Letters to Government Officials
Comments from Members of the Patient, Consumer, and Public Health Coalition Re: FDA’s Recent HELP Committee testimony on pharmacy compounding
As members of the Patient, Consumer, and Public Health Coalition, we welcome the opportunity to provide our views regarding FDA Commissioner Margaret Hamburg’s November 15, 2012 testimony at the HELP Committee hearing, “Pharmacy Compounding: Implications of 2012 Meningitis Outbreak.” Read More
Comments from Members of the Patient, Consumer, and Public Health Coalition Re: “Questions for Stakeholders Regarding Appropriate Regulation of Pharmacy Compounding”
Members of the Patient, Consumer, and Public Health Coalition welcome the opportunity to provide our views regarding pharmacy compounding. Stronger regulations are clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths. Current laws and regulations regarding compounding pharmacies have resulted in giant loopholes that allow medical products that are neither safe nor effective to be sold throughout the country, putting patients’ lives at risk. Read More
Letter to U.S. Senators in opposition of efforts to delay or repeal excise tax on medical devices
As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose efforts to delay or repeal the 2.3% excise tax on medical devices. Read More
Letter to Dr. Joshua Sharfstein, Maryland’s Secretary of Health, in support of banning the sale of baby bumper pads in Maryland, September 28, 2012
The ASTM standard that claims some bumper pads are less risky will muddle the safety issue even more and give parents a false sense of security. Maryland’s proposed ban on crib bumper pads will help to protect more than 70,000 babies born in the state each year, and that is a bottom line upon which we should all agree. Read More
Letter to Representative Markey in Support of Legislation that Would Give the FDA Authority to Oversee Compounding Pharmacies, October 31, 2012
This letter expresses support for Massachusetts Representative Ed Markey’s proposed legislation that would give the FDA more authority over compounding pharmacies. Read More
Letter to Dr. Woodcock, FDA Director for the Center for Drug Evaluation and Research on the approval of Qnexa, a weight-loss drug
In this letter, NRC and other women’s organizations urge the FDA to not approve Qnexa, a weight loss drug, because of serious unresolved safety concerns about its potential to cause cardiovascular harm and birth defects. Read More
NRC Comment on a FDA Guidance on the Evaluation of Sex Differences in Medical Device Clinical Studies
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. Read More
Letter to Dr. Hamburg, FDA Commissioner on the Review of Drospirenone (DRSP)-based Oral Contraceptives
March 9, 2012 Margaret Hamburg, M.D. Commissioner Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002 Re: FDA Review of Drospirenone (DRSP)-based Oral Contraceptives Dear Commissioner Hamburg: We are writing to follow up on our meeting with … Read More
Letter from the Patient, Consumer and Public Health Coalition to Dr. Margaret Hamburg on the De Novo Process and High-Risk Medical Devices
February 28, 2012. In this letter to the FDA Commissioner, the Patient, Consumer, and Public Health Coalition expresses their concerns over the de novo approval process for high-risk medical devices, specifically a endovascular suturing system. Read More
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 Dr. Jeffrey Shuren, Director Center for Devices and Radiological Health Food and Drug Administration Silver Spring, MD 20993 RE: FDA Needs to Provide Breast Implant Patients and Physicians with Unreported Industry Data about Quality of Life, Connective … Read More