November 28, 2012. 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 »On Medical Treatments & Products
Testimony to FDA Advisory Committee on Intra-Aortic Balloon Pumps
December 5, 2012. We strongly agree with the FDA that IABP devices used to treat septic shock and Intraoperative Pulsatile Flow Generation should remain Class III, with PMAs required. The evidence of safety and effectiveness for these indications has yet to be established.
Read More »Testimony to FDA Advisory Committee on External Counter-Pulsating (ECP) Devices
December 5, 2012. We do not support the FDA’s recommendation to down-classify ECPs for refractory chronic stable angina. We would support allowing the ECPs that are currently on the market to be allowed to stay on the market with labeling to include the phrase “all 510(k) cleared ECPs are prohibited from being used for any indication other than refractory chronic stable angina.” We urge you to require all new versions of ECPs to be classified as Class III and go through the more rigorous PMA process for any uses.
Read More »NCHR Testimony to FDA to Advisory Committee on Beyaz and Similar Oral Contraceptives
September 11, 2012. Sonia Nagda, a Senior Fellow at NRC, testifies at a Pediatrics FDA Advisory Committee meeting on the use of drospirenone-containing oral contraceptive, Beyaz, in pediatric populations.
Read More »Testimony at FDA Advisory Committee Hearing on Metal-on-Metal Hip Implants
June 27, 2012. Metal-on-metal hip implants were approved by the FDA without requiring clinical studies before approval or following patients after their surgery for potential side effects. Now, 500,000 patients have metal-on-metal implants that have been widely reported to wear down and create metal debris inside patients’ bodies. Dr. Zuckerman testifies to the FDA about the lack of long-term clinical trials at their Advisory Committee hearing.
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