 AARDA participated in a letter to the FDA upholding distinguishable names for biologics and biosimilars
- Read letter FDA-Patient-Naming-Letter-5-2
**Other advocacy efforts on behalf of autoimmune patients:
03/12/16 AARDA sent letter to Representatives in the Kentucky House to show support of SB134 regarding the pharmacy substitution of biosimilar medical products.
- Read the letter AARDA_KY March 12 2016
03/04/16 AARDA participated in a letter with the MAPRx Coalition to CMS (Center for Medicare and Medicaid Services which addressed 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
Comment letter MAPRxCoalitionCommentstoCMSon2017CallLetter(2)
03/04/16 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.
02/22/16 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 the letter AARDA_Idaho Feb 22 2016
01/22/16 AARDA submitted a letter regarding the Health Carrier Prescription Drug Benefit Management Model Act, MDL 22
- Comment letter AARDA Comments to NAIC Model Act 012016
10/28/15 AARDA submitted comments to the FDA regarding Nonproprietary Naming of Biological Products; Draft Guidance for Industry.
9/17/15 The US Senate Committee on Health, Education, Labor, and Pensions conducted a hearing to assess the progress of the FDA in implementing biosimilars: “Biosimilars Implementation: A Progress Report from FDA”
7/25/15 AARDA’s president and executive director Virginia Ladd, pens OpEd which appeared in the Editorial Section of the Detroit News.
7/13/15 AARDA cosponsors Biosimilars Briefing on Capitol Hill.
6/23/15 AARDA is supportive of the 21st Century Cures Act. Here is one of many letters to which we have lent our name. [Update: The 21st Century Cures Act was overwhelmingly passed by the House on July 1oth]
6/16/15 AARDA and the NCAPG represents AD patients at the UN World Health Organization meeting in Geneva, Switzerland on June 16, 2015. The meeting was on International Nonproprietary Names (INN) Biological Qualifiers (BQ) to continue its development of a worldwide accepted naming convention for biologic and biosimilar drugs.
6/01/15 AARDA’s Board of Directors approved a Policy Statement on Biologics
3/6/15 AARDA’s Statement on the FDA’s Approval of the First U.S. Biosimilar Drug
3/6/15 AARDA releases paper on Biologics-Biosimilars
- Press Release: BiosimilarsWhitePaperPressRelease
- Read the paper: Biologics-Biosimilars-BookletFINAL