FDA CDER Head Castigates Pharma Industry

Janet Woodcock believes if everyone can’t be treated, the industry has failed.

Janet Woodcock, head of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) is not happy with the way pharma companies are pursuing drug development and namely, what they are charging for novel medicines.

Speaking quite frankly at a recent conference on Breakthroughs in Medicine sponsored by the Los Angeles Times, Woodcock made it very clear that the industry needs to change the way it operates. Most importantly, she avowed that, if everyone –– meaning the most poverty stricken members of society –– can’t receive the treatments they need, including the latest CAR-T cell or gene therapy, then the industry has failed.

“We need the whole system to evolve and change if we’re going to do what we set out to do: help every patient feel better and live longer,” she insisted.

As an example, she noted that it would have been unimaginable 30 years ago for an effective hepatitis C treatment, if it was ever developed, to not be given to all patients with the disease. Today, cures for hepatitis C are available, but many people go untreated due to the high cost of the drugs.

Part of the problem, Woodcock asserted, was the secrecy in the industry and the unwillingness to share information and reduce the cost of research. She also complained that pharma companies today tend to focus only on aspects of drug development that will provide commercial gain and not on important aspects that can provide basic insights. The lack of support and cooperation with physicians was a third issue for the CDER head.

She said: “You can’t just develop breakthroughs and then throw them over the wall to practitioners,” and “It’s not working, and it won’t work in the future… The goal isn’t just improving knowledge. The goal isn’t FDA approval. The goal is to improve human health.”

Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.