Caroline Bradford

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.

Will the FDA change how it vets drugs following the Alzheimer’s debacle?

Nature, May 13, 2022: Nearly a year after the FDA approved a controversial drug to treat Alzheimer’s disease, Congress is attempting to amend the accelerated process that led to its approval and also the approval of many cancer drugs that have not been proven to work.

Nonprofit Consumer and Public Health Organization’s Letter To FDA Regarding Transparency Of The MDUFA V Reauthorization Process

March 4, 2022: We write today to follow up on your response to several requests for information at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Medical Device User Fee Amendments (MDUFA V) stakeholders meeting on February 28, 2022.