Drugs

Cancer Drugs Approved Fastest in U.S.: FOCR

Friends of Cancer Research (FOCR) is promoting updated research continuing to show that cancer drugs are approved faster in the U.S. than in the European Union. In summary, it says in an online Data Driven blog post, between 2003 and 2016, 97% of cancer drugs were available in the U.S. first.

The post references President Donald Trump’s February speech to Congress in which he repeated “a common misconception about drug regulation … that the agency’s drug regulations impede timely access to new medicines.” The group says it explored whether those claims were true about cancer drugs in 2011 and then updated the effort after Trump spoke.

FOCR compared approval times for 73 cancer drugs approved by FDA and the European Medicines Agency (EMA) between 2003 and 2016. The median review times were 183 days (FDA) and 356 days (EMA); drugs approved within six months were 36 for FDA and 1 for EMA; and drugs approved within one year were 70 for FDA and 45 for EMA.

“As we have shown (and others have confirmed), U.S. regulatory reviews do not lag behind other global counterparts,” FOCR says. “When we looked at the data from 2003 to 2016, we found virtually the same disparity in median review times as we did in 2011. When we looked at a related metric, market entry, we found that 97% of drugs approved by both FDA and EMA between 2003 and 2016 were available first in the U.S. Although we don’t expect these findings to eliminate all calls to cut back on drug regulations, our research adds to a growing body of evidence demonstrating that FDA’s current approach to drug regulation has been successful at both speeding patient access and safeguarding patient safety.”

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