National Center for Health Research, Press Release: September 21, 2006
The FDA Scientific Fairness for Women Act Sends Clear Message to the FDA
Washington, D.C. — A key member of Congress, Rep. Rosa DeLauro (D-CT) today announced her introduction of the FDA Scientific Fairness for Women Act. She was joined by Dr. Diana Zuckerman, president of the National Research Center (NRC) for Women & Families; Dr. Susan Wood, former Assistant Commissioner for Women’s Health of the U.S. Food and Drug Administration (FDA), and Ed Brent, a widower whose wife was harmed by FDA’s lack of scientific scrutiny.
“Women deserve medical products that have been scientifically proven to be safe and effective,” said Dr. Zuckerman. “Rep. DeLauro’s legislation prioritizes the importance of science and the health needs of women and helps to ensure that industry pressure and political ideology do not overrule scientific findings.”
“This bill will bring greater assurance that women’s health becomes a priority,” Congresswoman DeLauro stated. “I believe that the gold standard for the FDA has been tarnished, because in fact, FDA decisions are sometimes based on political, corporate and ideological pressures. Decisions should be predicated on science.”
Dr. Susan Wood explained, “Let good science drive the decision. The role of Congress is to have oversight over the FDA and to ensure that it is strong and effective. This bill will try to restore integrity to the FDA and create an office that can shape women’s health and help to make sure data are reviewed appropriately.”
“My wife, P.J., breast-fed two of our daughters after getting implants. Both are seriously ill,” said Ed Brent during the press briefing. “My daughter Catherine is now in a wheelchair. In addition, five major studies, including one by National Cancer Institute, found that women with implants are more likely to commit suicide than other women. After my wife committed suicide, the autopsy showed that she had platinum in her brain tissue, which a CDC scientist said could have influenced her decision to take her own life. That’s why the FDA needs to make sure that the implants being sold now are safe for long-term use, meaning ten years or more.”
Although it is being introduced late in the session, Rep. DeLauro has considerable power as the highest ranking Democrat on the House panel that determines the FDA’s funding every year. The legislation sends a clear message to the FDA about this powerful Congresswoman’s concerns.
Highlights of the legislation include:
FDA Office of Women’s Health
Provide explicit authorization for the Office of Women’s Health within the FDA. The Director for the Office of Women’s Health shall report directly to the FDA Commissioner.
Science on Plan B
Require FDA to convene a workshop within 6 months to review and evaluate current scientific data on the use of emergency contraception by females under 18.
This workshop should address the scientific questions identified in the recent limited approval of Plan B, and should include the appropriate review divisions and the professional scientific and clinical staff within these divisions as participants.
Science on Silicone Breast Implants
Require the FDA to define the life of silicone breast implants, and require their safety to be demonstrated for the life of the device and prior to approval.
Hold FDA accountable for its actions if silicone breast implants are approved by requiring the Secretary to report to Congress within 30 days explaining how the Secretary has complied with the requirements that the safety be demonstrated for the life of the device.
Require FDA to list potential members of FDA’s breast implant advisory committees at least 30 days before the meeting and allow NO exemptions for financial conflicts of interest.
Require FDA to convene and oversee a panel of independent scientists to design and conduct a study on platinum and platinum salts in the bodies and breast milk of women with silicone breast implants.
Controversial products, such as Plan B and breast implants, are often reviewed by an advisory committee that FDA convenes of outside experts. A study by NRC for Women & Families indicates that the FDA advisory panels recommend approval for medical devices, such as implants, 82% of the time.
At the last FDA public meeting on breast implants, in April 2005, the advisory panel recommended against approving Inamed silicone breast implants, and voted to recommend approval of Mentor silicone implants the next day, despite the fact that Mentor had only 2 years of rupture data in their core studies and Inamed had 3 years of rupture data. “At the time, this inconsistency seemed to make no sense,” points out Dr. Zuckerman. “However, our analysis found that none of the 89 randomly selected FDA advisory panels that we studied between 1998 and 2005 ever recommended against approval two times in a row in the same year, let alone the same week. In other words, once the committee recommended against approval for Inamed’s implants, the chances were 100% that they would recommend approval for the product they reviewed the next day. Some question whether the science matters in that situation. That’s why this new legislation is so important.” Meeting transcripts indicated that advisory committee members often publicly apologized to the manufacturers when they did not recommend approval, and they never rejected two products two days in a row.