Drugs

Califf Touts Progress in Drug Compounding Oversight

FDA commissioner Robert Califf says that over the past 10 years FDA and state regulators “have worked hard to strengthen our oversight of drug compounding.” Speaking on 11/1 at the 11th Annual Intergovernmental Working Group Meeting on Drug Compounding, Califf recognized that it has been 10 years since an outbreak of fungal meningitis sickened more than 700 people and was associated with 64 deaths. “I know that we are all driven by the memory of those patients and their families to make compounded drugs as safe as possible, and to do everything we can to prevent harm on this scale,” he said.

Califf said FDA has made great strides to implement federal law on drug compounding following the passage of the Compounding Quality Act in 2013 by:

establishing an Office of Compounding Quality and Compliance;
publishing more than 50 policy documents on compounding;
taking regulatory actions to prevent contaminated and unsafe compounded drugs from reaching patients; and
launching the Compounding Quality Center of Excellence.

While great progress has been made, he said, many areas still need work, including upcoming rulemaking on provisions in federal law about certain distributions of compounded drugs and a memorandum of understanding between FDA and states.

Califf said that as compounding business practices evolve, regulators must do the same. “Increasingly, we see a need to work with our colleagues in boards of medicine, nursing, and other health professions to better understand practices and challenges in their space and to ensure that new and unsafe practices don’t emerge without proper oversight,” he said. “We must continue to balance the clarion call to protect patients from unsafe, ineffective, and poor-quality compounded drugs with the equally important goal of supporting access to high-quality compounded drugs for patients who have a medical need for them.”

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