Public Policy
Letter to CMS urging the release of the Sunshine Act final regulations
As members of the Patient, Consumer, and Public Health Coalition, we strongly urge CMS to release the Sunshine Act final regulations as quickly as possible. Read More
Letter to Congressman Edward J. Markey on the VALID Compounding Act of 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. Read More
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
Notre Dame Football Players Rape Cover-up – What’s in the News and What Isn’t
Fem2.0 January 9, 2013. The media has extensively covered the college championship football game between Notre Dame and Alabama, but few Americans aware of Notre Dame’s cover-up of rapes by Notre Dame football players. Monday’s football game is an opportunity to acknowledge that raping women is a terrible crime that needs to be taken seriously by the police, the public, and the media. 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
Testimony of Dr. Jennifer Yttri to the Anti-Infective Drugs Advisory Committee of the FDA on Bedaquiline
Dr. Yttri testifies to the FDA Committee that the data on bedaquiline indicate that the benefit to patients with multi drug resistant tuberculosis is questionable. The FDA’s responsibility is to approve drugs that will help, not harm, consumers. Treatments exist for patients with multi drug resistant tuberculosis that are safer without the addition of bedaquiline. Read More
Testimony of Dr. Jennifer Yttri to the Anti-Infective Drugs Advisory Committee of the FDA on telavancin (VIBATIV)
Dr. Yttri testifies to the FDA that there is not sufficient evidence to support telavancin as a safe and effective treatment for nosocomial pneumonia. The data raise questions about a high morality rate associated with telavancin. Read More
Testimony of Dr. Jennifer Yttri to the Neurologic Devices Advisory Committee of the FDA on NeuroFlo
Dr. Yttri tesifies to the FDA that the clinical utility of the NeuroFlo device for the SENTIS subject population should be carefully assessed, considering both the lack of benefits and increased risks with an unnecessary procedure. Read More
Statement by Senior Fellow Jennifer Yttri, PhD, at FDA Public Hearing on Antiseptic Preoperative Skin Preparation Products
Dr. Yttri testifies to the FDA on the serious public health issue of contamination of antiseptic products. First, we support the recommendation of the August 2009 Advisory Committee in ensuring that all antiseptic patient preoperative skin preparation products are held to current good manufacturing practice (GMP) standards. Second, the FDA should remove ineffective antiseptics from the market. Third, as extrinsic contamination accounts for the majority of contamination outbreaks, FDA should require product packaging that would reduce extrinsic manipulation. Finally, while the majority of outbreaks seem to be related to extrinsic contamination, intrinsic contamination introduced during manufacturing most likely accounts for a greater number of contaminated products. Read More