Drugs

Bloomberg Businessweek Reviews Valsartan Contamination

A lengthy Bloomberg Businessweek report looks at the ongoing issue of N- nitrosodimethylamine (NDMA) contamination in the widely-used hypertension medicine valsartan. The contamination led FDA in 7/2018 to oversee a recall of drugs from three companies. There have been 51 additional recalls since then, including two additional drugs, irbesartan and losartan, made by at least 10 companies.

Bloomberg says that while FDA has a rigorous approval process for new drugs, companies manufacturing generic drugs only have to show that patients will absorb them at the same rate as the branded medications they mimic.

“At least 80% of the active pharmaceutical ingredients for all drugs are made in Chinese and Indian factories that U.S. pharmaceutical companies never have to identify to patients, using raw materials whose sources the pharmaceutical companies don’t know much about,” the story says. “FDA checks less than 1% of drugs for impurities or potency before letting them into the country. Surveillance inspections of oversea factories have declined since 2016, even as the agency is under pressure to get more generics to market quickly. Where FDA’s drug approval process is founded on testing and more testing, the regulatory system for generics is built on trust, specifically trust in manufacturers.”

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