Comments on Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose; Effective Date of Requirement for Premarket Approval for Sorbent Hemoperfusion Devices To Treat Hepatic Coma and Metabolic Disturbances

May 17, 2012 — To ensure public health and patient safety, sorbent hemoperfusion devices for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances should remain class III devices and go through the more stringent PMA process, which requires clinical trials and inspections. Continue reading

NRC Comment on a FDA Guidance on the Evaluation of Sex Differences in Medical Device Clinical Studies

March 19, 2012 — The National Research Center for Women and Families has been a long-time advocate of medical device clinical studies including data on safety and effectiveness for women. In this comment letter to the FDA, we describe the importance of analyzing data for women separately and how this information should be used to help women and providers make the best informed decisions. Continue reading

Comments on Proposed Rule: Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices

January 17, 2012 — As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the reclassification of External Pacemaker Pulse Generator Devices (Product code DTE) from class III (high risk devices) to class II (moderate risk devices). These devices are among the “pre-amendment” class III devices, which have been cleared by the less-than rigorous 510(k) process. External Pacemaker Pulse Generator Devices should remain class III devices and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices. Continue reading

FDA needs to provide breast implant patients and physicians with unreported industry data about quality of life, connective tissue symptoms, rupture rates per patient, and other complications

January 5, 2012 — At the FDA Advisory Panel meetings in 2003 and 2005, FDA provided and presented data from the Breast Implant Core studies regarding connective tissue disorder (CTD) signs and symptoms (S/S) and Quality of Life measures. Continue reading

Letter to Dr. Margaret Hamburg, FDA Commissioner, regarding maintaining and strengthening conflict of interest policies for advisory committees

August 3, 2011 — In this letter to FDA Commissioner, Dr. Margaret Hamburg, NRC and other coalition members advocate for stronger conflict of interest requirements for members of FDA advisory committees to protect patients and consumers against industry biases. Continue reading

Letter from the Patient, Consumer, and Public Health Coalition to Jeffrey Shuren, Director, Center for Devices and Radiological Health (FDA), about improving medical device safety

January 18, 2011 — We strongly believe that improving the standards needed to prove safety and effectiveness of medical devices will ensure that U.S. companies flourish and create jobs at the same time as they contribute to public health. Continue reading

Comments to the FDA on “Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner”

June 28, 2010 — These proposed changes are steps in the right direction, but we continue to have strong reservations about DTC prescription drug ads, and we will continue to urge Congress to restrict or ban DTC ads. Continue reading

Comments to the FDA on “Food Additives; Bisphenol A”

June 4, 2010 –The Patient, Consumer, and Public Health Coalition-which includes nonprofit organizations that represent patients, consumers, scientists, and researchers-is commenting on documents prepared by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) regarding the safety assessment of Bisphenol A (BPA). Continue reading

Letter to U.S. Senator Harry Reid (Majority Leader) requesting that he introduce or cosponsor legislation to remove the HPV vaccine from the U.S. Citizenship and Immigration Services (USCIS) requirements

December 4, 2009 — I am writing to inform you of an outrageous new requirement by the U.S. Citizenship and Immigration Services (USCIS) for women applying for visas to enter the United States or adjustment of resident status. Continue reading

Letter to Dr. Margaret Hamburg, FDA Commissioner, urging that immediate attention be brought to appropriately regulate tanning devices

November 5, 2009 — Members of the Patient and Consumer Coalition urge your immediate attention to appropriately regulate tanning devices. As you know, currently, tanning devices are Class I devices (the same as bandages), which is the U.S. Food and Drug Administration’s (FDA) lowest risk device class and does not require comprehensive safety data. Continue reading

Comments to the U.S. Consumer Product Safety Commission on “Statement of Policy: Testing of Component Parts With Respect to Section 108 of the Consumer Product Safety Improvement Act”

September 16, 2009 — Given that phthalate concentrations can be diluted in large toys, we agree with Commission staff that testing phthalate content as a percentage of the entire toy or child care article is less effective than testing materials and component parts that may contain phthalates. Continue reading

Comments to the FDA on “Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket”

September 14, 2009 — The National Research Center for Women & Families submits the following comments regarding the laser-assisted in situ keratomileusis (LASIK) and the post market experience associated with the use of LASIK devices. Continue reading

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

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