Comments of members of the Patient, Consumer, and Public Health Coalition on “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications”

As members of the Patient, Consumer, and Public Health Coalition, we support FDA’s effort to better characterize drug interactions with hormonal contraceptives since reliable and accurate information is necessary to ensure women’s health. In particular, we recommend clinical evaluation of drug interactions for all drugs that are likely to be used in women of reproductive age and that have the potential to cause birth defects, in addition to improving the quality and usefulness of information in FDA-approved labeling. Continue reading

FDA revisits safety of the Essure contraceptive device

NPR, 2015: Many women rely on birth control throughout their lives to prevent unwanted or untimely pregnancies. The Essure contraceptive device is placed in the fallopian tubes essentially sterilizing the woman. This alternative to traditional sterilization methods has caused immense harm to many women and provoked strong responses from patient advocacy organizations and professionals in the health care industry. Continue reading

F.B.I. investigates whether harm from surgical power tool was ignored

The New York Times, May 27, 2015. The Federal Bureau of Investigation has begun looking into whether medical device makers, doctors and hospitals broke the law by failing to report problems linked to a power tool used during gynecologic surgery, according to two people who said they were interviewed by investigators. Continue reading

Testimony on Generic Drug Labeling before FDA by Dr. Anna E. Mazzucco

March 27, 2015. The current situation creates a terrible double standard, making patient with generic drugs second class citizens. And, when brand name drug manufacturers leave the market after generics become available, nobody is held responsible for updating the label. This is completely unacceptable. Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan on the Dietary Guidelines Advisory Committee’s report

March 24, 2015. We strongly agree with the Dietary Guidelines Advisory Committee’s report of a healthy diet as one that is: higher in fruits, vegetables, whole grains, low-fat dairy, seafood, legumes, and nuts; lower in red and processed meats; low in sugar-sweetened foods and drinks; and lower in sodium. Continue reading