FDA Policy/General

Praise for Gottlieb Amid FDA Successes in 2017

A Health Affairs year-in-review says that one of the biggest drug policy stories in 2017 was the bipartisan cooperation that led to passage of the FDA Reauthorization Act of 2017 that continued the FDA user fee program. The review also says that FDA commissioner Scott Gottlieb has established himself as one of the strongest, most effective agency heads in the Trump administration.

It praises him for decisive action on priorities like the opioid crisis, potential drug and device shortages caused by the devastation in Puerto Rico, and generic drug competition. “In general,” the report says, “Gottlieb has demonstrated his commitment to science- and evidence-based policy, supported by a strong agency staff.”

One issue the article raises is the question of what evidence will be sufficient to support FDA approval of new drugs. “If Commissioner Gottlieb is moving the agency toward the approval of drugs on the basis of less (or even just less rigorous) evidence,” author Rachel Sachs writes, “it is my hope that he will consider the consequences for the system as a whole—particularly our public reimbursement system, which for now must cover most or all FDA-approved drugs, regardless of evidence—in doing so.”

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