Drugs

Gottlieb Weighs in on Coronavirus Therapies

As president Trump and his allies daily tout the off-label use of the malaria drug hydroxychloroquine for treating caronavirus patients, former FDA commissioner Scott Gottlieb says that if the drug is working, its “effect is probably subtle enough that only rigorous and large scale trials will tease it out.” In a 4/5 Twitter thread, Gottlieb said that anyone who believes it needs to be made available should be assured that it is available and has been widely used for months all around the world. “Doctors have been using it widely in U.S., often in combo with azithromycin, since the very outset,” he said. “They used it based on a theoretical potential for benefit, the fact that it was widely available, and a perception that the side effect profile is understood and so risk/reward is favorable.”

Gottlieb’s Twitter posts followed a 4/5 Wall Street Journal commentary about the promise of antiviral and antibody drugs under development for treating caronavirus. The antiviral drugs target the virus and block its replication, while antibody drugs mimic the function of immune cells. Antibody drugs can be used to fight an infection and reduce the risk of contracting Covid-19. Gottlieb* said antibody drugs may be the best chance for a meaningful near-term success.

“But success will require a strong sense of urgency from manufacturers — and from regulators, who need to collaborate with drug developers in innovative ways to move the most promising therapies,” Gottlieb wrote. He urged FDA to use a cancer drug review program, real-time review, where “regulators work with drug developers to evaluate data as it is read out from clinical trials, instead of waiting until the trial concludes, to understand the potential benefits and risks rapidly. This has enabled drug developers to accelerate development timelines. FDA’s senior career scientists need the firm backing of political leadership to apply these and similar scientific approaches to Covid-19.”

* Gottlieb is the only FDA commissioner candidate to have been endorsed by FDA Webview and its precursors in 38 years of FDA news publishing.

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

Read more

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