Senator Ron Johnson launches a formal investigation into the Food and Drug Administration and will seek the agency's written denial letters and may summon FDA Commissioner Marty Makary to testify before his subcommittee.The inquiry follows reporting that the FDA rejected or delayed about 20 experimental therapies for rare diseases, sometimes asking companies such as uniQure NV for costly new trials and prompting outrage from patient advocates over yearslong delays and higher costs.The Department of Health and Human Services and the
FDA defend a cautious, science driven approach and note a draft framework to speed customized treatments even as Johnson cites oversight concerns for patients with terminal illnesses.