A Plea to the FDA

Protesters crash the BIO conference to protest the delayed approval of a breast cancer drug.

Cristina Luiggi
Jun 21, 2012

FLICKR, ASLANMEDIA

Protesters outside the Boston Convention & Exhibition Center, where the Biotechnology Industry Organization’s convention is being held this week, are protesting the US Food and Drug Administration’s (FDA) slow approval of T-DM1, a potential breast cancer therapy that has met success in clinical trials. T-DMI is a combination of Herceptin, which has already been approved for the treatment of breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+), and a new drug made by Immunogen Inc.

In 2010, after successful Phase II clinical trials of the drug, the FDA refused to grant T-DMI accelerated approval, forcing the makers of the drug to go into phase III trials, which are currently ongoing.

“I have been taking this drug for 19 months, with no side effects, and I have no cancer,” an anonymous protester told the Boston Business Journal.

The FDA is currently moving toward changing its drug review process to make...

“Do not believe it when the FDA says it is reforming its process,” another protester yelled at the demonstration. “They are moving slower than ever.”

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