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50 State Network Advocate Brief: Fail First/Step Therapy

Jan 29/GHLF Staff / Memos Seth's 50 State Network

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 […]

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50 State Network Advocate Talking Points: Fail First/Step Therapy

Jan 29/GHLF Staff / Seth's 50 State Network Talking Points

  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 […]

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GHLF Submits Letter to FDA Requesting Distinguishable Names for Biosimilars

Jan 13/GHLF Staff / Biosimilars Memos Seth's 50 State Network

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 […]

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50 State Network Advocate Talking Points: Biosimilars

Jan 04/GHLF Staff / Biosimilars Seth's 50 State Network Talking Points

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

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50 State Network Advocate Brief: Biosimilars

Jan 04/GHLF Staff / Memos Seth's 50 State Network

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 In February 2012, the Food and Drug Administration (FDA) issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.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.

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