Statement of Dr. Diana Zuckerman on FDA Approval of New Silicone-Gel Breast Implant Natrelle 410

February 21, 2013. Yesterday the FDA quietly approved yet another questionable style of breast implants, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant made by Allergan, Inc. Unfortunately, Allergan’s studies did not compare the safety and effectiveness of the Natrelle 410 implant to other previously approved silicone gel-filled breast implants on the market.

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Coalition Letter Re: “Questions for Stakeholders Regarding Appropriate Regulation of Pharmacy Compounding”

November 2, 2012. 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.

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Coalition Letter to Congressman Edward J. Markey Regarding the VALID Compounding Act of 2012

October 31, 2012. As members of the Patient, Consumer, and Public Health Coalition, we thank you for your commitment to the health of patients and consumers by introducing the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012. This bill would strengthen FDA oversight of compounding pharmacies in several essential ways, and is clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths.

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