Testimony on Generic Drug Labeling before FDA by Anna E. Mazzucco, Ph.D.

March 27, 2015. The current situation creates a terrible double standard, making patient with generic drugs second class citizens. And, when brand name drug manufacturers leave the market after generics become available, nobody is held responsible for updating the label. This is completely unacceptable. Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan on the Dietary Guidelines Advisory Committee’s report

March 24, 2015. We strongly agree with the Dietary Guidelines Advisory Committee’s report of a healthy diet as one that is: higher in fruits, vegetables, whole grains, low-fat dairy, seafood, legumes, and nuts; lower in red and processed meats; low in sugar-sweetened foods and drinks; and lower in sodium. Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan before the FDA Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee discussing a new drug application for Asthma

March 19, 2015. Long-acting beta-agonists have a history of serious adverse events in asthma patients including a four-fold increase in asthma-related death. So, let’s start with the assumption that we don’t want a new LABA on the market unless we have good evidence about safety and efficacy. Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan before the FDA committee on Dermatologic and Ophthalmic Drugs on clinical trials for Atopic Dermatitis in pediatric patients

March 9, 2015. Atopic dermatitis affects a very young patient population, so it critical to have safety information for all age groups to prevent dangerous off label use. This is a vulnerable patient population, and the benefits for the treatment must be proven to outweigh the risks. Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan before the FDA committee on Vaccines and Related Biological Products

March 4, 2015. An effective flu vaccine is critical for public health. Antiviral medications have very limited efficacy, so for many people the flu vaccine is the best line of defense to protect against infection. The CDC’s latest report calculated a 19% vaccine efficacy this year. That is simply not good enough. More importantly, this is not just one bad year. Four of the last 10 years the vaccine has been less than 40% effective. Continue reading

Testimony of Dr. Christina Silcox Before the FDA Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee on the Superion InterSpinous Spacer Device

February 20, 2015.

Lumbar spinal stenosis is the most common indication for spine surgery in patients older than 65, and its prevalence in the United States is expected to rise 59% by the year 2025. That means that the FDA’s decision about whether or not to approve this device will affect the lives and health of many men and women. The Superion IDE trial shows that the Superion ISS Device is non-inferior to the X-Stop device. But does that mean it should be approved? Continue reading