Drugs

FDA Head Califf Discusses Improving Cardiovascular Outcomes

Improved research and technology development, combined with general advances in biological and information technologies, should accelerate improvement in cardiovascular outcomes, opines FDA commissioner Robert Califf in an 8/8 Journal of the American College of Cardiology article. “But if we are to harness these technologies and apply them effectively, our systems for evidence generation and healthcare delivery must continue to improve in concert with drugs, devices, and biological products,” he writes. These advances in technology coupled with increased use of social media use and personal devices could offer new possibilities for treating patients and improving outcomes, but the new approaches must be rigorously evaluated, he says.

In the article, Califf notes that death from cardiovascular disease dropped 40% in the early 2000s and new drug and technology developments will likely further improve outcomes, but he cautions that there is a potential for harm if systems for evidence generation and health care delivery do not improve as rapidly as technology and provide the guidance needed to use new advancements appropriately. “Keeping pace with rapid technological change will present a key challenge,” he says. “It will be critical for the FDA and the cardiovascular community to continue working together to create an evidence generation system capable of guiding practice in coming years.”

Califf observes that while the cardiovascular community is a leader in evidence-based medicine, only about 15% of major practice guidelines are supported by high-quality evidence. However, according to Califf, dramatic improvements in the rate, quantity and quality of evidence generation are within reach. “Almost all Americans now have electronic health records, and social media combined with wearable devices are opening new frontiers in patient- and population-level data,” he says.

Other areas Califf discusses are phenotyping in early-phase clinical trials, integrative biomarkers and monitoring, targeted therapy, devices, regenerative medicine, disease at the beginning and end of life, and quality-of-life and life expectancy disparities.

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