Drugs

Stop Desiccated Thyroid Enforcement: Congressman

Rep. Abe Hamadeh (R-AZ) is calling on FDA to pause its recent enforcement actions against desiccated thyroid medications in response to allegations made against former CDER director George Tidmarsh (see earlier story). In a statement (contains a link to his letter to FDA commissioner Marty Makary), Hamadeh says he had sent an earlier letter to Makary in August asking him to explain why the agency was taking action against desiccated thyroid medications “that have been safely used for decades.” He says he cautioned that any restrictions would affect patients who rely on the medications and asked what steps FDA would take to ensure that patients’ access to effective thyroid medications would be maintained.

Given Tidmarsh’s departure from FDA following claims made by Aurinia Pharmaceuticals that he used his regulatory authority and official resources to have desiccated thyroid removed from the market, Hamadeh says he wants a withdrawal or indefinite suspension of any enforcement actions brought against any desiccated thyroid drugs on or after the July date of Tidmarsh’s appointment as CDER director, at least until an integrity review can be conducted.

“It was clear to me, based on the feedback that I have received from countless constituents, that FDA’s action against these medications was likely not science-based,” Hamadeh said. “Given our government’s reaction to Covid-19, it is not hard to imagine that bad actors in our government have personal agendas and no regard for science or our citizens. So, I did not hesitate to question FDA’s action that many of my constituents believe would negatively impact their quality of life.”

Hamadeh reminded Makary that FDA’s priority mission should be ensuring drug safety and efficacy, and not unnecessarily restricting access to medications with established track records of safety and effectiveness. “The American people expect that FDA regulatory actions be grounded in science and patient safety,” he wrote, “not personal scores or abuse of authority.”

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

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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