Caroline Bradford

Patient, Consumer, and Public Health Coalition Letter to Congresswoman Dingell Thanking Her for Requesting a GAO Report on Post-market Surveillance of Medical Devices

June 7, 2022: We write to express our gratitude as you work to protect patients by promoting post-market review of approved medical devices. Specifically, we greatly appreciate and value your leadership requesting that the Government Accountability Office (GAO) evaluate the current landscape of post-market surveillance of medical devices.

NCHR’s Testimony to FDA on the Novavax COVID-19 Vaccine

June 7, 2022: While this vaccine demonstrates similar levels of efficacy as compared to vaccines approved for COVID-19, the data suggests additional safety risks. Even if it is not proven to be less safe than the other COVID vaccines, it lacks long-term, placebo-controlled efficacy data and there is very little safety or efficacy data for the most at-risk patients. When we already have vaccines on the market that are FDA approved, and based on much better data, why would the FDA authorize this vaccine?

Patient, Consumer, and Public Health Coalition Letter on FDASLA Act of 2022

May 22, 2022: We appreciate the opportunity to submit comments and feedback on the draft legislation, the Food and Drug Administration Safety and Landmark Advancement Act of 2022, which will reauthorize the Food and Drug Administration (FDA) user fee programs.

Costly Alzheimer’s treatment is spreading around the world, with virtually no science to back it up

Stat News, June 1, 2022: Thousands of patients have undergone a type of “shockwave therapy” called transcranial pulse stimulation (TPS) for Alzheimer’s disease and other conditions. The Neurolith device costs patients thousands of dollars but isn’t proven to work. It is not FDA approved for use in the U.S. but Boris Kawliche, a Florida psychiatrist, has been offering TPS at Brandon TMS and Psychiatry clinic since November. Snake oil or treatment?

Patient, Consumer, and Public Health Coalition Letter on FDA Amendments Act H.R. 7667

May 17, 2022: We are writing to express our strong support for several provisions in The Food and Drug Amendments Act (H.R. 7667), and our concerns about other provisions that could be improved. There are numerous important provisions in the FDA Act, but in this letter we will focus on two major issues: accelerated approval and contrast imaging agents.