FDA Policy/General

Senate Passes Cures Act and Sends to Obama’s Desk

One week after the House passed the 21^st Century Cures Act, the Senate has voted 94 to 5 to pass the bill, and it now heads to president Obama’s desk for signing. After the vote, Senate Health, Education, Labor and Pensions committee chair Lamar Alexander (R-TN) called the measure the “the most important bill of the year.” Alexander said the legislation will “help us take advantage of the breathtaking advances in biomedical research and bring those innovations to doctors’ offices and patients’ medicine cabinets around the country. This legislation will advance vice president Biden’s moonshot to find cures for cancer, President Obama’s Precision Medicine Initiative, and the BRAIN Initiative – and it will help states in the fight against opioid abuse and the one in five adults in this country suffering from a mental illness. I look forward to the president’s signature.”

The legislation will help bring drugs and devices to market more quickly and at less cost by making needed reforms to the Food and Drug Administration (FDA), including: expedited review for breakthrough devices, increased patient involvement in the drug approval process, a streamlined review process for combination products that are both a drug and device, and freedom from red tape for software like fitbits or calorie counting apps, Alexander said. It also will provide $4.8 billion to National Institutes of Health, including: $1.8 billion for the “Cancer Moonshot” to speed cancer research; $1.4 billion for President Obama’s Precision Medicine Initiative to drive research into the genetic, lifestyle and environmental variations of disease; and $1.6 billion for the BRAIN Initiative to improve our understanding of diseases like Alzheimer's and speed diagnosis and treatment.

Additionally, the Cures Act will provide $500 million to FDA over 10 years, and $1 billion in grants to states to address the opioid crisis. It will also provide:

Improved electronic health records for doctors and their patients.
An extension of the Rare Pediatric Disease Priority Review Voucher Program, which incentivizes the development of new therapies to help the more than 15 million children with rare diseases;
A streamlined FDA review of genetically targeted and protein variant therapies for rare diseases.

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