March 11, 2013. Among experts in women’s health and experts in breast cancer, there is considerable concern about Assembly Bill 147 and similar legislation in other states. While we agree that women with dense breasts should discuss the implications of that health condition with their physician, we are concerned that women who receive required form letters are more frightened than informed.
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NCHR Testimony on Creating an Alternative Approval Pathway for Drugs to Address Unmet Medical Need
February 4, 2013. Dr. Yttri testifies at an FDA public hearing that a new, expedited pathway for drug approval is poorly-defined and would promote unproven drugs to high-risk patients.
Read More »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.
Read More »Coalition Letter Regarding FDA’s Recent HELP Committee Testimony on Pharmacy Compounding
November 30, 2012. 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 »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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