Hagan joins female senators in FDA testing complaint

05/02/2014 12:37 PM

05/02/2014 1:19 PM

Sen. Kay Hagan is one of 15 women in the U.S. Senate who wrote this week to the Food and Drug Administration saying that it should do a better job representing women and minorities in clinical trials for prescription drugs and medical devices.

“Although two decades have passed since FDA published its guideline requiring analysis of data on sex differences in the evaluation of new drugs, we remain concerned about recent evidence that women still are not being adequately represented in clinical trials,” the senators wrote. “As a result, medical treatments may not be as safe and effective for women as they may expect.”

Hagan’s office on Friday released the letter to Commissioner of Food and Drugs Margaret Hamburg, which was dated Wednesday.

As an example, the senators wrote that in February “60 Minutes” reported that the drug Ambien metabolizes differently in women and men, and that women had been receiving an inappropriately high dose.

They also said a report in March by researchers at Brigham and Women’s Hospital said medical treatments available for lung cancer, heart disease, Alzheimer’s and depression were tested largely on men. And they added that the FDA reported last year that there were still gaps in the representation of women in clinical trials and that more needed to be done to make “information about treatment differences readily available to women and their health care providers.”

The FDA plans to release guidelines in the summer as required by law that will detail how it plans to increase the number of women and minorities in clinical trials, Hagan’s office said in a news release.

The letter was signed by 15 of the 20 women who are U.S. senators.

In addition to Hagan, a Democrat from Greensboro, the others were Republican Sens. Kelly Ayotte of New Hampshire, Susan Collins of Maine and Lisa Murkowski of Alaska, as well as Democratic Sens. Tammy Baldwin of Wisconsin, Barbara Boxer and Dianne Feinstein of California, Kirsten Gillibrand of New York, Heidi Heitkamp of North Dakota, Mazie Hirono of Hawaii, Barbara Mikulski of Maryland, Patty Murray of Washington, Jeanne Shaheen of New Hampshire, Debbie Stabenow of Michigan and Elixabeth Warren of Massachusetts.

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