Testimony, Briefings, Statements, & Reports
Testimony of Dr. Mary Carol Jennings to the Reproductive Health Drugs Advisory Committee of the FDA on Paroxetine
Dr. Mary Carol Jennings testifies to the FDA on the risks of using Paroxetine to treat hot flashes. Read More
Testimony of Dr. Mary Carol Jennings to the Reproductive Health Drugs Advisory Committee of the FDA on Gabapentin
Dr. Jennings testifies to the FDA that there is not sufficient evidence to support gabapentin as a safe and effective treatment for hot flashes. Read More
Statement of Dr. Jennifer Yttri at the public hearing on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
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
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
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
Statement from Dr. Jennifer Yttri, senior fellow, at the FDA Public Hearing Establishing a List of Qualifying Pathogens for the GAIN Act
Dr. Yttri testifies to the FDA that the growing risk of antibiotic resistant pathogens and need for development and responsible use of new antibiotics are critical public health concerns that need to be addressed. Read More
Statement by Dr. Diana Zuckerman regarding tragic gun violence in Newtown
The NRA says the assault weapon used in Newtown belongs in our schools. We say gun rights don’t include assault rifles. Read More