Comments to the Consumer Product Safety Commission on “Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108”

March 25, 2009 — Our groups representing patient, consumer, science and public health interests submit the following comments regarding the draft approach prepared by CPSC staff for determining which products constitute a children’s toy or child care article and are subject to section 108 of the CPSIA. Continue reading

Letter to U.S. Rep. Frank Pallone (Chairman of the Energy and Commerce Subcommittee on Health) supporting the Medical Device Safety Act of 2009

March 2, 2009 — Last year, the U.S. Supreme Court ruled in Riegel v. Medtronic, Inc. that medical devices makers are shielded from personal injury lawsuits, if their defective or unsafe product was approved by the Food and Drug Administration’s (FDA) pre-market approval (PMA) process. Continue reading

Statement of Diana Zuckerman at the FDA Science Board Meeting on the Use of Bisphenol A in Food Containers

February 24, 2009 — We were very pleased with the Science Board’s criticisms of the FDA Draft report on BPA and were disappointed that the FDA has not acknowledged the bottom line criticism: that the FDA drew conclusions about the safety of BPA that were not based on sound science, and that no conclusions can be made about safety until the FDA pays attention to the best studies conducted by federally funded scientists and designs appropriate follow-up research. Continue reading

Letter to U.S. Senators and Reps. urging them to include in the final Consumer Product Safety Commission Reform Act the Senate language that eliminates phthalates in children’s products and childcare articles

May 14, 2008 — Banning phthalates in toys and children’s products will reduce potentially dangerous exposures that could harm children’s development and increase children’s risk of developing cancer and reproductive problems as adults. Continue reading

Letter to Dr. Janet Woodcock (FDA), expressing concern about the Anti-Infective Drugs Advisory Committee (AIDAC) meetingts regarding clinical trial designs for antibiotic treatments for community-acquired pneumonia (CAP)

May 12, 2008 — The undersigned members of the Patient and Consumer Coalition write to express our concerns about the April 1 and 2 meetings of the Anti-Infective Drugs Advisory Committee (AIDAC) regarding clinical trial designs for antibiotic treatments for community-acquired pneumonia (CAP). Continue reading

Statement of Diana Zuckerman, Ph.D., President, National Research Center for Women & Families At the FDA Advisory Panel Meeting, Regarding the NeuroStar TMS System for Major Depression

January 26, 2007 — Depression is a serious and debilitating disease. The use of ineffective treatments can contribute to feelings of hopelessness, which in turn can worsen the symptoms and even result in suicide. Continue reading

Invited Testimony of Diana Zuckerman, PhD, Before the Standing Committee on Health, Canadian Parliament, Ottawa

June 8, 2006 — Clinical trials are a major source of information on the short-term risks of silicone breast implants. In clinical trials, the goal is to follow women prospectively to determine what complications and health problems occur, and to compare that to a control group. Continue reading