Risk averse? Not us, says top FDA official

Is a rising tide of risk aversion at a post-Vioxx FDA behind the agency's anemic approval record? No way, say the FDA's Janet Woodcock (photo). It's all about the science. And the science, she insists, is pointing to troubling indicators about some of these new drugs.

"We have a different story from the companies," Woodcock told the Financial Times. "We understand that [they] have productivity issues but [we] stick to the same safe and effective criteria as our bedrock. Pharma is having a difficult time but we are seeing drugs that have a lot of questions."

The length and size of clinical trials are growing, Woodcock acknowledges, but that's because regulators know more about what they need by way of data. And new efforts to standardize trials--à la Henry Ford--should help matters. "We need to learn from Henry Ford. Companies collect too much information because they are worried that the FDA will ask for it."

- check out the article in the Financial Times

Related Articles:
2007 FDA approvals. Report
More mixed messages from the FDA. Report
FDA: Hyper-cautious or simply vigilant? Report

Suggested Articles

The FDA accepted the regulatory filing for Biogen's once-failed Alzheimer's drug, aducanumab, with plans to decide its fate by March 7, 2021.

Alexion named a chief diversity officer, while COVID-19 vaccine player has two new members of its C-suite.

Scientists at Sanford Burnham Prebys suggested that inhibiting the PPP1R1B protein could be a new strategy for treating pancreatic cancer.