Murkowski Working with FDA to Protect Alaskan Women’s Health

Senator Seeking to Ensure Women, Minorities Fairly Represented in Medical Trials

Senator Lisa Murkowski and 14 of her women Senate colleagues are urging the Obama administration to stand up for women’s health and to make sure medical treatments are safe and effective for women.  In a letter (attached) to the Food and Drug Administration (FDA), Murkowski and her colleagues are asking that more women and minorities be included in clinical trials to ensure accurate information on the safety and effectiveness of new drugs and medical devices is made available.

Though this action is required by law due to the bipartisan efforts of Senators Murkowski and Debbie Stabenow (D-MI), the two wanted to underscore its critical need – as evidenced most recently by a “60 Minutes” segment demonstrating the enormous discrepancy between drug effects on men and women.

“Medical trials are incredibly important at gauging the safety and efficacy of drugs and treatments, but the truth is that people react to medication differently – and medical trials should reflect that reality,” said Murkowski.  “By not paying proper attention to women and minorities, we are putting their health at greater risk; rethinking the methods used for trials will help address these risks and not cost the FDA an extra dime.”

Women and minorities are not fairly represented in the testing of medical treatments, even though they can react differently to some treatments.  The FDA will issue an action plan this summer detailing how it plans to increase the number of women and minorities in clinical trials as required by law; the Senators’ letter is intended to press this point further.

The letter reads, in part: “Although two decades have passed since the 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.  As a result, medical treatments may not be as safe and effective for women as they may expect.… The Action Plan represents a key opportunity to address these concerns.  We hope that, 20 years from now, we can look back and say that the FDA’s plan was a significant milestone in women’s health – not a missed opportunity.”

The letter is also signed by Sens. Kelly Ayotte (R-NH), Tammy Baldwin (D-WI), Barbara Boxer (D-CA), Susan Collins (R-ME), Dianne Feinstein (D-CA), Kirsten Gillibrand (D-NY), Kay Hagan (D-NC), Heidi Heitkamp (D-ND), Mazie Hirono (D-HI), Barbara Mikulski (D-MD), Patty Murray (D-WA), Jeanne Shaheen (D-NH), Debbie Stabenow (D-MI) and Elizabeth Warren (D-MA).