How can you help? Currently, state governments across the country are holding hearings to debate the introduction, modification, or total removal of Fail First/Step Therapy policies in their state. Through your grassroots advocacy as part of the 50 State Network— online and in-person — the Fail First message of poor outcomes, inefficiencies, and higher costs […]
1. When a patient has to fail first on a drug before being allowed to take the medication originally prescribed, the patient, physician and public health suffers. 2. Fail first policies intrude on the patient/physician relationship and lead to: Prolonged illness Unstabilized care and the potential for permanent damage to occur Higher overall healthcare […]
On September 26th GHLF submitted a letter to Commissioner Hamburg at the FDA written by GHLF Chief Medical Officer, Dr. Jonathan Krant. The letter explains that biosimilars are not like generic drugs. A biosimilar product is highly similar to, but not the same as it’s reference biologic product. Therefore, from a patient safety perspective, it is […]
As patients, our core concerns are to safeguard safety and the physician-patient relationship. Physicians and their patients are in the best position to determine appropriate therapies
￼In March 2010, a U.S. biosimilar pathway was signed into law as part of the Affordable Care Act (ACA). In February 2012, the Food and Drug Administration (FDA) issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. What, if any, additional guidance FDA may issue, and when, is uncertain.