High Value Health Care

PIRG meets with FDA Commissioner Califf to discuss safety of prescription drugs and diagnostic tests

Meeting at the FDA with senior leadership and consumer/patient groups

Nineteen patient and consumer groups met with Commissioner Califf and his senior staff to discuss a variety of patient safety priorities on March 1, 2023. 

Dr. Diana Zuckerman of the National Center for Health Research thanked the Commissioner for his efforts to improve the FDA’s prescription drug approval program by requiring pharmaceutical companies to begin full clinical trials before any drug is granted “accelerated approval” to sell their medication. By requiring these quick-to-market drugs to undergo full trials, patients will be better protected from harm not identified in the shorter trials and will confirm that the drugs work as predicted. 

PIRG’s senior director of health policy, Patricia Kelmar, urged the FDA to begin stronger oversight and regulation to lab-developed diagnostic tests to ensure their accuracy and safety. “Many patients make serious decisions about their health, such as undergoing surgeries or beginning chemotherapy, based on diagnostic tests that might not be accurate and reliable,” said Kelmar.

Kim Witczak of WoodyMatters and Suzanne Robotti of MedShadow presented recommendations to improve how patients and consumers can engage in FDA decision-making.  

We plan to follow up in more detail with all of these patient safety priorities.

Our group in the photo below: PIRG’s senior director of health care campaigns, Patricia Kelmar, in center.

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