Statement in Support of the Prescription Drug User Fee Act (PDUFA)

3/22/2017

The Sjögren's Syndrome Foundation strongly urges the reauthorization of the Prescription Drug User Fee Act (PDUFA) to ensure timely approval of new and safe medications by the U.S. Food and Drug Administration (FDA). Millions of patients, including those who suffer from the second most common autoimmune rheumatic disease, Sjögren's, will suffer needlessly if PDUFA is not reauthorized.

Because of the increased number and complexity of drugs entering regulatory review in this modern era, user fees are critical to enable the FDA to keep pace with the approval process. Before the initial passage of PDUFA in 1992, most medicines were approved outside the U.S. due to the lengthy time it took to get drug reviews through the FDA. Following PDUFA, drug approval time was reduced in half and more than 1500 drugs have been authorized by the FDA. PDUFA encourages scientific innovation and makes it possible for our country to bring new treatments to market for the many patients who desperately need them.

Click here to download the statement

 

This April is Sjögren’s Awareness Month. Each day of the month, the Sjögren’s Syndrome Foundation (SSF), will be using one or more of its social media channels to educate people about Sjögren’s, an autoimmune disorder affecting more than 4 million Americans, with an estimated 2.5 million patients currently undiagnosed.

Please consider further supporting our efforts by using your social media channels to follow, like, share, and comment on some of the SSF’s selected posts and using the #ThisIsSjögrens hashtag! 

• Twitter
• Facebook
• LinkedIn

With your added support, you can help shine a light on Sjögren’s to ensure greater awareness and understanding of this disease and help patients get an early diagnosis and proper treatment that may prevent serious complications and greatly improve their quality of life. 

Thank you, 

Steven Taylor
Chief Executive Officer

 

"More than 4mm Americans are living with Sjögren's, a systemic autoimmune disease that affects the entire body. Nine out of ten patients are women. Let me repeat this: 9/10 patients are women. Kathy Hammitt, Chair of the TFOS Public Awareness & Education Subcommittee, is Vice President of Medical & Scientific Affairs at Sjögren's Syndrome Foundation in Washington, DC. A patient herself, she is a strong advocate for change, overseeing SSF’s key research and medical initiatives to increase our knowledge about Sjögren’s, improve the exchange of ideas to accelerate research, and set the stage for better treatment and management of Sjögren’s through awareness and fund raising. Her battle has just begun. Read our interview here."

-Dominica Drazal

Director, TFOS Global Ambassador Program

2017 National Patient Conference

March 31 – April 1
Crowne Plaza Philadelphia/Cherry Hill
2349 West Marlton Pike Cherry Hill, New Jersey

Presentation topics will include:

• Sjögren’s Overview
• Pulmonary Issues and Sjögren’s
• Oral Manifestations of Sjögren’s
• Pediatric Sjögren’s
• Ocular Manifestations of Sjögren’s
• Men with Sjögren’s
• Social Security Disability for Sjögren’s
• Neurological Complications and Sjögren’s
 Are you Collecting Autoimmune Diseases?

Click here to view the 2017 NPC brochure

We hope to see you at our upcoming Conference!

Thank you to our Premier Sponsor:

 

 

 

 

New classification criteria for Sjögren’s were published in the fall of 2016! Classification criteria are for use in clinical trials to ensure that the patient population participating in a drug trial definitely has a disease. As a result, classification criteria are much stricter than diagnostic criteria used for patients in the clinician’s office, and many patients might not fit classification criteria but still be diagnosed as having Sjögren’s.

The latest set of classification criteria have been endorsed by both the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) and were published simultaneously in the ACR journal, Arthritis and Rheumatology, and the EULAR journal, Annals of Rheumatic Disease. This international effort was led by Caroline Shiboski, DDS, MPH, PhD and Stephen Shiboski, PhD, of the University of California San Francisco with other international leaders in Sjögren’s and in conjunction with the International Sjögren’s Syndrome Criteria Working Group. Formerly, two sets of classification were in use: the 2002 American European Consensus Group classification criteria and the 2012 ACR classification criteria.

The Sjögren’s Syndrome Foundation (SSF) brought the international community together by hosting meetings so that Sjögren’s leaders in the U.S. and Europe could agree on one set of classification criteria, paving the way for a clear path to designing and pursuing clinical trials in Sjögren’s. The SSF was honored to be part of this key initiative that will make a tremendous difference for patients and physicians and encourage companies to pursue the development of potential therapies for Sjögren’s.

2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjögren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts.
Click here for Abstract