FDA Policy/General

Possible Agenda for Scott Gottlieb as FDA Boss

Faster drug approvals and more medical device apps might be among the first issues tackled by former FDA deputy commissioner Scott Gottlieb if he is named commissioner, according to an Endpoints News analysis. The online post says that while other names are also being floated as possible commissioner candidates, Gottlieb is the only one who would be welcomed by most people in the biopharmaceutical industry. He would continue the tradition of having a doctor as commissioner, the report says, and would arrive as a reformer who has a good understanding of the agency’s inner workings and thus could swiftly execute a series of changes that would meet President Donald Trump’s stated goal of accelerating approvals and dramatically lowering drug prices.

The analysis of a six-month agenda is based on Gottlieb’s writings and speeches over the last few years as he and the other potential candidates are keeping a low profile before any nomination is made.

The first change Endpoints sees is to reform FDA rules for approving complex generic drugs. Gottlieb has been calling for more flexibility in approving generic versions of complex therapeutics. While he has called for legislation, the post says that an aggressive commissioner could go a long way to clearing the path for complex generics. “Look for some quick, broad guidance that would give developers a clear regulatory path for the class, tossing aside the more cumbersome case-by-case method that has been in use, often long after these rivals could have made it to the market,” it says.

Another quick priority, according to the report, could be expanding the breakthrough therapy designation throughout more of the agency. He would be likely to install a team of regulators tasked with ramping up the review process in specific divisions that have lagged behind, it says.

Other areas of early interest could be making FDA more of a facilitator than an obstacle for medical device apps and publishing complete response letters to keep drug developers more honest about why their applications have not been approved.

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