Patient Advocacy Groups Urge Congress to Hold Hearings to Address Patient Safety on Biosimilars

February 1, 2018 – Patients for Biologics Safety & Access (PBSA), a national coalition of more than 20 patient advocacy organizations, today called on the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) and the U.S. House Committee on Energy and Commerce to convene oversight hearings to assure that patient safety and access are being fully protected as more biosimilars enter the market. The hearing would be especially timely as the FDA approved five biosimilars in 2017 alone, bringing the total to nine approved biosimilars. The U.S. Congress held hearings and approved the reauthorization of the Biosimilar User Fee Act (BsUFA) in 2017, but it has not held an oversight hearing on biosimilars since 2016.

“Millions of Americans who rely on biologics and biosimilars to manage their health depend on the safety and effectiveness of these drugs to live a healthy, stable life,” said Larry LaMotte, Vice President of Public Policy at the Immune Deficiency Foundation and lead coordinator of PBSA. “As more biosimilars come to market, it is critical that Congress ensure that the FDA is prioritizing patient safety through its guidance, approvals, education and post-market surveillance.”

In their requests to the U.S. House and Senate, PBSA calls on the FDA to:

  • Take additional steps to protect people from harmful insurance practices, such as non-medical switching involving non-interchangeable biosimilars;
  • Evaluate post-marketing surveillance activities to assure all biologics, newly approved biosimilars, and interchangeable products are tracked for adverse events; and
  • Educate patient and provider audiences about the implementation of the Biologics Price Competition and Innovation Act (BPCIA) and introduction of biosimilars into the market.

“PBSA is already working with the FDA to provide feedback on their biosimilar education initiatives and looks forward to continuing to work with them to ensure the patient voice is front-and-center in future efforts to educate Americans about the efficacy and reliability of biosimilars,” added LaMotte.

About Patients for Biologics Safety & Access

 Patients for Biologics Safety & Access (PBSA) brings together a variety of patient advocacy groups with a common interest in ensuring that patients have access to safe and effective biologic medicines.

Members include: American Autoimmune Related Diseases Association, Arthritis Foundation, Committee of Ten Thousand, Crohn’s & Colitis Foundation of America, Dystonia Medical Research Foundation, GBS/CIDP Foundation International, Hemophilia Federation of America, Hepatitis Foundation International, Immune Deficiency Foundation, International Foundation for Autoimmune Arthritis, Jeffrey Modell Foundation, Lupus and Allied Diseases Association, Lupus Foundation of America, National Organization for Rare Disorders, National Psoriasis Foundation, Platelet Disorder Support Association, Pulmonary Hypertension Association, RetireSafe, Scleroderma Foundation, Spondylitis Association of America, United Spinal Association, US Hereditary Angioedema Association, U.S. Pain Foundation. For more information, visit www.BiosimSafety.org or @BiosimSafety on Twitter.

 

Comment