Drugs

Public Citizen Cautions Congress on ‘Right to Try’ Bills

Consumer advocacy group Public Citizen is urging Congress to reject three “right to try” bills (S 204, HR 878 and HR 1020) because they would “put countless patients at risk by dramatically undermining the FDA’s role in ensuring that medical products are safe and effective before they become widely used.” In a 3/6 letter to Congress, the group said the bills “would undermine incentives for companies to swiftly develop life-saving products for FDA approval and impair review of these products by limiting the agency’s access to unfavorable information... These bills provide false hope to patients and are related to a nationwide lobbying effort funded by the Goldwater Institute, which has deceptively branded such laws as ‘right to try’ legislation.”

Public Citizen reminded lawmakers that the best way for patients to gain early access to unapproved therapies is through FDA’s Expanded Access Program, “which allows seriously ill patients to receive treatment with experimental drugs, biological products or medical devices while also providing basic safeguards to protect patients’ rights and welfare and maintaining strong incentives for careful clinical testing and timely product development.” The program protects patients by requiring informed consent, ethical review by an institutional review board, safety monitoring and adverse event reporting to FDA. It also prevents manufacturers from profiting from the use of experimental products. The group noted that the agency grants 99% of all Expanded Access Program requests and, in urgent circumstances, can respond to such requests within a day or two.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome